This Blog is for All Things Cleanrooms, Testing, Monitoring, & More

Understanding Total Coliform Testing in Drinking Water: A Comprehensive Guide

Fri, 01 Mar 2024 15:21:00 GMT

What is Total Coliform Water Testing and Why is it Important?

Total coliform testing is a method used to determine the presence of coliform bacteria in drinking water. Coliform bacteria are a group of microorganisms that are naturally present in the environment, including in soil, vegetation, and the intestines of warm-blooded animals.

Total Coliforms are a broad category of bacteria, and their presence in water indicates possible contamination . This testing is crucial for assessing the microbial quality of drinking water. It serves as an indicator of potential fecal contamination and the presence of other harmful pathogens. Monitoring total coliform levels helps water authorities and health agencies identify and address issues related to water quality to prevent waterborne diseases.

Total coliform testing detects various organisms, including Escherichia coli (E. coli), Klebsiella, Enterobacter, and Citrobacter, among others. While not all coliform bacteria are harmful themselves, their presence suggests possible contamination by fecal matter or other pathogens, which could pose health risks. Measuring total coliform in drinking water is essential for safeguarding public health. Contaminated water can cause gastrointestinal illnesses, such as diarrhea, vomiting, and stomach cramps. By monitoring total coliform levels, water authorities can take preventive measures to ensure water safety and protect consumers from waterborne diseases.

Interpreting Total Coliform Results

Positive Result: A positive result indicates the presence of total coliform bacteria in the water sample. Further testing, such as fecal coliform or E. coli testing, may be necessary to confirm fecal contamination and assess the severity of the issue.

Negative Result: A negative result means that no total coliform bacteria were detected in the water sample. While it suggests that the water is free from total coliform contamination, periodic testing is still necessary to monitor water quality and ensure continued safety.

Total coliform testing is significant because it provides early warning signs of potential water quality problems. By detecting coliform bacteria, water authorities can take corrective actions, such as disinfection or source water protection, to prevent contamination and ensure that drinking water meets regulatory standards.

When is Total Coliform Water Testing Necessary?

Total coliform water testing is necessary in various circumstances:

Routine Monitoring: Regular testing is essential to monitor the microbial quality of drinking water and comply with regulatory requirements.
After Disinfection: Testing is conducted after disinfection processes to ensure that the water remains free from microbial contamination.
Following Water Quality Incidents: Testing is performed following incidents such as flooding, sewage spills, or other events that may compromise water quality.

In conclusion, total coliform testing is a critical aspect of ensuring the safety and quality of drinking water. By understanding its significance, interpreting results accurately, and conducting testing, when necessary, we can protect public health and prevent waterborne diseases.

At Sure-BioChem Laboratories, our top priority is ensuring the safety and purity of your drinking water. We understand the crucial role that clean water plays in public health and well-being. That's why we are dedicated to providing accurate and reliable total coliform testing services to help safeguard communities against waterborne contaminants.

Understanding the Importance of Bacillus cereus Testing

Tue, 12 Dec 2023 16:37:00 GMT

What is Bacillus cereus

Bacillus cereus is a spore-forming bacterium commonly found in soil, dust, and some raw foods. Among the array of bacteria scrutinized in food testing, Bacillus cereus stands out as a significant concern due to its capacity to cause foodborne illness. This bacterium can thrive in a range of conditions, making its presence a concern in food production and handling. Food and environmental laboratories often conduct Bacillus cereus testing to assess the safety and quality of food products. This testing is particularly relevant in industries involving the production and handling of foods, as well as in healthcare settings where monitoring environmental contamination is crucial. The testing typically involves collecting samples from food products, surfaces, or other relevant sources and then culturing and analyzing these samples to detect the presence of Bacillus cereus and, if applicable, its toxin-producing capabilities. Results from Bacillus cereus testing can help ensure the safety of food products and contribute to the prevention of foodborne illnesses.

The Significance of Bacillus cereus Testing

Food Safety Assurance : Testing for Bacillus cereus is integral to ensuring that food products are free from harmful levels of this bacterium and its associated toxins. This is crucial for preventing foodborne illnesses in consumers.
Quality Control in Food Industries : Food production and processing facilities conduct Bacillus cereus testing as part of quality control measures. Detecting and mitigating potential contamination helps maintain the integrity of food products.
Compliance with Regulatory Standards : Adhering to stringent regulatory standards set by food safety agencies requires regular testing to monitor and control Bacillus cereus levels in food products.

Method of Bacillus cereus Testing

Microbiological Culture Methods: Traditional methods involve culturing samples on specific media to encourage the growth of Bacillus cereus. Colonies are then examined for characteristics specific to this bacterium.
Molecular Techniques : Polymerase Chain Reaction (PCR) assays are used for rapid and precise detection of Bacillus cereus DNA, providing quicker results compared to traditional culture methods.

3. Toxin Detection : Some tests focus on detecting the toxins produced by Bacillus cereus, as the presence of these toxins is an indicator of potential food safety risks.

Ensuring Food Safety Through Rigorous Testing

Food safety is a collective responsibility that involves producers, regulators, and testing laboratories. Bacillus cereus testing is an essential component of this process, ensuring that food products meet stringent safety standards and are free from harmful microbial contaminants.

At testing facilities like ours, employing stringent protocols, we prioritize accurate and timely Bacillus cereus testing. Our commitment to excellence in food safety analysis aims to support the food industry in delivering safe and high-quality products to consumers.

In conclusion, the vigilance in testing for Bacillus cereus serves as a cornerstone in the ongoing efforts to maintain food safety, assuring consumers that the products they consume are free from potential hazards associated with this bacterium.

Optimizing Food Safety: The Science of Shelf Life Testing

Tue, 17 Oct 2023 14:43:00 GMT

Understanding the shelf life of the product we consume is crucial for comprehending the nutritional value they offer. As consumers, we rely on the quality of our food to be fresh and of the highest standard. It is through quality control measures like shelf-life studies that we can enjoy our meals and beverages with confidence, knowing that they won’t jeopardize our well-being.

What is Shelf-Life Testing

The shelf life of a product is a means of establishing its longevity, commonly referred to as the “best before” or “expiration” date. This assessment, known as shelf-life testing or shelf-life stability testing, is an evaluation conducted within a food safety laboratory. It serves to measure the product’s durability, precisely pinpointing how long it retains its suitability for consumption before shadowing signs of degradation or becoming unsuitable.

Some factors that affect the shelf life of the products are the food’s composition, storage conditions, packaging, and the presence of preservatives or additives. An understanding of these factors is fundamental for effective shelf life testing.

Types of Shelf-Life Testing

There are various types of shelf-life studies depending on the product and industry. Some common types include.

Microbiological Shelf-Life Study: this focuses on the growth of microorganisms like bacteria, yeast and molds over time. It is a key factor in identifying spoilage.
Real Time Shelf-Life Study: this involves monitoring the product over a period of time. The product is stored under normal or recommended conditions, and its quality and safety are periodically assessed.
Chemical Shelf-Life Study: this focuses on analyzing the chemical composition of the product, such as levels of vitamins, antioxidants, or the formation of undesirable compounds. Changes to these elements can indicate product deterioration.
Comparative Shelf-Life Study: two or more products are compared to assess their shelf life. This is commonly used when reformulating a product, changing packaging or comparing different brands.
Accelerated Shelf-Life Study : involves subjecting the product to elevated conditions that speeds up the aging process. This helps determine the product's shelf life quickly and is often used in the developmental process of new products.

These various forms of shelf-life testing allow manufacturers, food scientists, and quality control experts to ensure that the products we purchase are not only safe but also maintain their intended quality and nutritional value. The next time you savor a fresh, delicious meal or open a perfectly preserved product , remember that behind that confidence lies the science of shelf life.

Understanding Heterotrophic Plate Count (HPC) in Process Water: A Key to Quality Assurance

Tue, 26 Sep 2023 14:04:00 GMT

In the world of water quality and safety, monitoring microbial contamination is paramount. One crucial tool in this effort is the Heterotrophic Plate Count (HPC) method. This method is especially valuable when it comes to process water, which is used in various industrial applications, including pharmaceuticals, food production, and more. In this blog, we'll dive into what HPC is, why it matters, and how it plays a vital role in ensuring the quality and safety of process water.

What is Heterotrophic Plate Count (HPC)

Heterotrophic Plate Count , often abbreviated as HPC, is a microbiological testing method used to estimate the total count of aerobic heterotrophic bacteria in water. These are organisms that rely on organic carbon as their energy source. HPC is a broad measure that encompasses a wide range of microorganisms, including bacteria, yeasts, and molds. The test involves plating a sample of water onto a solid growth medium, which provides nutrients for the bacteria to grow and form visible colonies.

Why Measure HPC in Water

Quality Assurance: Maintaining the quality of process water is critical in industries like pharmaceuticals and food production. Elevated HPC levels can indicate potential contamination, which may affect product quality and safety.

Health and Safety: For industries where processed water comes into contact with products or is used for cleaning and sanitizing, high HPC counts can pose health risks to consumers or workers.

Regulatory Compliance: Regulatory bodies often set specific HPC limits for process water in various industries. Adhering to these limits is essential to ensure compliance and avoid regulatory issues.

How is HPC Measured

The test involves the following steps.

Sample Collection : A representative sample of process water is collected using a sterile container.

Sample Incubation: The sample is spread evenly over a solid agar medium in a petri dish. This medium contains nutrients that support bacterial growth.

Incubation: The petri dishes are then incubated at a controlled temperature (usually 35°C) for a specific period, typically 48 hours.

Counting Colonies: After incubation, colonies of bacteria that have grown on the agar plates are counted. The results are reported as Colony-Forming Units per milliliter (CFU/ml) of water.

Interpreting HPC Results

Interpreting HPC results can be complex and depends on various factors, including industry-specific regulations and the type of process water being tested. In general, lower HPC counts indicate better water quality and lower microbial contamination. Elevated counts may require further investigation and corrective action.

Heterotrophic Plate Count (HPC) is a valuable tool for assessing the microbial quality of process water in industries where water quality is critical for product quality, safety, and regulatory compliance. Regular monitoring and interpretation of HPC results help ensure that process water meets the necessary quality standards, ultimately safeguarding consumers and the integrity of industrial processes.

"Breathe Easy with Sure-BioChem Laboratories: Understanding Air Quality Testing: Protecting Health in immediate Environments."

Mon, 14 Aug 2023 13:30:00 GMT

With recent air quality alerts due to wildfires and the continuous exposure to invisible airborne particles, understanding air quality and the importance of testing becomes essential.

In this article, we will explore what air quality entails, the factors that contribute to pollutants, the significance of air quality testing, and steps you can take to maintain clean air in your surroundings. Sure-BioChem Laboratory offers air quality analysis services to help you ensure the air you breathe is clean and safe for optimal health.

What is Air quality?

Air quality refers to the cleanliness or pollution level of the air in a specific location at a particular time.

Air quality measurement involves measuring the concentration and distribution of pollutants like particulate matter (PM), nitrogen oxides (NOx), sulfur oxides (SOx), carbon monoxide (CO), volatile organic compounds (VOCs), and ozone (O3). These measurements are compared to air quality standards or guidelines to assess pollution levels and potential health impacts.

Factors that cause Pollutants

Pollutants in the air can arise from various sources, including natural occurrences like volcanic eruptions, dust storms, pollen, and forest fires. Human activities such as industrial emissions, transportation exhaust, residential heating, agriculture practices, and construction also contribute to air pollution. Weather conditions and geographical locations can further influence air quality.

Why Check Air Quality Frequently

Regular air quality testing is crucial for protecting health and evaluating pollution control efforts. By frequently monitoring air quality, you can:

Ensure Health Protection: Regular checks allow you to be aware of potential health risks associated with poor air quality, especially for individuals with respiratory conditions or weakened immune systems.

Gain Awareness and Adaptation: Monitoring air quality helps you understand the quality of the air in your immediate environment. This awareness enables you to adapt your activities and implement measures to protect yourself from harmful pollutants.

Evaluate Mitigation Efforts: Monitoring air quality over time helps assess the effectiveness of pollution control measures. By comparing data before and after implementing interventions, policymakers and communities can refine strategies to improve air quality further.

Necessary Steps to Keep Our Air Clean

To maintain clean air, it is essential to be consistent in monitoring air quality. You can reach out to Sure Bio-Chem Laboratory for air quality analysis services , get a free quote today. Additionally, here are some steps you can take:

Minimize the Use of Pollutant-Emitting Products : Reduce the usage of strong cleaning chemicals, aerosol sprays, and synthetic fragrances that contribute to indoor air pollution.

Ensure Proper Ventilation : Promote airflow and ventilation in your living spaces to remove stagnant or polluted air and bring in fresh air.

Maintain and Clean Appliances: Regularly maintain and clean appliances such as air conditioners, filters, and ventilation systems to prevent the buildup of pollutants.

opt for Eco-Friendly Transportation: Whenever possible, choose eco-friendly transportation options like public transit, biking, or walking to reduce vehicle emissions.

Stay Updated on Air Quality Conditions: Stay informed about air quality conditions in your area by checking local air quality indexes and taking necessary precautions when pollution levels are high.

Regularly checking air quality and understanding its implications are essential for protecting health and creating healthier environments. Sure Bio-Chem Laboratory's air quality testing services , combined with taking necessary steps to maintain clean air, can contribute to your overall well-being. By being aware of air quality in your surroundings, you can make informed decisions, adapt your behaviors, and support pollution control efforts for cleaner and safer air for everyone.

Cleanrooms In Pharmaceutical and Biotechnology: Enabling Precision and Safety in Life Science

Tue, 01 Aug 2023 14:45:00 GMT

Cleanrooms are a fascinating and critical aspect of modern industries that require precise and contamination free environments. These controlled spaces play a pivotal role in various sectors, ranging from pharmaceutical and biotechnology to electronics and aerospace.

In this post, we will delve into the world of cleanrooms in pharmaceutical and biotechnology, exploiting their definition, importance, and the technologies that ensure the highest standards of cleanliness.

What Is a Cleanroom?

At its core, a cleanroom is a controlled carefully engineered space with stringent regulations for minimizing airborne particulates, pollutants and microbial contaminants. They are customized to meet standards specific to the product and the industry.

Cleanrooms are designed to maintain specific cleanliness and temperature conditions, ensuring the production of high-quality products and accurate research results. These spaces are constructed to have limited entry points, specialized air filtration systems, and controlled air pressure differential to prevent the influx of contaminants from the outside environment.

Cleanrooms are classified based on their levels of cleanliness and adherence to specific industry standards. The classification system is defined by the international Organization for Standardization (ISO) denoted by a numeric value. The lower the ISO number, the cleaner the cleanroom. The most common types of cleanrooms are:

ISO Class 1-3: Ultra-Clean Cleanrooms, they have the strictest requirements for cleanliness. These cleanrooms are used in industries that demand extremely low levels of airborne particles, such as semiconductor manufacturing, nanotechnology, and biotechnology research.

ISO Class 4-5 : High-Clean Cleanrooms, they maintain a high level of cleanliness and are employed in industries like pharmaceutical manufacturing, aerospace and advanced electronics assembly.

ISO Class 6-7: Standard-Clean Cleanrooms have slightly relaxed cleanliness standards compared to the higher classes. They find application in industries like medical device manufacturing, automotive assembly and optical components production.

ISO Class 8 : Controlled Environment, they are considered a controlled environment rather than a true cleanroom because they have higher levels of airborne particles but still maintain controlled conditions. They are utilized in industries like food processing, certain research applications, and some aspects of healthcare.

Why is Cleanroom Important

Cleanrooms are indispensable in industries where precision and purity are paramount. They serve as the backbone for critical processes that require meticulous contamination control .

Sterile compounding is a critical aspect of pharmaceuticals, especially in hospital settings and compounding pharmacies. Patients with compromised immune systems rely on customized medications prepared in cleanrooms to avoid infections and adverse reactions.

Biotechnology relies on precise cell culture techniques, where even the smallest impurity can impact research outcomes. Cleanrooms provide the optimal conditions for cultivating cells, microorganisms, and tissues free from contaminants.

Cleanrooms are instrumental in the development of precision medicine, where therapies are tailored to an individual's genetic makeup.

Cleanrooms are critical for assembling spacecraft, satellites, and sensitive military equipment.

Cleanroom helps companies and research institutions comply with stringent industry standards, regulatory guidelines and good manufacturing practices to meet legal requirements and maintaining industry certifications.

Cleanroom ensures that products meet regulatory requirements and customer expectations consistently.

Cleanrooms offer controlled environments that minimize the risk of contamination during manufacturing and research processes.

In a research environment, cleanrooms provide pristine spaces for conducting experiments and studies.

Cleanroom Technologies

High Efficiency particulate air HEPA and Ultra-low Penetration air (ULPA) filters are crucial components in cleanroom ventilation systems. These filters capture and remove airborne particles, ensuring a controlled environment with limited contaminations.

Personnel entering cleanrooms must follow strict gowning procedures, wearing specialized garments and PPE to prevent shedding of contaminants and maintaining a high level of cleanliness.

Cleanrooms are subject to continuous environmental monitoring to ensure compliance with defined cleanliness levels. Regular testing of airborne particles, microbial counts and temperature and humidity control is essential for quality assurance.

In pharmaceuticals and biotechnology, these controlled environments play a pivotal role in drug manufacturing, sterile compounding, advanced cell culture, and groundbreaking research and development. The significance of cleanrooms lies in their ability to create controlled environments that inspire innovation, protect patient health, and elevate the standards of modern medicine. As cleanrooms continue to advance, the future of pharmaceuticals and biotechnology shines brighter, offering a path to safer, more effective, and personalized treatments for patients worldwide.

For companies and institutions seeking reliable cleanroom e nviro nmental monitoring services , Sure BioChem Laboratory is your trusted partner. With our expertise in chemical testing and analysis, we offer comprehensive solutions for cleanroom validation, routine monitoring, and compliance with industry standards.

Routine Environmental Monitoring of Airborne Viable Organisms

Thu, 24 Nov 2022 17:00:00 GMT

Small, invisible things can make a big impact. This is certainly true in the cleanroom setting where even very small mistakes can ruin work, and result in serious illness.

It’s also true in everyday life, where airborne particles that can’t be seen by the naked eye have a true impact on human health.

Environmental monitoring helps identify contaminants, keeping cleanrooms in the state they are supposed to be in while also helping to keep people safe.

In this article, we take a close look at what environmental monitoring systems are, how they work, and why they are important.

What Is Viable Environmental Monitoring?

Viable environmental monitoring helps to understand the level of contamination in a given area.

In the context of this article, we are looking mostly at environmental monitoring for airborne organisms.

This involves air sampling and professional monitoring.

However, environmental monitoring can also happen on surfaces, and other locations to help paint a vivid picture of what factors are at play in a specified area.

Viable Sampling 101

A viable sample contains a living organism—usually something that will grow and multiply over time causing serious issues for cleanroom viability.

It is different from a particle counter in that viability sampling not only counts what is present in a given location but also determines whether or not it is alive. In doing so, it identifies the “viability” of the contamination.

In other words, does this thing that we are looking at pose a threat? How much of a threat?

Viable vs Non-Viable Sampling

As briefly touched on above, viability testing determines how active the threat is. In environmental monitoring, there are ways to count the particle levels in a specified area without actually understanding how actively threatening they are.

In a cleanroom setting you need to hit a specific particle count number—guidelines that can shift considerably depending on the industry.

However, viability testing gives you more information. What are we looking at and will it spread?

Examples of Viable Particles

Viable particles can include anything from mold, yeast, and bacteria to other more benign factors like pollen, dust, etc.

In the cleanroom setting, environmental monitoring—particularly of viable particles—is looking to catch things that can pose a danger to humans if contact is made.

What Is Viable Air Sampling?

Air sampling is done to evaluate the level of viable particles in the air. All of the particles we talked about above can and often are present in the air we breathe.

During everyday life, this is deemed safe at specified levels. When levels exceed the government-approved number , a warning is usually issued for people with sensitive health conditions to stay in.

In the cleanroom setting, air quality standards are much higher. Again, acceptable levels will vary tremendously based on the nature of the cleanroom.

However, you can dependably assume that the contamination threshold in any cleanroom setting will be very low.

How Do We Monitor the Microbial Quality of Air?

So, how is monitoring for microbial quality in the air done?

Various methods can be applied to provide extremely accurate data on the contamination levels of a cleanroom. Below, we highlight some of them.

Methods Used for Enumeration of Microorganisms in Air

There are two types of microbial air monitoring, active and passive. Below, we highlight the difference between the two.

Active Microbial Air Monitoring

With active microbial air monitoring, researchers draw in a specific amount of air and then test it through cultures to measure the level of particles per CFU.

This is often used to specifically determine compliance with standards.

Passive Microbial Air Monitoring

Passive microbial air monitoring evaluates how quickly contamination settles on surfaces. This is performed using “settle plates,” that collect and count sediment.

How Do You Assess Microbial Contamination?

In environmental monitoring, once the contamination has been collected, it is counted. Then it is compared to the standard that is supposed to be upheld.

If microbial intrusion exceeds the allowed amount, then the situation will require further mitigation.

Validating and Qualifying a Clean Room

Air quality monitoring is a routine part of the cleanroom validation process.

The idea is to make sure that the cleanroom always meets the standards it is being held to, thus avoiding dangerous levels of contamination.

Using a Portable Microbial Air Sampler

In environmental monitoring, air samplers are used to quantify contamination.

The idea is to make sure that the airflow in a laboratory setting is not posing a risk to the unidirectional air flow, or the overall health of the environment.

What Is a SAS Air Sampler?

SAS samplers are specifically used in indoor settings to capture and evaluate contamination levels on surfaces.

ISO Air Quality Standards for Clean Rooms

ISO standards are measured on a scale that is classified as ISO3-ISO8. ISO3 is a very strict standard, but the guidelines become laxer as the number advances.

How Often Must a Clean Room be Tested for Compliance With Air Standards?

For environmental monitoring, ISO standards usually require air samples to be taken every twelve months.

Routinely Engage in Air Monitoring and Sampling to Stay Compliant

Air monitoring is an important and routine aspect of maintaining a healthy cleanroom space. It’s easy to do. Contact a qualified professional to learn more about how you can get your air quality evaluated.

Interested in learning more about cleanroom standards? Head on over to our comprehensive guide on Environmental Monitoring Microbiology.

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The Master Guide to Environmental Monitoring Systems and Assessment

Thu, 27 Oct 2022 15:58:00 GMT

In principle, the concept of environmental monitoring is easy to understand. It’s all about looking at a predetermined area and ensuring its conditions are conducive to the desired outcome.

In the pharmaceutical industry, environmental monitoring looks to establish that the practices and procedures being applied to product development are helping to create a safe, sustainable workspace that reduces the risk of microbial intrusion.

A little more complicated, right? That’s ok. In this article, we break it down step by step to explain what environmental monitoring evaluates and how these findings are assessed at a professional level.

What Is Environmental Monitoring and Its Types?

Naturally, many factors contribute to the overall suitability of a work environment. This includes everything from the sanitation habits of the people working in this space, to the air that these people breathe.

Detailed environmental monitoring systems evaluate all of these factors to provide a comprehensive examination of the area in question.

Monitoring The Air

Environmental air monitoring is done to ensure that air conditions are safe for humans. In a community setting, this might mean ensuring air breathability by testing for airborne contamination and pollution.

In the pharmaceutical industry—more on that later on—the specifications become very specific.

Air quality is measured through the air quality index. Often referred to as the AQI, the air quality index runs from 0-500. The instrument works similarly to a thermometer, but instead of measuring temperature, it evaluates contamination levels.

Anything from 0-50 is considered good . From 100-150, the air is considered unhealthy for sensitive groups, and over 200 is considered dangerous for anyone. Major cities tend to have higher scores, with many highly populated areas on the planet having average AQI ratings in the upper 100s.

Monitoring Water

Water is evaluated in environmental monitoring to ensure it is safe for human consumption. This involves looking for potential contamination and making sure that microbial levels don’t exceed the allotted amount.

It’s important to note that water monitoring is not only for drinking water but can also have ecological goals as well. For example, water monitoring might be used to determine if factory runoffs are having an adverse effect on a local natural body of water.

This information, in turn, can contribute to researchers’ understanding of local biodiversity and what kinds of factors contribute to fluctuations.

Monitoring Noise

Environmental monitoring for noise involves making sure that noise levels are not only safe but also reasonably comfortable for human habitation.

It’s important to note that noise monitoring usually happens in a very general way. Noise levels are being taken from all directions and aggregated into an average. Consequently, most environmental monitoring systems that track noise cannot identify the culprit of noise pollution.

At best, noise monitoring technology can narrow down a noisy area, at which point, further investigation is required to pinpoint the source of intolerable noise levels.

The ideal noise level for reducing the odds of noise pollution is 70 decibels or less over a twenty-four-hour period. However, many experts agree that this number may still lead to hearing damage over time.

In any case, overexposure to loud noises can have numerous health risks, including increased chances of heart disease.

Monitoring Biodiversity

Environmental monitoring for biodiversity means making sure that population levels of specific plants and animals within a predetermined area remain stable and healthy.

Fluctuation is natural. However, through environmental monitoring for biodiversity, scientists are better equipped to understand unnatural or otherwise problematic forms of biodiversity reduction. This can include everything from overhunting/harvesting to the introduction of an invasive species with problematic implications. The sooner these factors are identified, the quicker they can be mitigated.

Contrary to popular belief, biodiversity is not necessarily a matter of prioritizing population stability. Animals die out or migrate. Plant species ebb away in certain areas only to reappear in others.

The biodiversity monitoring process itself does not necessarily have an agenda. It’s simply about taking down information. Through these findings, researchers can have better-informed conclusions about what needs to be done.

If, for example, unusual migration patterns in elk are identified due to climate change, little can be done at the local level to make a difference. If, however, this migration is a consequence of deforestation, there may be legislative recourses to explore.

Environmental Monitoring In The Pharmaceutical Industry

Environmental monitoring in the pharmaceutical industry is about consumption rather than habitability. The idea is to monitor and foster conditions that will promote the safe production of pharmaceutical products.

Why It’s Important For Pharmaceuticals

Why does environmental monitoring matter for pharmaceuticals?

The simple answer is that regulatory standards demand it, but the reason they demand it is even more important: regulations are in place to make sure that products are safe for humans to take.

Very small issues—hands that are washed frequently enough or air circulation that isn’t tuned quite right—can have very serious implications for the product itself.

Areas For Environmental Monitoring

Environmental monitoring in the pharmaceutical industry is all about isolating variables and monitoring them appropriately. This includes everything from air monitoring, to personal monitoring and surface monitoring.

Air Monitoring

Air monitoring identifies the acceptable level of CFU particles that are in the air. Professional grade cleanroom standards mandate specific CFU particle intrusion acceptability levels that fluctuate depending on what is being produced.

In almost all cases, however, the acceptable level of CFU presence is significantly lower than what naturally occurs, requiring intricate ventilation and circulation systems to keep air quality high.

Personnel Monitoring

Personnel—the people working in a cleanroom—are perhaps the most unstable variable in the pharmaceutical production process.

While employees are held to extremely high personal hygiene standards, even very minor mistakes can result in significant intrusions at the microbial level.

Employees that work in cleanroom settings are vigorously trained when they are vetted for their position. Often, monitoring practices require the new hire to pass very basic personal hygiene tests before they are even allowed to begin working.

Once they have been hired, they will continue to be routinely evaluated for their hygiene practices. This includes workspace swapping, glove tip tests, and routine training that occurs on an ongoing basis.

While every cleanroom employee is trained vigorously, it takes only a very minor mistake to trigger contamination.

A person forgets to wash their hands. They do wash their hands, but not for long enough. A corner gets cut, a process is forgotten, and before long significant corruption occurs.

Surface Monitoring

In environmental monitoring, surface testing refers to the process of looking at the workstations being used. Surface testing results will be influenced by both the air quality and the behavior of personnel.

What Are Environmental Monitoring Systems?

The environmental monitoring system is a collection of techniques and components that evaluate all of the above-stated conditions. Each system can be varied significantly to meet the needs of the specific situation.

Monitoring Processes

Practically speaking, environmental monitoring involves taking air samples, swabbing work surfaces and the equipment that gets used on them.

It includes evaluating the sanitization held up by personnel through tests that include things like cutting off the tip of their gloves after work has been completed to see what level of contamination is present.

Equipment And Supplies

Environmental monitoring equipment is designed to collect data that will then be evaluated against regulatory standards. This includes lots of swabs and testing solutions, but also physical devices that may be placed in the cleanroom to take constant readings.

Hardware, Software, And Technology

Environmental monitoring tools are powered by various types of technology. This includes hard devices like air quality measurement chambers but can also involve various software programs that track, store, and interpret data.

Data Collection And Collation

Data in environmental monitoring is all about finding out what is in a specified work environment and discovering how this information relates to the regulatory standards that are being upheld.

Environmental Data Assessment

Once the data has been taken and processed it is evaluated against the standards the manufacturer is obligated to withhold.

The findings can be used to invoke penalties and establish the overall suitability of a product, but it is also used to make important decisions on training and other sanitation practices.

Environmental Monitoring Systems In Microbiology

Environmental monitoring systems in microbiology evaluate everything from the facility itself, to the lab, cleanroom, and air that is circulating through the ventilation system.

Facility Monitoring System

Facility monitoring is a broad concept that evaluates the overall microbial levels of a specific area. Data is taken over a long period to establish long-term ranges and averages.

As with all things cleanroom related, the objectives for the facility in question may vary significantly based on the objective.

Some facilities may have relatively loose standards while others can be quite stringent.

Laboratory Monitoring System

Laboratory monitoring systems could include equipment that tracks temperature, CO2 levels, air pressure variances, and other factors that contribute to the overall suitability of the space.

Modern technology allows these readings to be processed in real-time, making it easy to pinpoint intrusions and corruptions as they occur.

Cleanroom Monitoring System

Cleanroom monitoring systems will depend entirely on what is being monitored and what standards must be achieved. Nevertheless, there are consistent pieces of equipment that are used regularly to monitor the suitability of a cleanroom space.

This includes everything from gas monitors and airflow transducers, to portable clean environment tables.

Air Quality Monitoring

Air quality monitoring tests for contaminants, but also uses sensors to detect things like carbon levels, humidity, and general airflow circulation. Depending on what activity the space is being used for, the standards that need to be met can vary pretty tremendously.

For highly sensitive processing and development, contamination levels are very precise, often allowing for under 1000 particles per cubic foot.

For context, a typical uncontrolled indoor environment can easily contain 1.5 million airborne contaminants.

The less sensitive a process is, the laxer the standards become but in all cases, air monitoring for a cleanroom or laboratory condition will need to register particle numbers that are drastically lower than the typical average.

Relative Humidity Monitoring

Relative humidity monitoring refers to the dichotomy between how much water vapor is in the air versus how much is supposed to be there. Excessively high humidity levels can create unsafe work environments while also fostering the growth of bacteria and fungi.

For example, pharmaceuticals are particularly vulnerable to heightened levels of humidity.

Too little humidity can also be problematic, particularly for people. Low levels of humidity inflame nostrils which is why winter is so often associated with nose and throat problems.

Looking To Improve The Environmental Monitoring System At Your Facility?

Environmental monitoring is a complex concept best left to the pros. Professional assistance can help hook you up with a monitoring system that keeps track of your numbers in real time.

Not only does this help you avoid regulatory penalties, but it can also provide you with a highly granular information set that can, when used correctly, better inform your ongoing operations.

Click here to reach out to us today!

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USP 62 Testing and Acceptance Criteria

Tue, 25 Oct 2022 16:00:00 GMT

USP refers to the United States Pharmacopeia—a publication containing modern standards for pharmaceutical testing and manufacturing. USP testing is a set of procedures and guidelines for developing safe, effective products in a highly controlled environment.

Naturally, the standards for pharmaceutical production are extremely high, and failure to follow them to the letter can result in major ramifications both for public safety and the company that has made the mistake.
In this article, we look at USP testing standards and how you can get professional help to evaluate and meet them.

What Is A USP 62?

USP 62 is the professional standard for microbial content on a pharmaceutical sample. It’s designed to ensure that a given sample falls within the acceptable range of microbial occupation.

What Does USP 62 Test For?

The short answer? A lot. The USP 62 testing and guidelines occupy twelve published pages on the USP manual that go into vivid detail about what is being tested for, how the tests are performed, and what must be done.

The longer answer is that it tests for specific microorganisms including but not limited to “Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia species, and Salmonella”.

What Are Microorganisms?

Microorganisms are technically any organisms that can’t be seen by the naked eye, though in this context the phrase refers more specifically to bacteria or fungus particles. USP 62 testing is all about monitoring sample conditions to make sure that there aren’t any dangerous particles present.

How Is USP 62 Testing Done?

USP 62 testing should be performed by experienced professionals. Samples are enriched by a dilutant, (soybean casein digest broth) and then applied to an agar to monitor the presence of objectionable micro-organisms such as those stated above.

USP 62 Acceptance Criteria

When USP testing is done, samples are incubated for three days on various agars, each monitoring for a specific microbial bacteria. The goal is to monitor for microbial growth observed during the incubation period.

If microbial growth is observed, the incubation period is expanded by another two days, after which the microbial levels are recorded, and mitigation is required before the manufacturer can continue.

USP Bioburden Testing

USP Bioburden Testing is related to USP 62 testing, helping to narrow the scientific findings and produce very specific lab results.

What Does Bioburden Mean?

Bioburden refers to the number of living organisms on a sample. This number is derived in the form CFUs (colony-forming units). The desired outcome of a bioburden test is to prove sterility—that’s to say, confirm the absence of microbial intrusion on a sample.

What Is A Bioburden Test?

As described above, a bioburden test counts the number of microbes on a sample. It can also be used in a workspace to ensure cleanroom regulations are being adhered to.

Bioburden Testing Steps

The bioburden testing steps are relatively straightforward. A sample is taken. Microorganisms are then isolated, cultured, and counted. Findings are then distilled into a professional report.

How Do You Calculate Bioburden?

Bioburden findings explain the average number of microbes found in a batch. If three samples are taken, each containing three CFUs, the batch average will be recorded as nine.

What Is Acceptable Bioburden Level?

When it comes to USP 62 testing acceptance criteria there can be a little bit of relativity based on the situation. However, in most cases, the acceptable bioburden level is said to be no higher than ten CFUs.

What Is The Difference Between USP 61 and 62?

USP 62 testing and 61 testing are intrinsically related. USP 62 testing identifies the specific organisms that have to be looked for. USP 61 enumerates those organisms.

What Is USP 61 Testing?

The purpose of USP 61 testing is to determine how much microbial contamination is present in a given sample size.

What Does USP 61 Test For?

USP 61 tests for the total number of microbial contamination levels in a sample or group of samples.

What Is the Difference Between TAMC and TYMC?

TAMC and TYMC are two different forms of microbial intrusion screening . TAMC stands for “total aerobic microbial count.” TYMC stands for “total yeast and mold count.”

The test will depend on the specific requirements of what is being evaluated.

USP 61 Vs USP 62

So, what is the difference between USP 61 and USP 62 testing? It’s not a situation where you do one or the other. Rather both testing standards are applied to any pharmaceutical sample. The idea is to ensure product safety in two ways. First, you isolate specific microbial intrusions to ensure that there is nothing in the sample that doesn’t belong there.

Once you’ve done that, you number the intrusions. If they fall beneath the total allotted CFUs, the sample passes. If they do not, it fails.

USP 62 Testing Services

USP testing standards are complicated but getting it done right isn’t. To properly ensure that microbial levels are suitable, it is important to get professional assistance. Not only does this simplify the process, but it also ensures that you will get a thorough, accurate test.

Interested in going forward with professional support? Click here to receive a USP 62 testing quote now !

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USP 797 Personnel And Surface Testing – Staying Compliant In 2023

Thu, 29 Sep 2022 16:00:00 GMT

USP stands for the United States Pharmacopeia. USP testing is used to monitor sterility conditions. By testing for bioburden and endotoxins. USP 797 standards are typically developed for the purposes of standardizing product quality, making items bought at the store both predictable (the consumer knows what they are getting) and safer.

USP 797 guidelines 2022 can be somewhat difficult for the layperson to understand.

With professional guidance and the right knowledge, it is easy to maintain regulated standards. In this article, we go over everything you need to know about USP 797.

What Is A USP 797?

According to USP , "millions of medications are compounded each year in the US to meet the unique needs of patients." USP 797 is a pharmaceutical standard designed to prevent patient death or harm through lax developmental processes. By monitoring pharmaceutical development USP 797 standards ensure that consumers know exactly what they are getting when they fill out a prescription.

This is accomplished by routinely examining employee behavior, testing equipment, and testing workstations and other often touched surfaces to detect contamination.

Personnel Tests are typically taken at the end of a work cycle. For example, a glove tip test (more on that later) may be performed at the end of the shift, to find out before sanitation processes begin if there is evidence of microbial contamination.

Who Does USP 797 Apply To?

USP 797 applies to everyone involved in compound sterile preparations (CSPs). CSPs refer to all the individuals and locations involved in the development and distribution of pharmaceuticals , including pharmacists, physicians, nurses, and technicians.

All of these people are guided directly by USP 797, beholden to its standards in how they handle and interact with medications destined for patient consumption. Through strict training and careful guideline adherence, these pillars of the healthcare system can help ensure both their own safety and public safety.

What Info Can Be Found In USP 797?

USP 797 sets compounding risk levels based on the odds of contamination. This is done to set guidelines that are specific to the unique circumstances that go into pharmaceutical distribution. USP 797 includes guidance on air quality standards, microbial surface contamination, and human contamination. These factors combine to determine risk levels and guide behavior.

Who Does USP 797 Protect?

USP 797 protects patients and pharmacists alike. The standards pertain to any environments involved in compound sterile preparations. This includes everything from hospitals to retail environments.

Patients get the medication that they need. Pharmacists are guaranteed a work environment with minimal personal risk factors.

USP 797 Risk Levels

At a glance, the risk levels defined by USP 797 are very straightforward: low, medium, and high. The factors that contribute to each risk category can be slightly harder to follow.

Low refers to single-dose sterile ingredients that are not likely to produce notable levels of air contamination.

Medium risk refers to sterile doses that are to be administered either to multiple patients or to one patient multiple times.

High risk involves either non-sterile ingredients or conditions that could involve compromised air quality.

These risk levels are used, in part to establish how often surface and employee testing must be performed. Low-risk environments may only need to perform certain tests on an annual basis, while higher-risk environments will have to do them more often.

USP General Chapter <797> Guidelines

USP 797 outlines policies and procedures that are designed to ensure both drug and patient safety. Though stringent, these rules are there as a safeguard to catch contamination issues at the earliest possible stage.

Provide Routine Staff Training

USP 797 regulations put a big emphasis on staff training for the simple reason that any other standard can be compromised through human error. For these guidelines to truly be effective, everyone working on the staff needs to be on the same page.

A well-trained staff understands how to avoid bringing contaminants into the work environment, while also understanding how to properly sanitize and maintain their stations.

Maintain Personnel Guidelines

Most organizations and labs have their own set of guidelines and standards. Fore example, American Academy of Allergy Asthma & Immunology requires that "all compounding personnel must complete training and be able to demonstrate knowledge of theoretical principles and skills for sterile compounding. Personnel must demonstrate proficiency in these procedures by passing written or electronic testing before being allowed to compound allergenic extract prescription sets."

Many sterility guidelines are straightforward and include relatively simple concepts like using sterile gloves, eliminating personal attire in favor of sterilized garments, making training an ongoing effort, and performing us to make sure that conditions haven’t lapsed.

Though these guidelines are easy to follow, they are often why lapses take place. Employees forget something or cut a corner to expedite a process. Businesses wishing to avoid the big messes that can stem from small mistakes should make training an ongoing priority.

Incoming employees are screened for hygienic competency and required to pass several stages of tests before they can be considered fully onboarded. While this is important, it’s also vital to continue training and refreshing existing employees on ideal practices.

Pay Attention To Facility Design and Maintenance

Of course, staff can only bear so much of the burden. Even strict adherence to 797 guidelines isn’t enough to guarantee lab purity at the microbial level without the right environmental infrastructure.

Air quality and surface cleanliness must be constantly maintained and monitored. Even brief lapses can create conditions that are deemed unsafe. Ideal conditions can only be monitored and maintained through routine testing. It’s important to remember that contamination and lapses can are rarely detectable by the human eye. Testing gives you information that would otherwise be impossible to get on your own.

Monitor Contamination In The Air

Air monitoring is a vital component of maintaining 797 standards—many of which directly hinge on securing certain levels of air purity. Microbial contaminants can easily hang in the air of a room that, by ordinary standards would be considered clean. From a cleanroom standard , however, these conditions are dangerous and unacceptable.

Sample Surfaces For Contamination

Similarly, physical surfaces must also be routinely monitored for contamination . This can be done using periodic tests and contact plates to guarantee that ideal conditions are being maintained.

Because microbial contamination can occur in a split second, routine testing is vital to making sure conditions remain ideal.

Routinely Testing Personnel

As mentioned earlier, people will make mistakes periodically. Errors that would usually be considered minor—using a glove that isn’t properly sterile—can have enormous repercussions based on the strict standards of USP 797.

You can avoid these mistakes by routinely training and testing your staff on proper guidelines. The goal is not to police team members, but to equip them with the training and knowledge they need to keep themselves, and your customers safe.

How Glove Tip Sampling Works

Glove tip sampling tests for fungal and bacterial infection. There is an initial round of testing, for which the ideal results are zero registered contaminants. After that, comes re-evaluation sampling. For this round, media-fill testing has been completed and the standard dictates a reading of <3CFU as the ideal.

Initial Employee Testing

Initial employee testing standardizes competency. Essentially, it’s there to make sure that incoming staff members will be able to complete the necessary hygienic procedures required to maintain 797 standards.

To perform initial employee testing, incoming workers replicate hygienic procedures three times for each hand. The objective is to make sure these employees understand the hygienic process, and that they will have the skills required to execute it every day without fail.

Employee Re-Evaluation Glove Tip Sampling

Employee re-evaluation glove tip sampling takes place immediately following the completion of MFT, but before hand hygiene takes place. This testing is done to further certify the capability of staff members to ensure the safety and sterility of lab conditions.

Glove Tip Sampling Frequency

Following the initial competency evaluation, the standard is to have glove tip testing done at least once every twelve months to make sure that employees are continuing to maintain training and safety procedures.

However, these guidelines fluctuate based on the risk level. In fluctuating conditions sampling may be recommended twice annually, or even more even often depending on the environment.

Additional Glove Tip Sample Testing

Additional testing is necessary to address the potential for failure. Frequent testing is the backbone of clean, sterile conditions, there to ensure that unforeseen circumstances don’t lead to prolonged corruption. The more often you test, the less likely prolific contamination will be.

Periodic Surface Testing

Contamination at the microbial level can happen very easily. It’s important to understand that what 797 considers contamination might well be considered clean or sterile by other standards. Microbial contamination is dangerous partially for the fact that it isn’t visible to the naked eye.

Routine surface testing helps mitigate this risk by ensuring that you always know what, if any conditions are in your lab.

Following Surface Sampling Guidelines

To make sure that testing is done properly, standardized guidelines are there to dictate how and what must be done. By following these standards, labs ensure that their definition of sterility is compliant with that established by USP 797.

Sample Surfaces Post-Compounding And Post-Shift

For surface sampling results to be considered accurate and within the guidelines, the test must take place during a very specific time frame. Evaluations must occur at the very end of compounding activities, but before the area has been disinfected.

The idea here is to make sure that the surface test is evaluating the same conditions that took place during the processing and development.

Sample The PEC Interior

PEC refers to the primary engineering controls—the equipment used to develop pharmaceuticals. Sampling the interior of this equipment is an important component of ensuring that ideal lab conditions are being met and maintained.

Sample Work Areas Near The PEC

Similarly, it’s also important to take routine samples of the staging and work areas that are adjacent to the PEC. These stations are among the most touched places in the lab environment, making them a potential hotbed for contamination.

To that extent, any workstation or “frequently touched area,” should be considered a high priority for routine testing practices.

How Often Is Surface Sampling And Testing Required?

The current surface testing requirements indicate that tests should be done every six months at a minimum. This schedule keeps pharmacies compliant with regulations. However, businesses are free to test more often when they feel they are at higher risk for contamination, or they simply want to make sure that they are covering all of their bases.

Staying 797 compliant is key both to maintaining a safe and healthy work environment, and to making sure that unsafe medications aren’t doled out to the public. To maximize the safety of your lab setting, test as often as you feel is necessary.

Stay Compliant With Routine Personnel and Surface Testing

When it comes to maintaining a compliant lab environment the stakes are pretty high. Remember that contamination can happen at the drop of a hat. When it does, you won’t usually know until after it is already too late.

The more vigilant you are with your testing and training procedures the better prepared you will be to maintain 797 standards.

Staying on top of employee training is one way you can help keep your lab environment safe. Train often and always make sure your staff understands the importance of guideline adherence.

Equally paramount, however, is to stay on top of your testing. Standards indicate annual glove tip testing, and twice annual surface testing to remain compliant. Pharmacies should, at minimum meet these guidelines.

However, you can always test more if you feel there is a risk of contamination, or if you just value being thorough.

Remember that having the right professionals on your side can make your testing procedures go smoother and more effectively.

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What Are The Different Types Of Cleanrooms?

Tue, 27 Sep 2022 16:00:00 GMT

Cleanrooms are manufacturing spaces that must be maintained to a vigorous sanitation standard. There are many industries beholden to cleanroom guidelines: food, pharmaceuticals, cosmetics, and even tech.

The idea is to protect the consumer and the products themselves by maintaining precise, sterile conditions. These guidelines monitor activity at the microbial level, demanding a level of purity that cannot be maintained without the strictest adherence to outlined procedure. In this article, we talk about the various cleanroom types, and how they can be adequately maintained.

Important Factors Of A Cleanroom

Cleanroom standards dictate everything from air quality, to surface contamination. However, humans are ultimately the biggest variable in any production environment. For that reason, cleanroom types always have strict guidelines for human behavior, detailing everything from what they can wear, to how they must sanitize their hands.

Employees working within a cleanroom are routinely trained and evaluated to make sure they are adhering to strict guidelines. Routine competency checks are an important component of making sure everything is as it should be.

Ventilation Methods

Cleanrooms require more than just frequent robust cleanings. As one leading cleanroom manufacturer put it, "clean rooms are classified by how clean the air is." Air filtration must be implemented to keep out airborne contaminants. This is typically done in one of two ways: unidirectional flow and turbulently vented flow.

As the name suggests, unidirectional flow occurs when air currents are moved in a single direction—out of the workspace.

Turbulent (also called non-unidirectional air flow) works by keeping the air in a room in constant motion—thus disrupting microbial contamination particles and sharply reducing the potential for infections. The more the air moves, the harder it is for harmful particles to remain in the workstation. For that reason, cleanrooms usually have more active particles when at rest than they do during productivity phases.

Air Pressure

The desired air pressure in a room will vary based on cleanroom types, between positive and negative pressures. Because every industry has its own criteria to meet, it is very important the correct pressure is being applied. What’s right for one cleanroom could be very wrong for the next.

Air quality classifications (we will get into that more later on) are typically industry-specific. Highly sensitive products require sterile conditions while less delicate, non-consumable items can afford to be lax.

Modular Construction

The construction of a cleanroom is also varied, both by cleanroom types and by your budget. Depending on the circumstances, you can choose between hard wall and soft wall cleanrooms. Hard wall cleanrooms are usually permanent structures, while soft wall is temporary.

Hard Wall Cleanrooms vs Soft Wall Cleanrooms

Because hard wall cleanrooms are permanent, they typically cost more money and are thus favored in the context of long-term projects. Soft wall cleanrooms, on the other hand, can be taken down easily. They are more affordable to build and are often favored in shorter-term projects.

Cleanroom Classes

Cleanroom types are separated both by grade and classification. The standards for each grade and classification can change over time for various reasons. For example, in 2016 ISO standards were "updated to take into account the latest technological developments and market requirements."

Below we break the current classification system down.

Class 1

As American Cleanroom Systems reports, the official Class 1 cleanroom standard is "less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter.”

In simpler terms, this means only Class 1 cleanrooms must maintain near-perfect protection from potential contaminants.

Class 3

Class 3 allows for less than 1000 particles per cubic meter.

Class 5

Class 5 requires no more than 100 particles per cubic meter.

Class 7

A class 7 cleanroom requires fewer than 10,000 particles per cubic foot and allows for no fewer than 60 air changes per hour.

Class 9

Class 9 is the lowest cleanroom standard and can allow for up to 500,000 particles per cubic foot. This standard is applied only in situations where the association between contamination and physical risk is very low.

Cleanroom Classes - A-D

Further classifications come in the form of A-D ratings. These ratings often feature parallel considerations to those listed above but may have additional specifications that must be met as well.

Class A

Class A cleanroom types are used in high-risk scenarios. Here, the airflow is kept at 0.45 m/s at the working position to mitigate the potential risk of harmful contamination.

Class B

Class B has the operative equivalency of Class 7—which is to say that it can allow for fewer than 10,000 particles during active duty. When not in operation, the number of allowable particles shrinks to 3250.

Class C

Class C is one of the more laxer standards, applied to non-consumables like computer chips, that must maintain high cleanliness standards for operational purposes, but not human safety risks.

Here, the standard is that of Class 7—allowing for fewer than 10,000 particles during activity, and 3250 when at rest.

Class D

Class D is what the industry refers to as a non-classified type. That’s to say that there is no particle operational standard. When the room is at rest, Class D rooms adhere to the ISO 8 standard. As with Class C, this is considered a non-critical operational guideline for which issues of human safety are not in play.

Confidently Identify The Different Types Of Cleanrooms!

It’s a lot to take in. Cleanrooms are complicated, both to classify and maintain. Fortunately, there are well-defined guidelines, and professionals there to help make sure they are adhered to.

Vigilance in cleanliness, equipment, and human behavior is required to make sure that cleanroom standards are maintained. All it takes is a minor slip for contamination invisible to the human eye to jeopardize workstations and compromise product development.

With the right guidance, maintaining a good cleanroom can be made simpler. Want to learn more about mastering your cleanroom classifications? Click here to learn more!

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How to Analyze the Shelf Life of Food Products

Wed, 31 Aug 2022 01:23:00 GMT

Everyone has had that moment where they reach into the fridge, frown at the date they find staring back at them from the milk jug, and then make a gamble. Sometimes it works out. Sometimes it really, really doesn’t.

The shelf life of food products is determined for a reason—specifically to avoid getting sick from the things you put in your body. In this article, we are talking about all things related to food shelf life testing. Read on to learn more about how to determine the shelf life of food products.

What is the Shelf Life of Food?

The shelf life of food products refers to the amount of time the food will be both safe and enjoyable to consume. After this data, as with the milk, you may still be ok, or you may wind up with something rotten and horrible on your hands.

There is always a degree of guesswork on the part of the consumer in determining if an item listed as past its expiration date can be consumed safely.

Is Food Good Past The Expiration Date?

The shelf life of food products does not necessarily indicate how long a food item will remain good. Often, a visual or scent-derived inspection of the product will clue you in. The recommendation is usually to dispose of food once it exceeds its expiration date. If you want to take the occasional gamble here and there it’s ok. However, infant formula is an important exception to this. If the container says it is expired, throw it out.

There are several reasons for this. For one thing, babies are much more sensitive to bacteria than adults are. Your infant also lacks the capacity to communicate that their food is spoiled, so it’s completely up to you to make the determination.

How Strict Are Use By Dates?

“Use by” dates typically refer to the peak quality of a product. If the food item in question is not showing visible signs of deterioration (what these are will depend on the food itself) it will probably be safe to consume, even as its freshness might have dipped.

It’s important to keep in mind that even though the dates on food items are determined through rigorous scientific evaluation they are still guesses. Many variables will contribute to how long a food item lasts.

What temperature do you set your refrigerator to? Do you ever leave the door open? How long did it take you to unpack the groceries when you got home from the store? All of these factors add up.

Signs of Spoilage

There are signs that a product has gone bad. Usually, these signs will be specific to the type of food.

Milk may develop a bad smell or (try not to get nauseous) a chunky consistency.

Meat will begin to grey and may develop a slimy exterior texture.

Fish will smell worse than it already did.

When to Toss Leftovers?

Once a food item has been cooked and properly stored, you usually have a little bit longer before it goes bad than you did when it was raw. Always look for signs of spoilage. However, a good rule of thumb is to toss any leftovers after 3-4 days. You’re maintaining a refrigerator, not a museum.

Understanding the Shelf Life of Food Products

The shelf life of food products can be a little tricky for the layperson to understand. Determined by professionals, shelf life can involve a lot of scientific terms. Below, we give a short breakdown of what some of the terms describing the shelf life of food products actually mean.

How to Find the Shelf Life of Food

When trying to determine the shelf life of food products it’s helpful to keep in mind that there are different types of labeling. Always factor in exactly which one you are dealing with.

"Best if Used By/Before"

The “Best if used by” date refers not to a food item’s safety, but rather its overall quality. Usually, it will be ok to use a food item that has exceeded this date, as long as there are no indications of rot or decay.

"Sell-By"

The “sell-by” date is used for inventory management purposes. It is also not a safety classification, though you will want to be on the lookout for signs of rot when a product exceeds this date.

“ Use-By"

Use-by refers to the final day you can use a product and still experience it at peak quality. You may gamble with using a product after this date (except in the case of infant formula) but you are doing so at your own risk.

“Freeze-By”

“Freeze-by” indicates the final date before you can freeze a product and maintain its peek condition. It is not a safety or purchase date, though food items that have exceeded the “freeze-by” milestone will be on the quality decline.

Food Shelf Life Testing

Food undergoes testing before a shelf life is determined. Through this testing, conclusions are made about how long this food will maintain its peak qualities, and about when it will become unsafe to consume.

How is Shelf Life Determined?

The process that goes into determining the shelf life of food products requires a clean lab presided over by experts to complete. To maintain the highest possible standards, this room is required to remain completely free of any contaminants.

Shelf Life Testing Methods

Testing practices may vary from product to product, and, for that matter, from lab to lab. Most products will undergo several different tests to help experts understand how the food item ages both depending on the conditions and context of its storage.

Standard Shelf Life Study

Per Oregon state -the “product is stored at a similar storage temperature and humidity as the distribution environment, changes in the product are evaluated at a specific sampling duration”. In other words, this test is used to explore what happens to a product in the grocery store environment. How does it age while sitting on a shelf?

These conditions can differ significantly from those in the home setting. Grocery store refrigerators get opened more often. The products are handled by more people. How do these variables impact the shelf life?

Accelerated Shelf Life Study

Per Oregon state -The “product is stored at elevated temperature and/or humidity, quality changes in the product are evaluated at a specific sampling rate.” This method can be 2-4x faster than the standard shelf life study, but the calculations produced are just as accurate. This technique is usually implemented as a time-saving measure.

Why Is Shelf Life Testing Important?

Shelf life testing is “designed to provide an objective measure of the quality factors that define the food and the point at which failure occurs. This failure is the point at which the food exhibits physical, chemical, microbiological, or sensory characteristics that are unacceptable to the consumer.”

In other words, the testing is there for your benefit, to make sure you don’t consume food items that will make you sick. Occasionally, food items will expire before the date listed on the label. Usually, however, they become unsafe for consumption a day or two after the date indicated.

Though frustrating to the consumer who may not want to throw out a food item that, by all appearances looks safe (particularly with grocery store prices being what they are) conservative dates are also a safety measure. When it comes to food, it’s always better to throw out a safe product than eat a bad one.

How to Determine the Shelf Life of Food Products

There are a slew of factors that go into determining if a product may be nearing its expiration date. Each of these factors is weighed carefully by scientists who are then able to label the product accurately.

Chemical Composition

Chemical composition can only be determined in the laboratory setting. Once a food item’s chemical structure begins to change it may no longer be safe for human consumption. The actual effects will, of course, vary from product to product. In the case of meats, spoiled food can quite literally be deadly.

When it comes to non-meat products, like grains, it will mostly just be a matter of diminished quality.

In all cases, the chemical change your food product experiences probably won’t do anything to improve it. When high-end retailers refer to “aged cheeses” they aren’t talking about that package of American cheese that has been sitting in the back of your refrigerator since 2017.

Visual Inspection

Not all tests are strictly chemical. Experts also analyze the appearance of a product looking for signs of deterioration. Has the color changed? Are there any indications of mold or fungus? Every food item has its own aging process.

Meats will grey. Breads and cheeses will develop mold. By understanding these signs, scientists are able to indicate not only when a food product will become dangerous but also when the quality will wane.

Odors or Change in Smell

You know it when you smell it, right? Food odor changes over time (and never for the better!). At the scientific level, researchers look for the specific qualities of that change. Does it smell sweet? Sour? A little like vinegar?

The specifics of the smell will indicate exactly what the food product is experiencing.

Physical Deterioration

Not all negative food encounters are as startling as taking a swig from your milk only to find that it has developed a…texture. Sometimes the signs of decay are subtler. Stale bread. Chips that have lost their crispness. Grapes that have begun their wrinkly journey into raisinhood.

Usually, when a product enters a state of physical deterioration, you will know it when you see it. In a pinch, you may be able to squeeze another sandwich or two out of that stale loaf of bread, but most likely you’ve entered a situation of diminishing returns.

It Looks Okay, Smells Fine, But Tastes A Little… Off

We’ve all been there. Your fish (goodness, isn’t it always the fish?) looks fine. The smell is dreadful but this is fish we are talking about. That’s part of the deal. But the taste is ever so slightly…off.

There’s a recipe you can follow to get dinner back on track. Take that fish back into the kitchen, and walk over to the trash can. Throw it away. Time to order a pizza.

Gambles just aren’t worth it. Food poisoning is enormously unpleasant and usually, it’s easy to avoid. Trust yourself. When in doubt, throw it out.

Shelf Life is More Than A Suggestion

Food labels aren’t just a suggestion. They are there to keep you and your family safe. No one wants to throw food away, but sometimes it can’t be helped. If you want to avoid waste, it’s a good idea to go into the grocery store knowing exactly when you will use the food items you intend to buy.

If the label indicates that the chicken in your hand will expire before you can use it, come back to the store on a different and buy it closer to your planned cook. Inconvenient? Maybe. But it beats food poisoning—which, as a reminder, tends to involve gratuitous amounts of diarrhea and vomiting—by a significant margin.

Have food items that need to be analyzed? Don’t wait. Click here to get a free quote.

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What is the Importance of Determining the Shelf Life of a Pharmacy Drug?

Fri, 26 Aug 2022 01:18:00 GMT

Pharmaceuticals, just like any other consumable product will eventually expire. As they age, efficacy declines, and significant safety concerns begin to emerge.

By determining the product's shelf life, manufacturers help ensure that the medicine they produce performs as intended. They also protect the public depending on that medication to stay healthy.

But how can you determine the shelf life of pharmaceutical products? Read on to learn everything you need to know about drug shelf life.

What is Shelf Life?

The shelf life is essentially just the date that a product ceases to be safe for human consumption. Naturally, every product will be a little different in how and when it expires. Shelf lives are generally estimated conservatively to make sure no one heeding the labels still winds up consuming a spoiled product.

Why is it Called Shelf Life?

The simple reason for the term “drug shelf life,” is that it describes the length of time the product can suitably remain on the shelf, either at the pharmacy or at your home.

Does the shelf life of a pharmacy drug really matter?

The drug shelf life definitely matters. As stated above, expiration dates are usually estimated fairly conservatively. This means that it is possible to consume an expired pharmaceutical and not experience any negative consequences.

However, it’s not worth trying. A significant amount of science goes into determining a drug's shelf life. The odds aren’t in the favor of people who decide to ignore those dates.

What happens to medicine when it expires?

When the drug shelf life reaches its end what happens next will depend largely on the product itself. The FDA says that the medicine will be “less effective or risky due to a change in chemical composition or a decrease in strength.”

Can I take medicine that is expired?

You might not get sick from taking something that has reached the end of its drug shelf life. However, it’s important to factor in that the potency will most likely have diminished. If you are depending on medication to regulate (as an example) your blood pressure taking something that has exceeded its drug shelf life could have fatal consequences.

If you are in a bind, consider calling your pharmacist to see what they say.

While you may not want or be able to skip your medication, it’s important to understand the breadth of the situation before taking something you are unsure of.

How is a Shelf Life Found?

Drug shelf life is determined after extensive research by experts in the field. After an intense review of the facts, they select a drug shelf life date that is most conducive to positive healthcare outcomes in the population using the medicine.

How is the expiration date determined?

The process used to determine drug shelf life is called “stability testing.” This process is performed in a cleanroom and used to determine when a drug ceases to be potent or stable (predictable in the results it produces).

What is Stability Testing?

Stability testing is defined as - “Materials are stored at various temperature and humidity conditions and samples are pulled at predetermined time points and subjected to a battery of tests that may include: an identification test, assay, physical tests, microbiological limits, and preservative effectiveness testing, using appropriately validated methods and/or recognized compendial methods”

What Factors Contribute to Determining the Shelf Life

Short answer? Pretty much everything. Long answer. The drug shelf life is influenced by the ingredients and environmental factors relevant to the drug. This includes things like storage conditions, lighting, temperature, and humidity.

Different Medicines Have Different Shelf Life Periods

Each medication will have its own drug shelf life. Never assume that just because you got two medications at the same time they will last equally long. Look for the drug shelf life date, and do any and all research you think is necessary to determine if a medicine is safe.

When in doubt, throw it out

If you’re unsure if a medicine is safe you will usually be better off just throwing it out. However, there are certain situations where you may feel disinclined to do so. For example, many cancer treatment drugs have very short drug shelf life. If you miss a day by accident, it might happen that your final dose would happen on a day outside the drug shelf life.

In situations where there is a potential financial and health-related cost to throwing away medicine, call your pharmacist to review options.

Why is Shelf Life important?

So, to summarize drug shelf life is important because it keeps people safe.

Why Do Drugs Have An Expiration Date?

Chemicals change over time. As they do, the drug changes with them. Consequently, a medication that was safe to take on Monday could be a little different by Friday of that same week.

How to Check The Expiration Date of Medicine

Expiration dates are usually found on the product label, immediately following the abbreviation: EXP. However, sometimes it may be located at the bottom of the bottle.

What Happens When You Take Expired Medicine?

In some situations, the medicine simply won’t work. Depending on your condition, this can be very serious in its own right. Other medications may develop toxic properties post expiration making them even more dangerous to consume.

Should I Take Expired Medicine?

Short answer: usually not. If you are in a situation where you feel it’s necessary, call the pharmacist right away. They can advise you on the decision and tell you what to expect.

Shelf Life is A Big Deal

Here’s the short of it: experts do their research for a reason. Safety should always be the number one concern with any product you take. So, before consuming medication, always take a look at the expiration data, and don’t be afraid to reach out to an expert for clarification.

Need guidance to determine the shelf life of a pharmacy drug? Request a free quote today!

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Top Microbial Contamination Testing Methods

Thu, 28 Jul 2022 13:29:00 GMT

Microbial contamination testing is an important process for which there are many certified methods. When signs of microbial contamination are detected, fast action and dependable methodology are the surest ways to minimize the impact of the problem and get things back on track.

For the layperson, however, much about microbial contamination remains mysterious. How does it happen? What signs should be examined, and, when contamination is detected, what should be done about it?

In this article, we answer those questions and more. Read on to learn about top microbial contamination testing methods

What is Microbial Contamination?

Microbial contamination is the contamination of a product at the microbial level. Clarifying? Maybe not. We’re talking about microbes: tiny particles that are always around us, but too small to be seen without special equipment.

Microbes are a normal, even important part of life. However, for the purposes of research and product development, some standards have to be maintained to ensure both quality and safety.

It’s important to regularly consider top microbial contamination testing methods as a way of ensuring safety and quality.

How Does Contamination Happen?

There are lots of ways contamination can happen. Usually, infiltration comes at the (literal) hands of a small mistake. Someone doesn’t wash their hands for long enough. Someone fails to follow clean room protocol to the letter—a mistake that can be easy to make when one considers just how stringent the requirements are.

Depending on the standards you are being held to, a single speck of dust can be enough to trigger contamination levels at your site. When that happens, you need to get top microbial contamination testing methods right away.

Testing for Contamination

So, just what are the top microbial contamination testing methods? In the headings that follow we will examine this question to help guarantee that you can maintain the safety and sterility of your products.

Risks of Microbial Contamination

The risk of contamination will depend primarily on the type of product you are working with. In food production, for example, innocuous mistakes can result in major health outbreaks. In electronics, even a single speck of dust can render certain products—like microchips—completely useless.

Of course, there is also the potential for penalties from the hands of the government body regulating your production standards. In all cases, it’s best to avoid contamination with regular top microbial contamination testing methods, and other best practices that will keep your production area safe and clean.

Who Needs Microbial Testing?

Anyone who produces things for public consumption will need top microbial contamination testing methods. Additionally, testing will be important for businesses that need to produce products with high levels of accuracy.

Let’s Breakdown the Methods of Microbial Contamination Testing

There are many different types of testing, just as there are many different types of materials that need to be tested. Whatever your industry, you can trust and expect that there is a testing method tailored precisely to your needs.

Why are there various testing methods?

Testing methods will depend on what substance is being tested. These methods will vary based on the purpose of the test.

Water Testing

Assessments of micro-organisms and chemical contaminants in water is a required element of Good Manufacturing Practices. Different kinds of water—deionized, processed, and purified—can all be tested depending on the circumstances. Of course, each type may have its own purity standard that must be met.

Bacterial Testing

Bacterial testing can include things like bioburden, bacterial endotoxin (both medical products), and more. Once again, the substance being tested for will depend both on the product itself, and the standard that needs to be met.

Environmental Monitoring

Environmental monitoring measures and observes various microbial organisms through different surface and air samplers. The idea, of course, is to ensure that the natural environments aren’t being contaminated by human activity or other factors.

Environmental monitoring is an important component of Good Manufacturing Practices.

Microbial Identification

As the phrase suggests, microbial identification is the identification of various microbial particles, both in the environment and on products that are being developed.

Contamination Testing Services

Contamination testing cannot be done on a DIY basis. For proper testing, you need to call a certified testing facility.

Lab Testing for Microbial Contamination

Special machines are implemented to perform microbial contamination testing. These machines are designed to identify even very small levels of contamination to ensure that your product is meeting its regulatory standard requirements.

Testing Standards

Each product has its own standard, measured in PPM—parts per million. During these tests, negative particles are identified and evaluated against the PPM standard that is relevant to the industry or product type.

Lab Testing

Testing is not performed on site. When a testing service is hired, samples will be taken at your location and then brought back to a sterile lab environment for testing and evaluation.

Collecting Samples

Every testing method has its own sample collection technique. However, to the layperson, the process will look mostly similar across the board. The tester takes a swab, and stores it safely in a sterile container, which will be used to transport it to the testing site.

Who Tests for Microbial Contamination

There are many labs that offer microbial contamination testing, but you should only trust high-quality services. Look for professionals who are transparent about their process and will give you a rundown of exactly what they are doing.

Microbial Contamination Testing is A Necessity

Don’t just guess, be sure your products are top notch. Learn more about sterile production and how to avoid microbial contamination with our library of other resources. Not only is testing required to keep your business in good standing, but it’s also just an important part of ensuring that your products are both safe, and able to meet the very high standards that you and the consuming public demand.

Click here to receive a microbial contamination testing quote now!

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The Comprehensive Cleanroom Manufacturing Help Guide

Tue, 31 May 2022 10:15:00 GMT

Cleanroom manufacturing is a vital element of production, adding stability to processes that require an incredible level of precision and accuracy.

An industrial cleanroom prevents contaminants and creates conditions that manufacturers need to produce sensitive equipment.

In this article, we look at what manufacturing for cleanrooms look like, what technology and terminology are involved, and why it is such a vital component of contemporary production.

Read on to learn more about cleanroom technology!

The Importance of Having a Proper Cleanroom Process, Especially for Manufacturing Companies

Cleanroom manufacturing is nuanced and multifaceted.

Many variables contribute to the quality and overall utility of a cleanroom. Moreover, specifications may vary based on industry.

The point, after all, is to provide a sterile, highly controlled environment of production for a specific product.

Below, we explore the nuance and variation that goes into cleanroom manufacturing.

Why does manufacturing need a cleanroom?

To put it simply, cleanrooms exist to ensure the highest possible standard of production.

When it comes to products that are designed for human consumption, it’s assumed that a high standard of cleanliness is baked into the manufacturing and transporting process. However, what that actually means is often an alien concept to the average consumer.

Cleanroom manufacturing is what ensures the quality and safety of a wide range of products.

For manufacturers, it’s there to make sure that nothing compromises the quality of the items that come off the production line.

For consumers, cleanroom manufacturing is there to guarantee a degree of dependability and safety that can’t be achieved without high standards and rigorous sterility practices.

What is Chain of Custody and why is it important?

A product’s chain of custody refers to the unbroken path it takes to get to the consumer's hands.

Documenting this process begins with raw materials, and weaves its way through the various stages of production and transportation.

The process of documenting the chain of custody can be very complex, with links growing into the hundreds for businesses that are exporting products overseas.

Why does it exist? For consumers, the chain of custody regulations are there to ensure a degree of transparency that would otherwise be impossible for supply chain management.

When issues with a product do occur en masse, the chain of custody protocol may be used to identify what the point of corruption was, helping to pinpoint what products are safe, and which ones need to be recalled.

For manufacturers it is equally important, creating internal accountability and providing an easy way to evaluate and critique operational efficiency.

In the event of contamination or damage, the chain of custody protocol makes it easier to identify what went wrong and prevent mistakes from being repeated.

What certifications should I look for when choosing a cleanroom provider?

Cleanroom manufacturing certifications are there to ensure the quality and history of the service you are using. There are many standards and certifications by which a company may establish its credibility.

As you analyze a service, it is always a good idea not only to find out what certifications they have but also what these certifications are saying about the quality of service that you can expect.

For example:

HubZone Certification
Historically Underutilized Business
8(a) Business Development Program Certification
W.O.S.B Certification

Are all some samples of the certifications a cleanroom manufacturing business might have.

Additionally, it’s worth keeping in mind that local ordinances may factor into cleanroom standards, making it worthwhile to find out if the cleanroom manufacturing company you are interested in has been evaluated based on their ability to service your specific community.

Cleanroom Contamination Control and Training

Why is it important to have the best cleanroom contamination control and training standards in place? Cleanroom manufacturing that meets the highest possible industry standards guarantee several things.

Safety for employees: Cleanroom manufacturing standards aren’t just there to protect the quality of a product. They also ensure a stable work environment for employees, eliminating microbiological organisms, and controlling against potentially hazardous conditions that could be dangerous for employees.
Stable Conditions for Equipment: Many pieces of manufacturing equipment require an extreme level of precision. These sensitive tools can be thrown off, or even damaged by dust and other contaminants, resulting not only in costly repairs, but also in manufacturing errors, and disruptions to productivity. Cleanroom manufacturing ensures a high degree of stability that protects sensitive equipment from needless damage.
Consumer Safety: Cleanroom contamination control also ensures consumer safety. The average person assumes that the products they use are safe and dependable. While this assumption is largely accurate, it can exist only thanks to regulations that insist upon the highest level of contamination control. Holding high standards not only protects consumers but also ensures a degree of consistency within a manufacturer's product line, guaranteeing that each and every item on the shelf is as advertised.

Businesses that maintain high standards not only remain industry compliant but also enjoy a reputation for reliability. Consumers may not understand exactly why the products they use are safe and consistent, but they certainly appreciate it.

What’s contamination control?

Contamination control is a generic term that refers to any processes that are in place to eliminate the potential for manufacturing space corruption. Naturally, it means different things depending on the industry.

For a manufacturing company that depends on sensitive equipment, it could mean eliminating dust and moisture in the air.

For businesses producing something destined for human consumption, the focus might be more targeted toward the elimination of bacteria.

In all cases, contamination control depends on establishing stability within a production space.

Thousands of variables in the form of equipment, pollution, and humans exist outside the manufacturing space. Contamination control is there to ensure that the space being used for production remains predictable.

This can only be achieved through high-quality cleanroom manufacturing and a high degree of ongoing training efforts.

Training for Cleanrooms is Key

Cleanroom training is a complex but crucial element of avoiding contamination. Protocol for training cleanroom technicians may vary depending on the goals of the manufacturer. However, training will include information on:

What can be brought into a cleanroom. As the name insists, cleanrooms must be clean. This means that every article introduced to the space is vetted. If something doesn’t need to be there it shouldn’t be. Similarly, any material that does enter a cleanroom should be appropriately sanitized. Training emphasizes what to do.

Material disposal. How often do gloves, masks, etc need to be cycled out? Moreover, what process goes into replacing them? Cleanroom manufacturing training ensures that everyone understands how and when to cycle out protective wearables.

Cleanroom hygiene. Cleanroom hygiene is significantly more stringent than personal hygiene. Well-trained cleanroom technicians understand how to take care of themselves on the job in a way that maintains the purity of their workspace.

Explore Cleanroom Auditing Opportunities

Cleanroom audits take a close look at manufacturing spaces, identifying problem points, and itemizing solutions that are needed to ensure sterility.

Other Industries that Require Cleanrooms

There are many industries that require a heightened level of precision and cleanliness within their manufacturing spaces. In all cases, cleanroom manufacturing is there to guarantee the highest possible level of quality and predictability.

Pharmaceutical

Naturally, the pharmaceutical industry requires an extreme level of precision in its manufacturing process. Cleanroom pharmaceutical standards monitor dust, humidity, temperature, and micro-organism levels to ensure the product is safe and of high quality.

Industrial

Industrial cleanroom standards protect sensitive equipment by monitoring levels of dust and humidity contamination while also emphasizing qualities such as the presence of micro-organisms.

Food Service

Foodservice manufacturers are expected to maintain what is called ISO Class 6 standards. Depending on what they are manufacturing they may be expected to maintain specific humidity, dust, and other contamination levels. These standards may vary slightly depending on what is being produced.

Government Services

Government service cleanroom manufacturing services will vary based on the specifics of the service but are strenuously maintained and reviewed at regular intervals.

Cosmetics

Cleanroom standards are obligatory for a wide range of cosmetic products including but not limited to perfumes, masks, gels, mascara, and concealer.

Additional Aspects to Consider

It’s important to keep in mind that proper cleanroom manufacturing upkeep is a long-term consideration. Short-term expenses and front load training and preparation may seem overwhelming at first.

However, sustainability is the ultimate goal. Your objective is to build processes and infrastructure that will offer your productivity consistent, repeatable protection from contamination.

Below, we examine some further considerations that will help you get the most out of your cleanroom manufacturing infrastructure.

What is the potential cleanroom partner’s reputation?

Like any new hire, reputation is an important consideration to make as you vet between cleanroom manufacturing partners. Does this organization have a proven track record of success?

Moreover, has their previous caseload included companies with needs and operational capacities similar to your own?

As this article has shown, there are many different kinds of cleanrooms. Just because a potential partner has done good work in the past does not necessarily mean they are well-positioned to meet your needs.

What’s the provider’s leadership like?

Think about your business. How does company leadership shape the way the entire organization operates?

Chances are, what the higherups do is paramount to how the entire company runs.

The same will be true of any other cleanroom partner. How a business is run ties naturally into its entire ethos, translating directly into the experiences that potential clients will have.

SBL was founded and run by an African American woman who wasn’t afraid to break down barriers and work hard to provide the highest possible level of service. This determination is palpable in every client interaction.

You should be able to recognize the qualities you want in a partner in the company leadership of the cleanroom manufacturer you are considering.

Do they specialize in cleanroom manufacturing?

Finally, learn about how the company you are considering specializes in your particular needs.

As stated above each industry has its own compliance guidelines that must be carefully followed. A failure to comply can come with significant consequences, both for the quality of your production efforts (think equipment failures and corrupted product batches) and your legal standing.

Businesses that fail to comply with sanitary regulations risk penalties, suspensions, and significant hits in the punitive court of public opinion. You don’t want that, especially not when it can be avoided by making a smart hire. So, study up.

Don’t just look for a good cleanroom partner. Look for someone who is great at fulfilling the specific needs of your organization.

I’m Ready to Find a Cleanroom Manufacturing Partner

So, you’ve learned everything there is to know about cleanroom regulations. You’ve figured out what your business needs are, and how to vet qualified candidates to find someone who is best suited to meet those needs. What comes next?

Now that you know all of that, it’s time to start looking for service quotes. As with anything, it’s important to look for a diverse range of opinions. Speak with 2-5 providers to find out what they would do to meet your needs, and how much it will cost to get the job done. Remember, the lowest bid might not be the best one.

opt for the quote that provides the most bang for your buck. This is a long-term investment that will play an active role in your day-to-day operations.

Get your cleanroom checklist and make sure your business has everything it needs to run as safely and efficiently as possible.

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What You Need to Know About Quality Control Tests for Cosmetics

Thu, 26 May 2022 10:45:00 GMT

Quality control tests for cosmetics ensure that safe products go out into the product.

It’s an important but largely unseen part of the process that goes into determining what finds its way onto store shelves.

The quality inspection that goes into your makeup set has a direct result on your own health, making it important to understand cosmetic product testing.

In this article, we look at cosmetic testing parameters and walk you through everything you need to know about quality control tests for cosmetics.

The Importance of Cosmetic Product Testing

Without quality control tests for cosmetics, substandard products with the potential to be dangerous would find their way onto store shelves.

Control tests are there to establish cosmetic stability, ensuring that the product you buy is safe and what you are expecting.

Who manages cosmetic safety?

Cosmetic companies are responsible for establishing safety and quality control practices that guarantee safe, high-quality products.

Quality control tests for cosmetics are then performed by the FDA to make sure that guidelines have been followed and that products are advertised accurately.

Safety data

The FDA provides safety data to manufacturers.

This information typically describes the safety of specific ingredients, allowing manufacturers to adhere to regulations and industry standards with preexisting information.

Additional testing processes

Quality control tests for cosmetics require additional testing processes as well.

Natural or organic doesn’t mean safe

Organic and natural labels are often misinterpreted.

For one thing, the majority of cosmetics that use the natural or organic label are describing specific ingredients, and not necessarily the finished product itself.

The legal definition allows for a degree of flexibility in how products are labeled.

Buyers that wish to acquire strictly organic products should inspect the label carefully.

They may also wish to look into the manufacturer themselves.

Products that have been labeled organic or natural may still contain chemicals that can be harmful to some consumers.

Types of Cosmetic Product Testing

Quality control tests for cosmetics are multifaceted and there are different types that products might undergo.

Microbiological testing

Microbiological testing for cosmetics identifies the potential for contaminants such as mold.

The tests analyze the risk of microbiological contamination under conditions of normal use.

In other words, will this product become contaminated under ordinary circumstances?

Stability testing

Stability testing investigates how the cosmetic will withstand certain conditions, including exposure to specific moisture and temperature levels.

Toxicological testing

Toxicological testing determines the toxicity of a product and analyzes the conditions for which toxicity would take place.

This could include storage conditions, interactions with other chemicals, or circumstances of the application.

Ostensibly, the idea is to determine if and how a cosmetic can become dangerous.

Performance and cosmetic stability

Performance and stability tests are part of the quality control tests for cosmetics that simulate conditions of actual use.

In a laboratory setting, cosmetics are exposed to temperatures and other control factors that mimic daily use to determine how long a product performs as intended, and what happens during the degradation process.

The top compatibility testing questions with packaging

Compatibility testing with packaging is designed to see how well a product will withstand its container.

Is leakage likely?

Is long-term storage appropriate?

Is there any potential for adverse reactions?

How to Perform a Quality Control Test for Cosmetics

Quality control tests for cosmetics can be performed by following a series of steps described below.

Make your batch

Cosmetic testing starts with making a batch as per the FDA regulations on ingredients.

Fill your samples to test the packaging

Next, the batch is filled with sterilized sample containers that will be used to perform the next several steps.

Take initial readings for pH and viscosity

PH and viscosity levels can be taken using PH strips.

PH balance is important in cosmetics because skin tends to be a high PH surface thanks to exposure to sweat, and other substances that tend to register lower (which is to say more acidic) on the PH scale.

Cosmetics ideally fall into a PH level of around 7.

Higher can pose a threat to skin and hair.

PH should be evaluated based on temperature conditions that are most likely to be encountered during regular storage and use.

Acidity conditions rise with temperature making it an important variable to control for.

Test cosmetics at different temperatures

In addition to establishing acidity, different temperature conditions will also indicate the general stability of a cosmetic.

The idea, as always, is to simulate conditions that products are most likely to encounter during storage, transportation, and everyday use.

Evaluate the final product

Once the tests have been completed, it is time to examine the final product.

If your cosmetic has withstood these tests it may be in market-ready condition.

Other tests, such as microbiological analysis and testing will still be necessary to determine safety, quality, and general suitability.

Confidently Test Your Product’s Quality Today!

Quality control tests for cosmetics are extremely important, both for consumers and manufacturers.

It’s critical to get testing done that is accurate and thorough enough to bring a safe, high-quality product to market.

Testing should be thorough, nuanced, and aligned with the standards and specifications of the FDA.

Remember that cleanroom standards are equally important to the standards of what goes into the product.

Quality control testing is arduous for a reason.

Taking the process seriously is a critical component of playing your part in public safety, maintaining FDA standards, and establishing a rock-solid reputation that will sustain your cosmetic brand for many years to come.

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Breaking Down Bacteria Culture Analysis

Thu, 28 Apr 2022 16:07:00 GMT

Bacteria is common among all walks of life. It’s in the environment, inside us, upon us. Although a large portion of bacteria is harmless, many can cause diseases and illnesses.

So what is a bacteria culture test?

A bacteria culture analysis is used to determine if you have a bacterial infection. It can also help doctors determine the origin of the infection. This then helps them decide the best antibiotics to treat it.

Things to Know Before Taking a Bacteria Culture Test

Primary health care providers may be the ones who directly order a bacteria culture analysis for a patient.

Some of the most common needs for a bacteria test is to check for infections like bronchitis, food poisoning, pneumonia, and many more common ailments.

How does the test work?

In order to begin cultivating bacteria or check for any antibiotic sensitivity, doctors take a small sample of the substance from your body or blood.

The health care specialist then sends the sample to a lab where experts use special tools to help foster microbiological culture. This essentially means they create a controlled environment where the organism can grow so they can sufficiently observe it under a microscope.
Environmental monitoring is one of the most widely-used techniques to observe microbiology.

Types of bacteria culture analysis

There is a large variety of tests that examine different parts of the body based on the potential area of infection.

Applications of bacterial culture tests cover a wide span of ailments.

For example, a blood culture test checks for the potential occurrence of sepsis throughout a person’s entire body. Where a more specific test like sputum culture checks for any potential infection deep in the lungs.

There are many more tests like cerebrospinal fluid culture, stool culture, and throat.

Risks to watch out for

Cleveland Clinic advises that bacteria culture tests have very low risks and most complications are not severe.

Although blood cultures may have a small chance of infection or bleeding because they involve needles. But otherwise, those are natural risks that can be associated with many simple medical procedures.

Methods to Perform Bacteria Culture Analysis

As mentioned before, there are many methods for cultivating bacteria in a test.

Genomic analysis methods are necessary to detect and validate the potential phenotype of a bacteria’s presence.

Despite all the various ways scientists conduct microbiological culture analysis and genomics, they all have the same purpose. Which is to check for food contamination and ensure the safety of food for distribution.

Aerobic v. anaerobic culture

Bacteria that can grow in the presence of oxygen are considered aerobic culture. Of course, scientists still develop controlled environments where the atmospheric conditions are perfect to further multiply the microorganism.

Cultivating bacteria can also happen in environments with low oxygen, such as in deep wounds or in the ocean. This is referred to as anaerobic culture.

Finally, there are also ways to perform a bacteria culture analysis in both environments. This is mostly needed when a bacteria switches from aerobic respiration to fermentation, referred to as facultative anaerobes.

The use of media

Microbiological culture is best observed under the provision of nutrients inside the medium. Scientists typically have a wide selection of formulations they can use depending on the bacteria and microbial monitoring is one of the best techniques used.
The process is explained by Technology Networks , who says that complete media is helpful when trying to get the bacterial cells in good condition. While minimal media just provides the bare necessities so the bacteria can survive, yet have its pathways manipulated by scientists.

Culture both

Culture broth is one of the best ways to exemplify the applications of bacterial culture because of its necessity to check for food contamination.

Culture broth uses liquid media to dilute waste products as the bacteria has access to available nutrients to grow rapidly.

This method is especially helpful for bulking up a microbiological culture in food production or to extract DNA from them afterwards.

Nutrient Agar

Adding agar to a petri dish is helpful to separate specific bacteria from a mixed culture. This is usually common when trying to determine the cause of an infection and any potential antibiotic sensitivity.

Top Applications of Bacterial Culture Analysis

A pure bacterial culture is essential to ensure that strong medicinal products can be produced with no antibiotic sensitivity present.

The National Center for Biotechnology Information expresses how important it is to monitor incubation time, nutrients, atmosphere, temperature, and much more when cultivating bacteria.

It is only when these very specific conditions are met that bacteria culture analysis can really succeed and produce meaningful antibiotics.

Diagnose infection

The most important application of bacterial culture, as mentioned before, is the ability to diagnose infection. Although it may take a while to identify bacterial species, it is still a helpful tool to isolate the presence of a specific pathogen.

Whenever someone may wonder, what is a bacterial culture test, this is the most prominent purpose of one.

Isolating the bacteria will confirm its ability to reproduce. From there, scientists can better determine transmission risks and potential antibiotic sensitivity.
There are many different bacteria out there that can cause infections. Exploring microbial contamination can help you learn more about them.

Develop vaccines and fight pathogens

To fight a potential bacterial pathogen, it’s important to culture the pathogen too. Culturing strains of them to understand their genomes is crucial to develop vaccines that fight viruses.

Scientists may also grow pathogens during bacteria culture analysis and test them on a controlled subject to determine the dosage needed to treat the illness.

If more of the bacteria is needed to fight the vaccine, they would help the microorganism reproduce more until it’s enough to build immunity.

Food production

Of course, the ability to check for food contamination is one of the best applications of bacterial culture.

When it comes to food, bacteria is commonly split into probiotics and starter cultures. Probiotics are cultured for human consumption and tend to be the best choice when producing food.

Maintaining a culture that is free of contaminants is essential for food safety.

Epidemiological study

Cultivating bacteria allows scientists to study how bacterial populations have changed over the years through epidemiological studies. Understanding the history of bacteria helps them determine vaccine remedies, diagnostics, and much more than can help with medical development.

Genetic manipulation

Manipulating the DNA properties of bacteria can help scientists develop vaccine strains and produce specific proteins to help fight illnesses.

Mutating or inserting genetic material is a fundamental aspect of bacteria culture analysis and can help develop a specific strain needed to produce medical products.

Get an Experienced Microbiologist to Perform an Analysis!

As you can see, culture-based genomics is a powerful tool to help understand the nature of various bacteria. Scientists know that there are great advantages and limitations to these techniques and they are actively working to employ all methods efficiently.

Bacteria culture analysis is necessary to detect and determine the viability of bacterial genetics. This, in turn, helps with the production of medicines and vaccines.

These tests also help with determining the cause of a disease of illness in your own body, which doctors can then use to diagnose a treatment.
Bacteria culture and microbiological analysis tests have become one of the most commonly-used, beneficial scientific processes to date!

How Sterility Tests Help Create Vaccines

Tue, 26 Apr 2022 13:15:00 GMT

Sterility, in relation to biology, is defined as something without contamination from microorganisms. Government sterility tests measure sterility in a different way.

A container, medical product, or device is considered sterile when the probability is less than one in a million that microorganisms may reproduce within the product. This is commonly how USP sterility would also be defined.

How Government Sterility Tests Work

So what is a sterility test and how does it work?

It would be extremely tasking to test every vial for a vaccine (for example). Instead, the sterility testing of pharmaceuticals involves creating a large number of samples and testing them during filling.

This means when a few non-sterile samples are found, it is safe to assume that the microorganisms have spread amongst the large set of containers.

A microbiological analysis is also a great process to complement sterility tests to ensure process validations.

Another method that scientists have found to be more helpful is sterility testing methods with broad sensitivity. This involves incubating the samples in growth media where microorganisms can be detected visually as they replicate.

What sterility tests are for

The main purpose of government sterility tests is to prevent the contamination of medical products. This is to ensure the safety of the public and to abide by Good Manufacturing Practices.
According to the World Health Organization , USP sterility guidelines are meant to help with a “wide range of biological medicinal products including vaccines, blood products, biotechnology products, and cell and tissue products.”

Nucleic amplification techniques

Outside of membrane filtration, which we will discuss more in the article, nucleic acid amplification techniques have been one of the greatest advancements in testing.

There are many types of government sterility tests that can detect contamination, but NAT can even screen for viruses.

This newer method, combined with previous detection methods, have a high probability of ensuring pharmaceutical products are free from microbial contamination.

Practical application for medical devices

Direct transfer is one of the many sterility testing methods. But this one in particular works best for medical devices.

Government sterility tests are very practical because they can be used in direct contact with the medical devices during the incubation period to help test for the presence of microorganisms.

The government sterility test workflow

Sterility tests begin with preparation, by placing the membrane filtration device into the pump. Then, sample filtration and rinsing to get rid of any potentially inhibiting compounds.

Then, membrane filtration devices are filled with sterile culture media. Afterwards, it’s the incubation period for 14 days. Final results are determined through a scan for any visual turbidity. Microbial monitoring is a crucial part of any sterility test to ensure that the environment and test samples maintain their immaculacy.

Types of Sterility Tests

Again, USP sterility guidelines and GMP help determine how important it is to confirm that medical products do not contain microorganisms before release.

There are many ways you could test for USP and potentially work with seasoned scientists to ensure products are following standards.

Sterility tests require calculated accuracy because of their use for medical devices, pharmaceutical products, tissue materials, and even vaccines. Government sterility tests were crucial for the development of the Covid-19 vaccine.

Direct inoculation sterility testing

Direct inoculation involves removing a small sample from the medical product and inserting it in a growth medium. This is a place where any microorganisms can grow naturally in a monitored environment, should they be present.

However, only small volumes of the pharmaceutical product can be inoculated, which reduces the reliability of the test.

There are even instances where this sterility testing method can make the sample cloudy, which can make it hard to detect turbidity.

Membrane filtration

When someone may ask: what is a sterility test, membrane filtration is one of the most prominent methods that may come to mind.

Membrane filtration is a filtration process that physically separates molecules of different sizes and properties. It serves as a form of filtration that can be a physical barrier for microorganisms trying to replicate.

It has a lower overall production cost, high flexibility, and delivers high end product quality when it comes to government sterility tests.

Pharmaceutical sterility testing for vaccines

In order to meet the requirements of USP sterility standards, the entire sterilization validation process becomes complex. It is designed to prevent any false positive results.

A detailed guide on USP testing specifications could be helpful before committing to sterility test services.

In cases of vaccinations like the Covid-19 vaccine, it would be tragic if false positives occurred more often than not. This is due to laboratory contamination from the environment or a technical error.

Thankfully, sterility tests have a high success rate and led to the production of the most well-known vaccine to date.
When it comes to sterility testing of pharmaceuticals, Contract Pharma suggests that best practices are to use growth media meticulously to make sure it can support microbial growth. Validation procedures must also be defined early on to ensure the highest quality pharmaceutical products.

The Production of Vaccines

Of course for pharmaceutical products, like vaccines, that are used to medically treat viruses and infections, sterility testing is paramount. In the pharmaceutical industry, cleanrooms are a highly suggested complement to testing because of its sterile environment.

As mentioned before, there are various sterility testing methods that have turned the process into a tedious and artful one. Highly trained laboratory personnel were needed to develop the Covid-19 vaccine in record time amidst an ongoing pandemic.

Sterilization validation

Government sterility tests and sterilization validation is designed to meet the requirements of the United States Pharmacopeia in regards to microbial air and surface counts.

For vaccines, the Validation Test is needed to determine if the sample will inhibit the growth of microorganisms. The aim of a successful sterility test is stasis. Which essentially means that microorganisms cannot grow or replicate within the medical product itself.

mRNA Covid-19 vaccine

One of the most profound technologies used alongside sterility tests for the Covid-19 vaccine is mRNA.

Most vaccines trigger an immune response from bodies by inserting an unactivated version of the virus into the vaccine itself. But the Covid vaccine uses mRNA instead.

The CDC informs us that mRNA created in a laboratory is designed to teach our cells how to make the protein that triggers an immune response on its own. This, in turn, creates antibodies that protect us from the Covid virus.

It is also intended to prevent further infections in the future.

How vaccine development occurs

In the beginning of the pandemic, researchers used a genomic sequencer to recreate the SARS virus. This sequence was shared across the globe to better understand how it caused disease.

From here, scientists analyzed the virus sequence to select the spike protein as their potential vaccine.

The spike protein is designed for a virus to attach to a cell, making it an effective antigen to teach the immune system to recognize and attack the virus if it was present in a body.

Ensuring vaccines are safe for human consumption

To reiterate, government sterility tests’ most significant purpose is to ensure that vaccines are safe for human consumption before release.

There are many different types of vaccines, like bacterial, viral, and DNA-based vaccines.

Regardless of the manufacturing process or raw materials needed, they all must go through a sterility test to make sure that they help the public, not harm them.

Ensure Your Products Can Pass a Sterility Test

Government sterility test procedures are required in many different industries, especially food and cleaning products. But the most important ones are pharmaceutical and medical, where sterility testing is a daily activity for many microbiologists.

So it becomes increasingly important to make sure that you receive sterility tests for your own products! If in any way they are consumed by humans or applied to the skin, there could be risks associated with them if false positives occur.

These risks can be prevented with an expert who knows their way around a viable sterility test!

The USP Testing Specifications Master Guide

Thu, 24 Mar 2022 13:30:00 GMT

USP stands for the United States Pharmacopeia. USP is a non-profit organization that developed standards to test products during development to ensure that they don’t pose a risk to users.

What is USP testing? USP testing specifications include checking for sterility, bioburden, and endotoxin. These predetermined processes are used by a collection of industries in the country.

Some USP testing methods consist of standards that make it universally beneficial to develop safe products. The two most common sterility tests are USP 61 and USP 62, which focus on identifying and calculating any microbial contaminants in the product.

What Are USP Testing Protocols?

Making sure that products are USP compliant isn’t an easy process. It intertwines with different government organizations to ensure that the public is properly protected.

Sure-BioChem labs stays up to date with current USP guidelines , so it may help to learn more about how you can get help with your medical production.

The FDA oversees this process to put medical products through vigorous testing before they are distributed to the public. Content uniformity is one of the biggest tests which involves selecting multiple capsules at random and analyzing them for quality control.

It is an unfortunate reality but sometimes USP testing specifications are illegally avoided by companies or unincorporated distributors. While some of these products may seem safe, the producers are essentially evading scientific testing and these medical products should be avoided.

The USP reference standard is designed to protect us from untested products in the medical world.

How products are examined in the U.S

For medical devices and health-related products, USP 61 and USP 62 are the most common USP testing methods used to examine products during development.

These two methods are very similar, but have some slight differences based on the objective.

USP 61 relates to microbiological enumeration of non-sterile products and tests for contaminants inside a product.

USP 62 is the microbiological examination of non-sterile products. This sterility test specifically tests for the presence of yeast, bacteria, or viruses.

Hiring a team of experts to help with your microbiological analysis could be the right move for lot release testing and product validations.

Combined, these two examination methods ensure that medical products are USP compliant and that no organisms may grow within the item.

Protecting the public

Medical products can be highly volatile and dangerous to the public which is why USP testing specifications are so important.

Essentially, without organizational standard testing, products would be sold without any real proof that they’re safe. It is even more frightening to think that these manufacturers didn’t care enough to test their product, yet are still willing to profit off of it.
Health Europa does emphasize that not every medical product needs to receive FDA approval or be USP compliant, so products without these labels should be used with extreme caution.

USP Medicine Quality Standards

The United States Pharmacopeia includes over 5,000 quality standards for different types of chemical and biological products. USP reference standards observe both active and inactive ingredients.

To reiterate, many products around the world choose to abide by USP medicine quality standards and aim to be USP compliant to increase the odds of customers trusting their products.

Monographs

There are three types of quality standards used for prescription medicine. This includes monographs, general chapters, and material reference standards.

Monographs are documents used to articulate the quality expectations for medical products. They help medicine developers answer the question, “What is USP testing?” Monographs also test for things like identity, strength, and content uniformity.

General chapters provide broad information to each industry on the accepted processes and methods they can use for product development. These chapters apply to innovate, generic, and biosimilar production methods.

Material reference standards are the glue that bridges the first two standards mentioned above. They verify that a medicine and its ingredients meet USP testing specifications.

Key Components

Earlier, we talked about the criteria that monographs typically test for. Again, a monograph is a written document that details the quality standards needed by the FDA.

These are identity, strength, purity, and performance.

Identity is a USP testing specification that ensures that the substance is, indeed, the medicine that it claims to be.

Strength tests for the acceptable ranges of potency approved by the FDA.

Purity works like a sterility test that observes any impurities that may be in a medicine. According to the United States Pharmacopeia , an impurity is any component in the active pharmaceutical ingredients that exceeds a safety threshold for patients.

Performance tests for how the medicine will be released when it enters the human body.

The development process

A monograph usually begins several years before a medicine loses its patent. The license holder of the patent typically works with the USP to develop the monograph and prepare it for revision as well as approval by the FDA.

Types of USP Testing Specifications

USP testing methods vary, but all are designed to determine the safety and benefit of medications. Consumers deserve to know that medical products they purchase meet USP testing specifications and that their health won’t be at risk for using them.

USP 71

USP 71 is a form of sterility testing for medical devices and water. It is possible to produce USP purified water which is directly approved by the organization.

Environmental monitoring is similar to sterility testing because it is used to test conditions for food, water, and sanitation.

There are three methods for implementing USP 71. They include membrane filtration, direct transfer, and product flush.

Nova Biologicals explains how membrane filtration is the most preferred method, which uses the concept that microorganisms will collect onto the surface of the membrane filter. Then, scientists segment and transfer the test fluid to check for incubation time.

If no yeast or mold appears within 14 days then the product will have passed the sterility test.

USP 85

USP 85 is a bacterial endotoxin testing method. The most used test of this kind is the Limulus amebocyte lysate test.

This involved extracting blood cells from a horseshoe crab by the name of Limulus Polyphemus. The LAL reacts with bacterial endotoxin.

The primary purpose of the LAL test is to apply USP reference standards to parenteral pharmaceuticals and medical devices that come into contact with blood.
Bacteria and microbial contamination continue to remain a major threat during the development of medical products. But the LAL test has become a great way to combat this breach in sterility.

USP 2021/2022

USP 2021 and 2022 are mostly used to test for content uniformity within nutritional and dietary supplements as well as water in some cases. This test may also be used to produce USP purified water.

These USP testing methods check for the total number of aerobic bacteria present in nutritional supplements, from raw to completed product. USP testing specifications are typically outlined by the organization in collaboration with the manufacturer.

USP 87, biological reactivity

This test is designed to determine the biological reaction from mammalian cells that come into contact with polymeric materials. Polymeric materials typically include plastic, fiber and polycarbonate.

USP 87 uses various methods to see the biological response of each sample, which can vary depending on the type of polymeric material it comes in contact with.

This test is helpful since medicines are bottled in plastic and come into contact with plastics in hospital settings.

Monograph Testing

Monograph testing is especially helpful for the production of USP purified water. They test things like water for injection, bacteriostatic water, and pure steam.

World Wide Impact from USP

Quality issues affect everyone. It becomes increasingly important to ensure that medicines are USP compliant.

Diseases are beginning to travel faster, drug resistance is growing, and global health issues are on the rise. But USP testing specifications are designed to help curb antimicrobial resistance and protect the people around the world.

A potential superbug through antimicrobial resistance

Antimicrobial resistance causes nearly 700,000 deaths a year, worldwide. It occurs when bacteria begins to adapt to rampant medical treatment and vaccinations. New strains become more difficult to protect against.

Medicine quality is a significant factor for antimicrobial resistance. Medicines with lower doses of active ingredients lead to it.

However, USP testing methods are working to combat this issue through the development of new treatments.

Stopping Covid-19

USP is focused on building society’s trust in the Covid-19 vaccine. USP reference standards are now being developed to ensure the quality of drug ingredients in the finished vaccine.

The organization also offers technical support on issues with vaccine administration and selecting raw materials. USP’s collaboration with public health companies is working to help overcome supply-chain challenges and making sure everyone gets vaccinated.
With the rise of Covid-19, abiding by newly-developed government regulations is important to ensure successful project outcomes.

Reinventing quality standards

The United States Pharmacopeia-National Formulary is a document that houses over 6,800 quality standards for medicine, pharmaceutical ingredients, and much more!

The comprehensive list of USP testing specifications stands as one of the best for quality standards and is used by 150 countries worldwide. Now, they are even integrated into laws in various other countries.

mRNA technology

Since the development of the Covid-19 vaccine, mRNA has become a promising solution towards any potential future pandemics. It is proven that mRNA can also cure other diseases like rabies and the Zika virus.

USP testing specifications are working to address this new understanding and accelerate its development to create more helpful vaccines in the future.

British Pharmacopoeia

So what does BP quality mean? BP stands for British Pharmacopoeia and it is essentially a publication of reference standards used for medical production by Britain. Although there is a difference between USP and BP, they do correlate in many ways.

The BP provides a comprehensive collection of standards for UK pharmaceutical companies to refer to when developing medicinal products.

It helps ensure compliance when companies are involved in pharmaceutical research, development, manufacture, quality control, and analysis.

Reference standards

British Pharmacopoeia chemical reference substances are standards used to compare substances with each other. These unit packs contain materials that are designed for chemical analysis and tested in laboratories to determine the quality of medical products.

What does BP quality mean and how does it work?.

If any drug product is licensed in a country where BP is the legal standard, then the medical product must stay compliant throughout its entire shelf life. No changes in the ingredients should be made without referring to the standards and receiving an updated pass.

Difference between USP and BP

One big difference between USP and BP is that there are a lot of preliminaries listed in the BP standard. Following the BP monograph is actually required from all pharmaceutical companies to completely omit any production of illegal medicine.

The USP has been known to not legally enforce its standards upon all pharmaceutical companies, which is why third party companies are heavily warned against by USP testing specifications.

Although the monographs for both organizations are similar, for the BP all ingredients used within drug substances must comply with the updated BP monograph.

Partnership formation

After the signing of the Memorandum of Understanding in 2019, the current partnership between the USP and BP grew stronger.

Since the agreement, both the USP and BP experienced improved collaboration and shared knowledge between each other about standards for pharmaceutical production and companies. Both the organization and publication were able to update their monographs accordingly.

Their collective work further ensures the quality of medicines that companies must employ through both USP testing specifications and BP standards. The biggest development from the partnership is that both organizations have committed to create opportunities for staff crossover.

This would be for the participation in events and potential joint working ventures.
The European Pharmaceutical Review shares that both organizations believe that the partnership will “better enable [them] to serve the needs of [their] patients and stakeholders across the world and address the future challenges of assuring medicines quality.”

Make Sure Your Pharmaceutical Products Follow Guidelines

As we’ve mentioned, many of the USP testing specifications are enforceable by federal law. The major reason why many countries around the world choose to adopt USP reference standards is because they can help ensure the safety of their medical products.

The various testing methods help check for sterility, biological reactivity, and quality. That is why it’s crucial to make sure your pharmaceutical products follow the appropriate guidelines.

Not only does it keep your company in good standing, but it also takes care of the safety of the public who may use your medical products.

Explore Related Guides

Intro to Cleanroom Requirements for Pharmaceuticals

Tue, 22 Mar 2022 13:30:00 GMT

Cleanrooms are used in a wide variety of industries all around the world. Various types of cleanrooms have specific purposes, but all of them follow strict guidelines to maximize the effectiveness of such complex structures.

What is a cleanroom in pharmaceuticals?

According to PharmTech , “a cleanroom can be defined as an environment where the supply, distribution, and filtration of clean air” are appropriately regulated to meet the standards of government authorities.

In general, cleanrooms are important because they help protect manufactured products from contamination. More specifically, cleanroom requirements for pharmaceuticals are meticulously designed for the commercial survival of a successful product.

So what is the protocol of a cleanroom that ensures the best quality control?

Protocols to Know for Pharmaceutical Cleanrooms

Cleanroom requirements for pharmaceuticals are enforced by the U.S Food and Drug Administration, which publishes the standards for manufacturers and the medical devices they use.

The importance of a cleanroom in pharma is that they have the ability to control humidity, dust, air pressure, microorganisms, and even the temperature. This helps ensure that the products we get for our health, whether it be over-the-counter or prescribed by your doctor, won’t pose a risk to us.

Pharmaceutical products created in a cleanroom are much more meticulously developed and are of the highest standard. Nothing is worse than worrying if the medicine you’re taking could pose a major danger to your health.

It can also help to test your pharmaceutical products beforehand to ensure your cleanroom environment is pure.

That’s why protocols are put into place to mitigate adverse effects of pharmaceutical products!

What is the FDA monitoring system?

There are many dos and don’ts in a cleanroom, but maintaining the air quality is an absolute must.

The monitoring system required by the FDA ensures that pharmaceutical companies test for airborne particles within their labs before, during, and after production.

One of the most well-known aspects of cleanroom requirements for pharmaceuticals is the ISO standard, which determines protocols for air cleanliness, tests, design, operation, and much more.

The cleaner the air, the better

Within the ISO standards, there are specific instructions for maintaining clean air. It must be so specific that pharmaceutical companies must measure the concentration of air particles and ensure they’re within a given threshold.

Every ISO has a predetermined air concentration threshold depending on the class of the cleanroom. For example, a class 8 cleanroom provides air cleanliness levels of a maximum of 100,000 particles per cubic foot.

Although this may sound complex at first, it’s important to know what class works best for a cleanroom in the pharmaceutical industry. A class 8 cleanroom is only one out of an entire ISO range of 1 - 9.

Recommendations for pharmaceutical cleanrooms

Once the class and air quality is determined, there are many protocols needed to maintain high standards during operation.

The FDA also prohibits certain items and activities within a cleanroom. For example, jewelry should not be worn and fast motions should be avoided.

Beyond this, workers should wear special gowns and always interlock the cleanroom doors to maintain air integrity.

Fundamentals of a Cleanroom Design

With something as complex as a cleanroom, the design of such an isolated space can get expensive to build and operate.
Many things must be taken into account such as the level of cleanroom needed, the space, what is the protocol of a cleanroom, and budget. There are many great resources out there to learn more about what’s needed for a cleanroom.

Primary and secondary cleanroom environments

Talk about the layout and equipment used for each of these two classifications

Primary pharmaceutical cleanrooms require advanced engineering equipment and piping layouts that work best with the air quality needed for the class. Next is to observe the key elements of the manufacturing process, which will likely involve offleading, vessel charging, and dispensing.

Secondary cleanroom requirements for pharmaceuticals are structured with a different intent in mind. Instead, the layout is determined by the blueprint and architecture. Then, products and people populate that space in a way where they can still synergize and have efficient traffic flow.

Essentials for a cleanroom layout

The main goal of a cleanroom in the pharmaceutical industry and its layout is to maximize the lower class areas around the main cleanroom suite. This equipment is designed to allow maintenance of the main room from the outside.

Laying out a cleanroom in this way helps minimize costs and maintenance procedures.

Personnel and materials should be kept separate. Entrance and exit routes are also required to be separate to prevent the cross contamination of clothing.

Selecting the right flooring

The greatest cause of contamination in a cleanroom is found on the floor since pollutants tend to travel downward.

Out of many dos and don’ts in a cleanroom, selecting the right flooring is also an important want to ensure compliance with GMP standards.

Pharmaceutical Technology suggests that “the flooring should be resistant to chemicals and solvents, otherwise caustic solutions used for washing the cleanroom can cause damage.”

The flooring shouldn’t have any cracks because bacterial matter could accumulate within them. Finally, the right texture should help reduce the risk of slipping and falling.

Do's and don'ts

Some additional dos and don’ts in a cleanroom include making sure that you remove all jewelry and personal items from your pockets. It is also essential to avoid contamination by coughing or blowing your nose outside of the service area if possible, by quickly exiting before doing so.

A major thing to avoid is wearing cosmetics in the cleanroom. Makeup, eyeliner, aftershaves, and many other chemicals can easily contaminate products. Also avoid touching anything other than the product, which means you shouldn’t even touch your own face while operating in the service area.

Planning Needed for a Cleanroom in Pharmaceuticals

Setting up a cleanroom begins with the design phase. Knowing the importance of a cleanroom in pharma helps understand the purpose of your cleanroom, permitted particle concentration, and its manufacturing process.

Within the industry there are great fluctuations regarding what steps are needed in cleanroom planning, but the cleanroom requirements for pharmaceuticals remains the topic of today.
There are very detailed lists out there that go into deep detail about every step with setting up a cleanroom.

Plan your layout

The biggest thing to keep in mind with planning your layout is the flow of people and materials. A cleanroom in the pharmaceutical industry is an extremely sensitive place, due to the regulations set by the FDA on the medical products.

Hiring a professional from Sure-BioChem Labs could help you determine what government regulations apply to your cleanroom and what class is needed for your process.

The most critical places should have single access points so employees don’t bump into each other. Some pharmaceutical processes could actually contaminate each other, so the layout should keep them separate.

Finally, the finished product should have appropriate outflow routes so they do not come into contact with the creation process again.

Calculate your space pressurization

An important protocol of cleanrooms is ensuring the right space pressurization.

Maintaining a positive airspace keeps contaminants from infiltrating the room. Although it’s impossible to perfectly maintain this positive space pressure, studies show that a very effective pressure differential would be 0.03 to 0.05 in w.g.

Anything above 0.05 in w.g does not provide “better” contamination control. A fine balance is needed.

Determine your remaining variables

Remaining variables include observing the temperature, humidity, electrostatic discharge, and the noise levels of your cleanroom. These are just a few of many additional cleanroom requirements for pharmaceuticals.

Review the potential costs

Of course, costs are one of the biggest factors to consider when creating a cleanroom in pharmaceuticals.

A great practice is to develop a concept study or engineering study to model the potential costs of the cleanroom. Planning the facility specification, size, and layout is crucial to start tallying up the potential prices of these steps.

Get Professional Guidance on Your Pharmaceutical Cleanroom

Review the importance of a cleanroom for pharmaceuticals and explain SBL’s services with cleanrooms and the ability to ensure compliance with the government.

There are clearly many cleanroom requirements for pharmaceuticals that must be taken into consideration. However, knowing these protocols and government regulations are some of the core concepts needed to move forward. Now you know!

A cleanroom in the pharmaceutical industry is a delicate space that cannot be taken lightly. That’s why receiving professional help to calculate costs, review options, and set up your cleanroom could be your best bet.

Sure-Biochem Labs is here to help!

Environmental Monitoring Microbiology Guide

Wed, 23 Feb 2022 21:44:00 GMT

Environmental monitoring is a tool that scientists typically use to better understand environmental conditions, determine its quality, and establish parameters.

This is especially helpful when it comes to quantifying the type of impact an activity has on the environment.

For example, if a pharmaceutical company has established a lab near a national park, environmental monitoring is important to assess what impact this lab has on the environment. This also helps develop policies in order to restrict activities that could have a negative impact on the environment.

Specifically, environmental monitoring microbiology measures the quality of biological presence in the area, like bacteria and organisms.

Data samples are collected and measured over time to determine what changes are happening within the microbial genetics. Upward and downward changes can show the effect an activity has on the environment.

Environmental Monitoring Defined

There are many benefits of environmental monitoring. The main purpose of environmental monitoring is to mitigate the impact a company’s activities may have on the environment.

Environmental monitoring involves checking the soil, atmosphere, and water in an area to enter in an Environmental Data Management System (EDMS). From here, scientists can analyze the consolidated date to create actionable procedures to ensure the safety of the environment.

What is environmental monitoring microbiology?

Environmental monitoring microbiology tests the microbiological quality in a controlled area to see if it’s acceptable. Changes are also monitored over time.

With microbiological testing services and microbiological analysis., scientists will typically use water sample testing, air quality testing , and surfaces testing in a clean area. This helps them understand what type of microorganisms are present to better assess how nearby activities are affecting the environment.

What is an EMP in microbiology?

An environmental monitoring program involves a collection of microbiological testing services that targets biological organisms.

It does not reprimand the problems in an area; instead, it uses data to help people determine if they are following policies, such as food safety plans or pharmaceutical production guidelines.

An environmental monitoring microbiology program is important because it can help find pathogens before contamination happens, determine the effectiveness of sanitation procedures, provide water sample testing, ensure compliance, and much more.

How do you do environmental monitoring?

In general, environmental monitoring techniques involve a combination of measuring air, soil, food and water quality.

For air quality testing, data is gathered using Geographic Information Systems from different sources. Different environmental networks are implemented into various forms of air dispersion, like emissions, meteorological, and topographic. This data is used to detect the presence of any potential air pollutants.

Water sample testing is quite simple. It involves remote sensing techniques to detect the potential presence of chemical, radiological, and microbiological contaminants in the water.

Soil requires gathering multiple samples of composites to check for acidification, microbial genetics, and erosion.

What is environmental monitoring of cleanrooms?

Environmental monitoring of cleanrooms can be an important aspect of pharmaceutical production guidelines . In regard to the production of sterile products and drug substances, ensuring the environment is low risk is crucial.

This involves air quality testing in the cleanroom, to check for the presence of particles or contaminants. The environmental monitoring techniques include looking at disinfectant practices, unusual airflow, physical temperature fluctuations, and staff training.

Learn More: Complete Guide to Mastering Cleanrooms

Top Benefits of Environmental Monitoring Microbiology

There are many benefits of environmental monitoring. The general purpose of environmental monitoring microbiology is to understand if the quality of our environment is getting better or worse.

There are different situations where this is important, but ensuring compliance with government regulations like the CDC is a major one. Risks to wildlife, natural habitats, or even humans are especially restricted by the government in all industries across the board.

The environment

Different environmental monitoring techniques pertain to different industries and locales. Techniques like water sample testing and air quality testing show how environmental monitoring microbiology benefits the environment.

Waste poses a big risk to the environment, through spilt hazardous materials and loss of resources. Waste monitoring is important because it measures the pressure on the environment created by the total amount of generated waste.

The waste intensity, organized by waste category, helps scientists determine how to respond to hazardous materials threatening the environment.

Remote sensing is another technique that monitors the effects of pollutants on large spaces over long periods of time. Understanding these seasonal cycles through Earth observation can help us better respond to the changes in our environment and how microbial genetics react to pollutants.

Food safety

According to the CDC, each year roughly 48 million people get sick and 3,000 die from food-borne illnesses. This is why environmental monitoring microbiology programs are important to help combat the growing issue of food-borne illnesses.

One of the many benefits of environmental monitoring is that it helps verify sanitation programs for foods. It also provides data on what personnel practices and food handling procedures are most proactive. Most significantly, it provides data about spoilage organisms, pathogens, and microbial genetics that cause outbreaks.

A well-known threat amidst food safety is listeria, like the recent "Dole Salad" listeria outbreak in 2022 .

Listeria's a persistent micro bacteria present in soil, water, and decaying vegetation. It can even survive and grow in refrigerated temperatures, a big reason listeria causes about 1,600 food-borne illnesses in the U.S annually.

Pharmaceuticals

Pharmaceutical production guidelines are crucial for companies in this industry and are strictly monitored by the government. Microbiological testing services help test the quality of different pharmaceutical facilities.

Samples are collected from labs, which are followed by isolation and identification. It is known that over 21 bacterial and fungal species can be present in a pharmaceutical if it is not properly tested.
That is why environmental monitoring biology is helpful in order to spot groups of microbial genetics and bacteria like Staphylococci and Bacilli .

What are the Most Common Types of Environmental Monitoring?

The costs of environmental monitoring services depend on the type needed for that situation. When companies prepare an environmental impact assessment (ESA), they are evaluating the negative effects that a future project could have on the environment.

Knowing this can help them determine what microbiological testing services best suit their needs. Some of the different types of monitoring take a look at indicators like pollutants in the air, contaminants, in water, noise, etc.

So what are the types of environmental monitoring?

Air monitoring

Air pollutants are one of the biggest factors affecting human health. Air quality testing can monitor environmental pollutants using sensors and software.

The sensors measure things like nitrogen dioxide, carbon monoxide, and ozone. Air quality is also monitored with stations that collect air particle samples for testing.

Environmental monitoring of water

Considering how much water comprises the Earth’s biomes, environmental monitoring of water is essential to our livelihoods.

This form of testing ensures that bodies of water are clean, sanitary, and safe to drink or use for production which is also important for marine life to exist.

Water sample testing connects sensors deep into oceans, lakes, and ponds to communicate when thresholds are reached. Levels of nitrates, pH, and chemical contamination cannot exceed a limit or else they will be labeled as hazardous to the environment.

Biodiversity environmental monitoring

Biodiversity encompasses the population of various species living on Earth. With climate change becoming more prevalent in our environment, microbiological testing services surrounding biodiversity are needed now more than ever.

Biomonitoring studies how different species react to our effects on the environment. Plants and animals can have adverse reactions to our production processes.

These different species are commonly monitored over a period of time to study how we affect them, especially in regards to our factory production, carbon emissions, and much more.

Environmental monitoring of noise

Noise is monitored on both land and sea. Too much noise can even have negative effects on wildlife. For example, whales cannot communicate with each other if there’s too much noise in their habitat, which could pose a threat to their migration patterns.

Software has been developed to measure real-time noise levels by decibels. Anything that exceeds a certain threshold will have to go through further monitoring to try and determine a solution.

Things like industrial sites, oil rigs, and airports pose a significant threat to the environment through noise pollution.

Biggest Challenges of Environmental Monitoring Microbiology

Environmental monitoring microbiology is complex in nature. Because it includes interval, event-driven data collection to study microbial genetics, it can be a long process.

Sampling occurs in sterilized rooms. Water, product ingredients, and even the air itself can be taken as samples and tested. Workers’ clothing, gloves, and masks must also be tested for bacteria.

Most organizations already have practices in place that are compliant with FDA and CDC standards. However, things can always go wrong when adapting testing intervals. A mistake when investigating a bacterial source could shut down manufacturing lines.

These are some of the biggest challenges of environmental monitoring microbiology.

Inefficient processes

Even when the environmental monitoring techniques are in place, companies still have to focus on reducing cycle times. Data has to be carefully logged into systems to start identifying non-value steps in their process.

The other challenge is that inefficient steps can become very expensive, which is why the cost of environmental monitoring services can be so high.

Teams could duplicate data, spend too long verifying information, or get majorly set back if there is a bacterial break in the area of testing.

Human error

Because of how complex these processes are, they are very error-prone.

Errors in EM can even threaten compliance, impede quality, and slow productivity, which is a big reason why outsourcing can be helpful to mitigate these issues.

Naturally, humans can make mistakes with verifying data, ensuring air quality testing is done properly, and many more potential errors.

Poor collaboration

Working with teams across the globe requires that collaboration is in sync. But if effective communication reports, reliable data, and shared intelligence are not properly shared amongst the team, complications can arise.

Forecasting Environmental Monitoring Costs and Expenses

There is no single price when it comes to determining the cost of environmental monitoring services. You have to remind yourself, what are the types of environmental monitoring?

Because the federal government mandates certain tests depending on your industry, costs can fluctuate. More than one test could dramatically increase the price you pay.

What's factored into the price of environmental monitoring?

In general, the cost of environmental monitoring services can easily exceed $10,000 in a single year, with a small facility.

The factors affecting price include hazard evaluation and determining if an environment has already been exposed to bacteria before production.

Environmental pathogens can also increase costs, because preventative control must be done before setting up the facility.

How frequent specific surfaces must be cleaned is also crucial. Depending on the equipment used, furniture, or tools, some must be cleaned more often than others.

Understanding federal mandates

Again, depending on the amount of federal mandates required for your industry and location, this can increase the costs of environmental monitoring microbiology. Unfortunately, more mandates will up the costs.

How do I develop an environmental monitoring strategy?

One of the most important aspects of developing an environmental monitoring strategy is to do research on the regulations required for your field of work.

Every location has different protocols depending on the facility in development. And once again ask yourself, what are the types of environmental monitoring?

Second is to perform cost planning. Research the size of a lab or location to be tested. This can help you determine what type of surface swabbing must be done, air quality testing, and any other forms of monitoring.

Planning the length of the environmental monitoring is also crucial since changes in microbial genetics must be measured overtime. Knowing the time spent watching environmental changes will help you know what type of microbiological testing service best fits your needs.

A meticulous testing process

With extensive recalls occurring in recent months and growing outbreaks of food bacteria, it’s becoming more important to test for food product contamination. Food testing services can help you stay compliant with the FDA and ensure that your food is safe.

Our team of experienced microbiologists and chemists can perform tests necessary to abide by pharmaceutical production guidelines. Sure-BioChem’s pharma testing services include release testing, product validations, facility tests, and more.

The team of experts can provide you with peace of mind, performing water sample testing to ensure high quality drinking water. Our environmental testing services also include removing dangerous contaminants from water.

Ready to Secure Environmental Monitoring Services?

Again, there are many advantages to environmental monitoring microbiology services.

They have the ability to improve the quality of life for all our society while ensuring our work has a good relationship with the environment.

It takes a highly-trained team and a bulk of software to monitor the data and translate it into actionable insights. This type of work is crucial to advance projects and make sure citizens are informed of changes in the environment in a timely manner.

That is why Sure-BioChem’s team of experts help make the cost of environmental monitoring services worth it!

Simply choose your testing type and provide us with a detailed explanation of the methodology and parameters.

Also Suggested

Ultimate Guide to Mastering Every Cleanroom Classification

Related Learni ng

The Master Guide to Environmental Monitoring Systems and Assessment

Cleanroom Services Checklist

Thu, 17 Feb 2022 15:25:00 GMT

There are many specifications and factors you need to take into account before building a brand new cleanroom.

That's exactly why a checklist is important before you make the investment. Cleanroom services involve a lot of manufacturing, research and development.

First, determine which class, regulation or guideline you must comply with.

Then, be sure to have some type of layout or sketch of your floor plan to properly determine emergency exits, mechanical rooms, etc.

Other important aspects of a cleanroom services checklist include deciding what you will be doing in the room, which ISO class you must comply with, what are the dimensions of the room, and many more.

How Much Does a Cleanroom Cost Per Square Foot?

The price per square foot is important when comparing options because it changes a lot depending on the type of cleanroom services needed.

The price can vary from less than $100 to more than $1,000 per square foot. It’s difficult to give an exact answer because calculations need to be done.

Many companies may even add extras onto the cleanroom to up the price, but take careful consideration into both what you need and what you can afford.

Cleanroom classes are based on the number and size of particles allowed per volume of air.

For example, a Class 10,000 cleanroom would have less than 10,000 particles per cubic foot. With a minimum of 45 to 60 air changes per hour.

Smaller cleanrooms

The bigger the room, the lower the cost per square foot.

With that said, according to ISO 14644-1 cleanroom standards, a class 10 or 100 cleanroom would be considered small. These require larger air changes per minute and filter coverage percentage.

Medium-sized cleanrooms

Medium-sized would be considered a class 1,000 cleanroom which can use less air changes per minute and less filter coverage percentage.
For these cleanroom standards, a cover or aluminum base channel is an appropriate flooring base.

Larger cleanrooms

Larger cleanroom classes are considered class 10,000 and 100,000 - which each use very small air changes per minute and even less filter coverage percentages.
They require modular or drywall coverings and sheet vinyl floor coverings.

What is Required for a Certified Cleanroom?

According to Good Manufacturing Practices, “compliant classrooms require full flush design, covered corners, monitoring systems, airlocks'' and much more (cleanroomtechnology.com).

But there are three most important aspects of a cleanroom.

The first is that the internal surfaces must all be “smooth and impervious”.

The second is the control and quality of the air throughout the room, keeping airborne contaminants out.

The final aspect is the way the cleanroom is operated and the type of staff working in the facility, which must all be taken into account when choosing cleanroom services.

Surfaces

GMP compliance requires that surfaces in a cleanroom don’t create contamination upon themselves.

Meaning, no dust, peeling, flaking of any kind that allows microorganisms to enter the atmosphere.

Surfaces also have to be easy to clean, without any ledges. They are rigid, won’t crease, shatter, or be damaged easily.

Air flow

Cleanrooms require controlled temperature and humidity. This helps mitigate the risk of contamination in the particles.
Particles tend to float around and slowly settle.
Basically, a good cleanroom should provide filtered air that circulates often enough to flush out the particles in the facility.

Employee access

The way a cleanroom operates and the team behind it is extremely important to ensuring the air quality is maintained.
Strictly controlling access of employees in and out of the cleanroom reduces the risk of airborne contaminants.
Most protocols make sure that only trained personnel enter the room, limiting the number. Even trained employees end up being the most significant cause of any contamination.

Understand the Cleanroom Classes and Standards

Cleanroom classes tend to be the most confusing part when choosing from different cleanroom services.

It’s important to understand cleanroom standards so you can figure out which class will work best for your needs.

Learning how cleanrooms are measured by inspectors will help you make an informed decision that’s cost-effective and also within the standards measured by federal agencies.

ISO 14644-1 cleanroom standards

ISO stands for the International Organization for Standardization.

These are essentially formulas that describe the best way of doing something, commonly agreed upon by experts around the world.

Specifically, ISO 14644-1 determines the best practices for air cleanliness in regards to cleanroom services.

Inspectors use light scattering airborne particle counters (LSAPC) to determine the concentration of airborne particles in the air.

Depending on the maximum particles/m3, ISO will determine the type of certified cleanroom needed for the facility.

BS 5295 cleanroom standards

BS 5295 are the cleanroom standards for Britain. These standards have ten classes of environmental cleanliness.
A measurement of the particle size range in the room helps determine which class is needed for specific cleanroom services, ranked from C - M.
The British Standard also identifies three states of operation for a cleanroom:

The first is “as built”, which is a room on completion before employees move in.
The second is “unmanned”, which is operational but not currently in use.
And finally, there’s “manned”, which is in full operational use.

Make Your Cleanroom Services Decision Easy

As you can see, there is a lot to take into account when asking how much does a cleanroom cost.

When creating a checklist, you must think about the class and regulation you have to comply with before determining how much you'd have to pay per square foot.

There are different cleanroom sizes based on ISO standards, ranging from class 10 - 100,000.

Surfaces, air flow, and employee access are three criteria needed to take into account when choosing your cleanroom.

So long as you become somewhat knowledgable about ISO 14644-1 Standards, you will have a clearer picture about what cleanroom will best suit your needs.

But you don’t have to do this alone so get help handling your cleanroom services. Whether it’s testing, monitoring, or classes to understand government standards, find a quality partner that you can trust.

Listeria Outbreak with Dole Salads: What You Need to Know

Thu, 10 Feb 2022 14:00:00 GMT

The CDC has released an alert related to a listeria outbreak in relation to Dole salads products.

The now-recalled salads were reported to have killed two people and sickened 17 others in 13 different states. The salads known to contain listeria are under different brand names, including Ahold, Dole, Kroger, and Marketside.

The CDC suggests that salads with “Best if used by” dates between November 30, 2021 and January 9th should be thrown out.

Treatment for listeria in the fridge would involve cleaning any surfaces inside to prevent the germs from surviving and spreading to other items.

Let's breakdown what exactly is listeria?

What is Listeria?

Listeria is a bacteria that can live in soil, water, dust, food and many other substances. It’s one of the most common causes of food poisoning. This means it can happen to almost anyone unexpectedly.

Listeria is commonly caused by bacteria that grows in cold temperatures, which is why it poses such a high risk for foods in a refrigerator. Unfortunately, there is no way to check for listeria because you can’t taste, see, or smell it.

A way to know how to test for listeria in food is to observe your symptoms after eating something that may have been exposed to the bacteria.

Symptoms of listeria

Signs of a listeria infection typically include diarrhea, muscle aches, fever, and nausea which are commonly associated with general food poisoning. However, symptoms usually pass in a day or two, with plenty of fluids and rest.

Thankfully, the infection does not entirely pose a high risk for most people. But for a rare few, listeria can cause life-threatening reactions, especially for pregnant women, babies, and the elderly.

Understanding treatment for listeria is still important for these groups.

Treatment Plan

The good news is, something as simple as oral antibiotics can help mitigate the effects of a listeria infection. Treatment can vary based on the severity of the infection and potential risks to the specific groups mentioned before.

A visit with your doctor could help if you experience any signs or symptoms of a listeria infection. Some people may be asymptomatic.

So, how soon can you test for listeria and what are the testing options ?

Listeria Testing Options

If you have been exposed to the bacteria, your doctor may begin diagnostic testing, such as a listeria antibody test or blood test.

If the diagnostic does come back positive, IV antibiotics can be a necessary treatment for listeria if your symptoms are more severe. This could hospitalize a person, so their status can be monitored during treatment.

After symptoms end, you may still want to get a listeria antibody test. This test is important because it checks for antibodies in your blood after you have been infected.

If the antibodies are present, then your body will be more prepared to fight off a listeria infection next time it may occur.

The benefits of getting a listeria antibody test will be tremendously helpful for future prevention of the bacteria.

For those looking for lab testing options, check out our expert microbial contamination testing guide.

Preventing Listeria

If you begin to experience symptoms related to food poisoning, it may have been caused by listeria. First, you will want to think back to foods you have recently eaten.

This can include items like soft cheeses or Mexican-style cheeses. Other at-risk food services include raw or unpasteurized milk, and processed meats, such as hot dogs or sandwich meats, and, of course, any food that has been recalled, such as the Dole salads mentioned above.

How to test for listeria in food

Because listeria is undetectable in the food it’s present in, it makes it hard to find. How soon can you test for listeria? There is no easy answer.

The most common tool for listeria testing are swabs and sponges used in a lab.

Labs can usually detect listeria on food samples through a combination of cultural and rapid detection methods. This involves trying to grow the bacteria on the food while rapid detection looks for the DNA of the listeria.

Quality and respected testing labs adhere to a firm chain of custody procedure.

Finding a lab that can perform this careful procedure can be difficult during this outbreak. Luckily, Sure-BioChem Labs knows just how to test for listeria in food!

Explore Your Food Testing Service Options

With the recent recall of Dole salads and other recalls becoming more common, it’s important to be mindful of the potential dangers in your food products.

Sure-BioChem labs can help you with your food testing needs, among many other forms of testing!

Simply determine which type of testing you need and receive a free quote today. There is no cost or obligation to speak with one of our food testing pros today!

The Expert Microbial Contamination Testing Guide

Tue, 18 Jan 2022 13:30:00 GMT

Microorganisms are Both Complicated and Beneficial

We share our world with a host of invisible microorganisms, and our relationship is complicated. Some microorganisms are beneficial to our health, while others can lead to contamination, sickness, and even death. Your company’s greatest defense against harmful pathogens is frequent, consistent microbial contamination testing.

Microbiological testing is a must for any industry wherebiological pathogens could compromise human health. An effective microbiological testing plan will help you swiftly identify contaminants before they causeo irreparable harm to your consumers and your brand integrity.

This guide answers the question: what is microbial contamination testing? We’re here to help you assess your company’s testing needs and find the right testing laboratory to aid with your microbiological analysis strategy .

What is Microbial Contamination?

Microbial contamination is the presence of any unwanted microbes in a material. These microscopic invaders include bacteria, fungi, viruses, yeasts, and protozoan . If contamination occurs, it’s important to identify the offending microbe’s classification. For example, microbiological testing of water could identify Hepatitis A in the public water supply. A lab test for food products could discover a strain of E.coli before the food hits the shelf. This testing data can help you identify the source of the contamination and any inefficiencies in your production chain.

Microbial Testing Defined

What is microbiological testing? Microbial testing methods use biological, biochemical, molecular, or chemical methods to detect or identify microorganisms in a given sample. The depth of your company’s microbiological testing can range from an at-home microbial test kit purchased on Amazon, to extensive analysis performed by a professional testing laboratory.

While microbiological testing can not guarantee 100% product safety, it is a vital part of any company’s environmental monitoring plan. For example, microbial testing is a critical principle in a food production company’s Hazard Analysis Critical Control Point (HACCP) Plan , an internationally recognized system to manage food safety.

The microbial testing methods you require are specific to your company’s needs. Depending on your industry, you may need microbial monitoring to meet desired standards along your production chain, identify risk factors, or comply with industry guidelines and mandates.

Most common examples for needing microbial contamination testing

In reality, everyone can benefit from knowing which microorganisms exist in their living and working space. The type and frequency of microbiological testing you require depends on your industry, your risk factors, and if you are bound to government regulations.

Here is where we most often see a need for microbial contamination testing:

Laboratories and cleanrooms
Medical facilities
Microbial contamination testing in pharmaceuticals
Cosmetics
Facilities with close living quarters such as healthcare facilities and prisons
The entire food supply chain from food production companies to restaurants
Microbiological testing of water

If you’ve determined that your company needs to implement microbial contamination testing, remember that testing should be performed on raw materials, intermediate phases of production, and the finished product. Contact Sure-BioChem Laboratories today to request a microbial testing quote .

What is microbial limits testing?

Microbial limits testing is a comprehensive look at all of the microorganisms that exist within a product.

There are two parts to this testing:

Total number of aerobic organisms (including yeast and mold)
Detection of specific unwanted organisms

Microbial limits testing keeps products in compliance with USP 61 and USP 62 testing procedures.

Top Microbial Testing Methods

When testing for microbial contamination, laboratory technicians work with samples of the product. There are two types of microbiological sampling techniques: destructive and non-destructive. Destructive sampling either destroys or changes the material in such a way that it is no longer fit for service. For example, sample egg products will be compromised after a chemical analysis to detect the presence of Salmonella. Regardless of the microbiological sampling technique that is utilized, sampling is most effective when performed frequently and over multiple sites and time points.

Once samples have been collected, the company follows the chain of custody to submit samples to the testing laboratory. Sure-BioChem Laboratories makes the chain of custody a simple process for your company. Finally, expert laboratory technicians utilize a variety of microbial testing methods such as culture media, immunoassay, and polymerase chain reaction to detect the presence of target microorganisms.

Culture Media

Microbiologists have been using culture media since the 1800 s. This microbial testing method utilizes a special medium composed of different nutrients that encourage microbial growth. Laboratory technicians can then identify, quantify, and differentiate the microorganisms growing in the media.

Laboratories utilize two main types of culture media:

Liquid culture media ( “broth”)
Solid or semi-solid culture media (“agar”)

Depending on the specific applications of the microbial contamination testing, it can take anywhere from twelve hours to more than a week to attain results from culture media testing.

Immunoassay

Immunoassays detect specific molecules by using antibodies to bind to the unique structure of a molecule. Antibodies are the proteins our bodies create in order to fight off foregin molecules, or antigens, in our bodies. The antibodies are highly specific, and will only bind to their target molecule. In the case of microbial contamination testing, the target is the pathogen.

Immunoassays typically yield results in 24-48 hours.

Polymerase Chain Reaction (PCR)

PCR tests use DNA sequences to identify unwanted microorganisms. By repeatedly raising and lowering the temperature of a sample, this technique can produce billions of copies of a DNA sequence. The PCR test then recognizes the DNA unique to the target microorganism.

PCR test results can be generated in as little as a few hours to up to 48 hours.

Most Popular Industries that use Microbial Contamination Testing

If you are wondering if your company should include microbial contamination testing as a part of its safety and quality assurance plan, the answer is probably yes. Any industry that has products, employees, or consumers that could be compromised by harmful microorganisms should have a plan in place for frequent and consistent microbiological testing. This means testing throughout the research, development, manufacturing, and processing phases of development. The time and resources you put into microbial contamination testing will protect your assets and reputation in the long term.

Sure-BioChem Laboratories serves a variety of industries and lab testing type, includings pharmaceuticals , food and beverages , biopharmaceuticals , cosmetics , chemicals, manufacturing , and government .

Microbial contamination test in pharmaceuticals

Microbial contamination testing in pharmaceuticals has a place in every facet of the supply chain: research and development, manufacturing, and putting the final product to market. This is designed to ensure the safety of patients, especially those who are already at risk and more highly susceptible to infection.

Since the pharmaceutical industry requires approval from the Food and Drug Administration (FDA), microbiological testing is a mandate. The FDA ensures that pharmaceutical companies follow United States Pharmaco peia (USP) standards for the identity, quality, purity, strength, packaging and labeling of drug products. In order to achieve these standards, microbiological testing must be conducted on raw materials, finished products and non-sterile products .

Food & beverages

According to the latest estimates published by the CDC , 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases annually in the United States. Microbial contamination happens when a food has been contaminated by microorganisms, including bacteria, viruses, mold, fungi, and toxins. Food contamination and recalls pose a threat to consumer health and safety as well as to the food company’s profits and reputation.

However, food companies can take a responsible, proactive stance against this silent menace. In order to meet FDA standards and ensure the health of consumers, food production companies must carry out frequent, random lab tests for food products all along the supply chain.

BioPharmaceuticals

Biopharmaceuticals are complex medicines made from living organisms. They are produced using innovative biotechnology. Biopharmaceutical products include insulin, human growth hormone, and certain vaccines.

Since biopharmaceuticals are often intended for ill populations, it's especially important to carry out consistent, reliable microbial contamination testing to ensure the integrity of the product. Biopharmaceutical facilities must adhere to current Good Manufacturing Practice regulations for manufacturing, processing, and packaging biopharmaceutical products.

Cosmetics

Cosmetics do not require FDA approval , but companies are legally responsible for making sure their product is safe (10). This includes microbiological safety.

Cosmetics can become contaminated when raw materials are contaminated, manufacturing conditions are unsanitary, or packaging does not protect the product. Frequent microbiological testing at each stage of production is the best way to ensure consumer safety.

Chemicals

Chemicals production is the basis for most of the manufactured products we use every day. Pharmaceuticals, construction materials, pesticides, and green energy are just some of the industries that rely on chemical quality. Microbial contamination testing ensures that microorganisms do not compromise the quality of the chemicals.

Manufacturing

The manufacturing industry is a large umbrella covering any company that produces finished products. This is the end of the production chain, and microbial contamination testing is just as important here as it is in the raw materials stage.

Manufacturers that require microbial contamination testing include textiles, consumer electronics, and fuel. Here are just a few ways that microbiological testing protects these companies’ products and consumers:

Textiles are tested to determine their susceptibility to mildew and rot.
Electronics for HVAC systems and medical devices are tested to ensure they do not support bacterial growth.
Fuel is tested for microbes that will digest and degrade the fuel over time.

Government

Government agencies are at the forefront of research, development, and technology in a variety of fields including military, healthcare, and aerospace. Whether the agency is overseeing the production of a life-saving vaccine or developing new weapons technology, government testing services are necessary to make sure the product is safe before it’s released.

Pricing Review for Microbial Contamination Testing

It’s important to work microbial testing costs into your company's budget. Plan for regular testing, but remember that testing does not give you a 100% guarantee on product safety. You may incur extra microbial testing costs if you experience an unforeseen contamination emergency.

How much does microbial testing cost?

Lab tests for food products can cost anywhere from $100 for basic microbial analysis to over $2000 for a more complex microbiological analysis strategy . A testing laboratory may set a price per individual test, or they may bundle related testing services. While the testing laboratory will serve as your expert in microbial testing methods and procedures, they will only perform the tests you ask for. Be sure to clearly communicate the specific applications you need in order to meet your company’s standards as well as any necessary industry mandates.

Important things to consider when choosing a testing lab

Partnering with a third-party testing laboratory is an efficient and cost-effective way for your company to meet its microbial contamination testing needs. An in-house testing laboratory requires significant space, equipment, and specially trained personnel, and that’s just not a reality for many small companies.

Selecting the right testing laboratory has long term cost benefits and will afford you peace of mind. It’s worth it to do your homework.

Here is a list questions to consider as you interview testing laboratories :

Does the laboratory have ISO/IEC 17025 accreditation , an internationally recognized accreditation standard?
Can the laboratory show that the microbial testing method is properly validated?
Are personnel qualified?
Does the laboratory have the proper equipment and materials for the lab testing types you require?
What microbiological sampling techniques does the laboratory use?
What are the shipping and handling costs for samples?
What is the turn turnaround time for test results?

Your company is ultimately responsible for the testing you request. Clear, consistent communication is the key to a successful partnership with your testing laboratory.

Now You're Ready to Select a Reliable Testing Lab

The best way for any industry to reduce the risk of contamination, product recall, and consumer harm is to execute a thorough microbial contamination testing plan.

By making room in your budget and in your day-to-day operations for a third-party testing laboratory, you set your brand up for long term success.

After reading this guide, you're equipped to pick a high-quality microbiological testing laboratory with reliable testing to help you improve your research and expedite your production.

Ultimate Guide to Mastering Every Cleanroom Classification

Tue, 14 Dec 2021 18:31:00 GMT

Let's Begin with the Cleanroom Basics

Cell phone circuit boards. Skin care products. A car’s air bag. A life-saving vaccine. None of these products could be put to market unless they were manufactured in an efficient cleanroom system.

What is a cleanroom? Cleanrooms are controlled environments used in research and manufacturing settings.

The room is designed and maintained to limit the number of particles per cubic meter of air. If your product could be harmed by contaminants, you will likely need a cleanroom. However, not all cleanrooms are created equally.

The type of cleanroom you require will depend on your industry and how you plan to use your cleanroom.

We're here to help you become well-versed in the best practices for the entire cleanroom experience, especially with the intricacies of cleanroom classifications at each and every level.

This guide is your go-to resource for understanding cleanroom classifications, which will ultimately make you an expert in cleanroom specifications and technology.

Setting the Stage on Cleanroom Classifications

Car parts and electronics both require cleanroom systems to fabricate safe, reliable products. However, electronics that use nanotechnology are far more sensitive to temperature, humidity and static electricity, and require a stricter cleanroom environment.

That’s where cleanroom classifications come into play.

Cleanroom standards are dictated by The International Organization for Standardization (ISO), a collaboration between experts in various fields to maintain agreed-upon standards.

The ISO standards for cleanrooms fall under ISO 14644-1 , which defines nine distinct cleanroom classes according to the number of particles per cubic meter by micrometer size.

The ranking system ranges from ISO 9 (the “dirtiest”) to ISO 1 (the “cleanest”).

An ISO 9 cleanroom is cleaner than a regular room, but the concentration of airborne particulates equates to ordinary room air.

ISO 1 cleanrooms are rare and follow the strictest guidelines.

All cleanrooms follow the same basic principles to protect the products and processes in their space.

What's a cleanroom exactly?

A cleanroom only serves its purpose if it consistently maintains a certain standard of cleanliness. The condition of your cleanroom can mean the difference between product success and failure.

There are three main factors to consider for cleanrooms of any classification: surfaces, air flow, and employee access.

Surfaces | All cleanroom surfaces should be smooth, impervious to microorganisms, and compatible with the approved cleaning agents and disinfectants.
Air Flow | A heating, ventilation, and air conditioning (HVAC) system should regulate temperature and humidity in the cleanroom. HVACs also use high efficiency particulate air (HEPA) filters to remove particles from the space and pressurize the cleanroom. When the air pressure in the room is greater than the pressure outside, the contaminated air is pushed out of the room through vents, filtered, and recirculated. Cleaner cleanrooms require more air exchanges per hour in order to meet classification standards.
Employee Access | Since humans are the biggest culprits for bringing contaminants into a cleanroom, it is essential to train all personnel on cleanroom systems. Employees should know the proper procedures for entering and exiting the cleanroom, protective clothing, and handling equipment. Cleanrooms classified as ISO 8 or cleaner will need airlocks for employees and equipment to transition to and from the space. Cleanrooms should only be cleaned by specially trained personnel using approved cleaning solutions and equipment.

Understand the cleanroom requirements & standards

ISO cleanroom classes provide a blueprint for how a cleanroom should be designed and maintained.

The cleanroom classifications set the maximum allowable particles per volume of air in the cleanroom. Air particles are measured in micrometers or microns. The classification system also recommends the number of air changes per hour each class of cleanroom should maintain.
The chart below displays the ISO 146444-1 cleanroom standards according to the quantity and size of particles per volume of air allowed for each cleanroom classification.

The cleanroom specifications for an ISO 1 cleanroom are extremely rigid.

The cleanroom’s HEPA filters must remove particles smaller than a speck of dust and accommodate 500-750 air changes per hour.

On the other end of the spectrum, an ISO 7 clean room does not take particles smaller than 0.5 microns into account, and only recommends 30-60 air changes per hour.

The types of cleanrooms

Cleanroom manufacturers design many different types of cleanrooms. The cleanroom designs vary depending on the industry, their applications, and ISO cleanroom standards. Some of the variables to consider when deciding on the best type of cleanroom to meet your needs are ventilation methods, air pressure, and modular construction.

Ventilation Methods

Cleanroom air is a top priority for any cleanroom. The two main ventilation methods are unidirectional flow and turbulently vented.
In a unidirectional flow room, high efficiency filters that supply air are placed all along the ceiling or wall. The air flows across the room in a unidirectional way, sweeping away airborne contaminants.
A turbulently vented room uses air diffusers in the ceiling to filter the air. The clean air mixes with the room air, removing contaminants through air extracts in the bottoms of the walls.

Air Pressure

In a positive pressure cleanroom, the product or sample needs to be protected from the outside environment. This type of cleanroom requires a unidirectional flow ventilation method.

In a negative pressure cleanroom, personnel and the cleanroom environment need to be protected from a potentially hazardous sample. Negative pressure cleanrooms utilize exhaust vents to remove dangerous chemicals or powders.

Modular Construction

Many smaller companies choose to pursue modular cleanroom manufacturing as an efficient, cost-effective solution.
The two varieties of modular cleanrooms are hard wall and soft wall.
Hard wall cleanrooms are constructed with rigid walls set between posts. They provide a high level of control over contaminants, static, pressure and humidity, and are well suited for the stricter ISO cleanroom classes.
Soft wall cleanrooms can be made by fabric pulled taut in a frame or plastic strips that hang from a fixture. This option is more affordable and more versatile than a hard wall cleanroom.

The top industries that use cleanrooms

Cleanrooms are often associated with the life sciences and pharmaceutical fields, but cleanroom manufacturing is actually vital to a diverse range of industries.

Pharmaceutical, Biology, and Biotechnology | Organic matter is highly susceptible to contamination and requires a rigid cleanroom environment. The slightest contamination from any unwanted source can lead to inaccurate results and a compromised product. Pharmaceutical cleanrooms and cleanrooms in the life sciences field are most often specified between ISO Class 5 and Class 8.
Government and Military | Government agencies are on the front lines of innovation and new technology. Cleanrooms are necessary for various government projects and experiments. Sure Bio-Chem Laboratories holds SBA HubZone 8A and many other distinct certifications, which makes us an ideal partner for government agencies .
Manufacturing | Certain manufacturing processes require a high level of environmental control in order to maintain the integrity of the product. Manufacturing in a cleanroom environment ensures cleanliness and consistency in production and testing.
Medical Devices | Medical devices are classified based on their risk to the patient . Class I is the lowest risk and includes items such as medical tape and bandages. Class III is the highest risk and includes devices that sustain human life such as pacemakers. Class I and II devices are typically manufactured in ISO 7- 8 cleanrooms, but Class 3 devices require more stringent conditions.
Cosmetics | The cosmetics industry is versatile, utilizing cleanrooms for manufacturing cosmetic products, laboratory analysis, and research and development.
Food Manufacturing | The Food and Drug Administration (FDA) requires that facilities handling food and drugs refer to ISO 14644 for cleanroom construction and maintenance, specifically for maintaining clean air levels with HEPA filters. Cleanroom classifications vary depending on the sensitivity of different food products to contamination, but commonly meet ISO 6 standards.
Electronics | Electronics are sensitive to temperature, humidity, and static electricity. Cleanrooms dedicated to electronics production must be immaculate. You are mostly likely to find Class 1 cleanroom standards for electronics that require nanotechnology.

What's it Like to Work in a Cleanroom?

Working in a cleanroom requires specialized training and attention to detail.

The biggest threat to the cleanroom environment are the humans that enter the space. Cleanroom technicians and other personnel working in a cleanroom risk bringing dust, dirt, microorganisms, and other contaminants into the cleanroom. That’s why employees follow strict protocols for carrying out their work in the cleanroom.

Cleanroom technicians prepare for the cleanroom before they even arrive to work. They must remove accessories such as jewelry, makeup, perfume, eyelash extensions, and nail polish that could compromise the cleanroom. Cleanroom technicians should also shower the day they enter the cleanroom.

Before entering the cleanroom, technicians typically wash their hands, step on a sticky mat to remove debris, and follow specified gowning procedures.

The cleanroom may also come equipped with an airlock chamber, gowning room, or air shower to further decrease the chance of outside contaminants entering the cleanroom environment.

While inside the cleanroom, technicians follow specified protocols to complete their tasks. This includes walking through the room slowly, limited talking, and cleaning the equipment.

When it is time to exit the cleanroom, technicians remove protective clothing in the opposite order it was donned.

Who works in a cleanroom?

The U.S. Bureau of Labor Statistics projects approximately 174,200 openings for assemblers and fabricators each year over the decade.

Advances in technology and automation have reduced the need for unskilled assembly workers.

However, demand remains for skilled assembly workers such as cleanroom technicians. Technicians with cleanroom experience perform complex tasks that machines cannot handle.

Many companies require cleanroom technicians to hold a high school degree or GED and offer on-the-job training.

Cleanroom technicians should be detail oriented and have good manual dexterity to handle intricate cleanroom tasks. Technicians can also pursue certifications to gain cleanroom experience and expertise in this field.

Understand cleanroom air and quality standards

Identifying and controlling sources of contamination

An essential task for cleanroom technicians is monitoring the cleanroom air. Invisible particulate matter such as dust, dirt, dead skin, microorganisms and mold are ticking timebombs in the cleanroom environment.

Your cleanroom requires routine monitoring to ensure it remains in compliance with Good Manufacturing Practice (GMP) standards and ISO 14698-1 standards .

It’s impossible to eliminate all particulate matter from the air. Rather, the goal is to keep particle counts within acceptable standards according to cleanroom specifications.

Positive pressure in cleanrooms helps protect the space from external contaminants by pushing air out of the room to be filtered and recirculated. HVAC systems move air through HEPA filters to remove unwanted particles.

Your ISO cleanroom classification will recommend how many air exchanges per hour are necessary to meet cleanroom requirements.

ISO 14698-1 recommends using active air samplers to monitor cleanroom air. Active air samplers draw in specified volumes of air and quantify the number of microorganisms in the sample. This ensures a consistent and high quality cleanroom environment.

Microorganisms spread easily and can survive in harsh environments, which makes them difficult to control.

The most common type of cleanroom contamination comes from water, air, materials, equipment, the facility, and of course, people.

This video explores the sources of contamination you need to keep on your radar in order to protect your cleanroom environment.

Advanced labs like Sure Bio-Chem Labs offer comprehensive microbial monitoring services pinpoint any sources of contamination so you can gain control of your cleanroom.

The Most Common Misconceptions & Myths About Cleanrooms

Cleanroom classification is a highly specialized system.

When cleanroom manufacturers and workers are not fully versed on the standards and recommendations, they can harbor misconceptions that lead to faulty cleanroom practices.

Misconceptions can also lead you to overcompensate your cleanroom needs, resulting in unnecessary costs and labor.

Here are some common myths about cleanrooms and the realities that result in more efficient cleanroom systems.

Myth : HEPA filters do not work on small particles.

Reality : HEPA filters commonly advertise their efficiency at stopping 99.99% of particles 0.3 microns or larger. However, they also effectively capture smaller particles, including bacteria and viruses.

Myth : Cleanroom air must be kept at low humidity levels to prevent microorganisms from growing.

Reality : Cleanrooms should consistently maintain relative humidity levels of 30%-40% year round. Inconsistent or long term high humidity levels will create problems in your cleanroom.

Myth : Cleanrooms with more airlocks are cleaner.

Reality: While airlocks are effective tools for keeping outside contaminants from entering the cleanroom, their job ends once a human enters the cleanroom environment. It’s up to cleanroom personnel to follow cleanroom protocols correctly and consistently in order to keep the cleanroom clean.

Myth : Anyone can clean a cleanroom.
Reality: Cleanroom maintenance and upkeep is not the place to cut corners. Anyone working in a cleanroom, including the cleaning staff, needs to be thoroughly and consistently trained on specific cleanroom protocol. This includes how to enter and exit the cleanroom, checklists for daily, weekly, and monthly cleaning routines, and approved cleaning solutions and equipment.
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Check out all the myths about cleanroom revealed in this video below:

Cleanroom Installation

Installing a cleanroom is a major commitment of your company’s time, money and resources.

However, if executed thoughtfully, cleanroom installation will be a worthwhile investment in your brand’s integrity. It could save you from product failure, costly recalls, and potential life-threatening consequences for your consumers.

There is no one right way to construct your cleanroom. The cleanroom specifications will depend on your industry, desired applications, and local environment.

What’s important is creating a cleanroom environment that is perfect for your needs and getting it right the first time.

The cleanroom installation process begins with an initial discussion among all stakeholders. Include personnel from production, maintenance, information technology and quality control. Brainstorm everyone’s needs as well as worse-case scenarios to prepare for.

Factoring the installation costs

Now, let’s get to the bottom line. How much will cleanroom installation cost?

Unfortunately, there is no clear cut answer to this question.

Modular cleanrooms can range anywhere from under $100 per square foot to over $1000 per square foot. Cleanroom manufacturers consider many variables when estimating cleanroom installation costs.

ISO cleanroom classification | The lower the cleanroom classification, the cleaner the air needs to be. Efficient cleanroom systems are centered around cleanroom air. Therefore, the HVAC used to treat the air can represent up to half of the cleanroom installation cost.
Space and Environment | How will personnel and equipment enter and exit the room? You will need entrances large enough to accommodate necessary equipment. Does your ISO cleanroom classification require antechambers, gowning rooms, or airlocks? Plan for at least one airlock for any room cleaner than ISO 8. What are the environmental conditions in the winter and summer months? Local weather conditions will impact your cleanroom’s air ventilation system.
Cleanroom Materials | There is a range in costs for doors, windows, and the materials you choose for any horizontal or vertical surface (floors, walls, ceilings). Higher end choices will increase cleanroom installation costs.

Cleanroom manufacturing is just one piece of the budgeting puzzle.

Remember to include the recurring costs for maintaining and monitoring the cleanroom in your cleanroom installation plan.

A cleanroom installation plan includes:

Installing a monitoring system to record the cleanroom conditions.
Creating a plan for daily, weekly, and other periodic cleanings to maintain the specifications of your cleanroom classification.
Staffing trained specialists who use approved cleaning solutions to maintain the cleanroom.
Training all personnel who enter the cleanroom to use best practices.
Monthly energy bills.

Be careful not to overspecify your cleanroom requirements (which could increase your monthly energy bills) or underspecify (which could limit future processes).

The better your cleanroom is constructed from the start, the easier it will be to maintain.

There are many factors to consider, and even small errors can dramatically impact the integrity of your cleanroom.

Partnering with a cleanroom performance testing contractor like Sure-BioChem Labs can help you avoid problems before they occur and help you stay in compliance with ISO standards. Then, you have to ultimately identify weak points in advance so that your cleanroom is fully functional from day one of operation.

Now You've Mastered Cleanrooms - What's Next?

A solid foundation on cleanroom classifications will give you a leg up on your industry’s research and manufacturing capabilities.

The first step is understanding the different types of cleanrooms, and which will work best for your industry and applications.

Once the cleanroom installation is complete, you’ll be able to utilize your cleanroom with confidence knowing the protocols for working in a cleanroom, monitoring your cleanroom air, and eliminating sources of contamination.

Whether you are looking for environmental monitoring of your cleanroom, cleanroom certification, cleanroom air testing, or training your personnel in best cleanroom practices for working in a cleanroom, Sure Bio-Chem Labs offers all the cleanroom services you need to run your cleanroom safely and efficiently.

The Growing Need for Preservative Efficacy Testing

Thu, 19 Nov 2020 12:26:00 GMT

The Growing Need for Preservative Efficacy Testing

The general public expects their pharmaceuticals, cosmetics, and personal care
products to be safe. Antimicrobial preservatives are a key component to maintaining the
integrity of these products. Preservatives inhibit the growth of microorganisms and
extend the shelf-life of the food products, pharmaceuticals, medical devices and
personal care products that people consume on a daily basis. However, there are many
factors that can lead to product contamination such as application methods, packaging
requirements and patient compliance. How can companies assure consumers that their
products are free from microbial contaminants?

Preservative efficacy testing (PET), when conducted by a certified testing laboratory like

Sure Bio-Chem Laboratories (SBL), ensures that the preservatives do their job.
Preservatives must be well-matched to the product’s formula, the specific microbial
threats that thrive there, and the product’s directed use. For example, sterile multi-dose
aqueous products present a greater challenge for its preservatives since there is a risk
of contamination with each use. Picture a child’s cough medicine that is administered
through a syringe attached to the bottle’s cap. The PET confirms that preservatives are
effectively curbing the growth of any bacteria introduced into the product during
manufacturing or consumption, and that those preservatives remain stable over time.

The PET Process

The PET Process begins with the prepared product, preferably in its final container.
The FDA’s Pharmaceutical Microbiology Manual recommends testing a suitable volume
of product—at least 20 mL (1). The product is then challenged with a range of
microorganisms. Scientists take samples at different time intervals, and then perform an
assay to confirm that there is either no increase, or a significant reduction of organisms
over a designated time, depending on the makeup of the product.
PET should be performed when a new product is developed, if the product has been
reformulated, or if there is a change in materials, methods or direct product handling.
SBL provides dependable antimicrobial preservative efficacy testing. We can determine
the validity of antimicrobial preservatives and the level to which they prevent growth of
microbial contaminants in different products that are used on the body. We also test a
microbial assay of antibiotics, using both diffusion and turbidimetric methods. These
processes test for growth inhibition on an agar plate or in media. All these tests are
standardized or tailor-made, depending on the needs of your company.

Regulations

US Pharmacopoeia (USP) lays out clear requirements for the PET of pharmaceutical
products, but regulations for other industries are more vague (2). For example, the Food
and Drug Administration (FDA) states, “Cosmetic products are not expected to be
aseptic; however, they must be completely free of high-virulence microbial pathogens,
and the total number of microorganisms per gram must be low (3).” This is why it is so
important to partner with an experienced testing laboratory like SBL. Our team is well
versed in USP regulations, and even if there is no current standard for your product, we
have the prior experience necessary to create a new procedure that will establish
preservative efficacy for your individual needs.

References:

1. https://www.fda.gov/media/88801/download
2. https://www.usp.org/
3. http://www.fda.gov/downloads/cosmetics/guidanceregulation/guidancedocuments
/ucm208412.pdf

The Contamination of Drinking Water: Concerns for Children in School Systems

Wed, 28 Feb 2018 00:00:00 GMT

The current probability of exposure to water provided by funded agencies and intended for human consumption containing toxic agents is an ever-growing controversy at present. These contaminants come in many forms, from microbial pathogens to heavy metals. Water contamination may be measured depending on the nature of the toxin. In cases involving non-biological (e.g. non-organic) threats, odds ratios incorporating the distance of residence or occupation from the source of contamination may be reported1. Microbiological pathogens may be measured using typical techniques such as qPCR2. The type of contaminant may also influence how the phenomenon of ‘poisoned water’ affects the individual. It may result in cases of enteric disease (e.g. norovirus-related gastroenteritis) or in long-term detriments in general health and function1-3. This is thought to be particularly severe when a younger person is exposed to contaminated water1. The age of an individual may influence the probability of exposure to contaminated drinking water. For example, a study of over 400 households who had experienced an urban public supply contamination event found that those with younger members consumed significantly more water during this crisis compared to those with older members4.Children may be exposed to water-based or –borne toxins at their respective schools. This may be due to past federal requirements that free drinking water be made available in public schools at lunchtimes5. A national survey indicated that up to 89% of children attended compliant schools, the majority of which used pre-existing drinking fountains and public dispensers5. Approximately 25% of these children reported perceptions of water quality issues associated with drinking fountains5. A model of the lead exposure prior to remediation in over 60 Seattle and 600 Los Angeles schools found that up to 31% of students were estimated to risk unsafe blood lead levels (5μg/dL or more) in un-modified schools6. School grounds are subject to a range of variables that are thought to influence the risk of toxins, as are all common human environments. These include changes in the ambient temperature due to weather conditions and the probability of stagnation. The regular disinfection of water (and plumbing systems) being conveyed into, or within, school-based water transport systems also influence the development of microbiological contamination. The plumbing itself is also a viable factor in the environmental contamination within schools. This concerns the materials of which water pipes are composed (as brought to light as part of the current Michigan-based public health situation) and also the level of maintenance that prevents the formation of biofilms on their inner surfaces2. A biofilm may support a toxic concentration of a certain pathogen. Its development is (again) affected by stagnation and local temperature1. Some health authorities and researchers argue that a proportion of microbial contamination may be prevented through improved control of the conditions in which water is stored or circulated2. For the purposes of this, water intended to be provided from hot taps should be maintained at 140ºF or hotter, and water from cold taps (or that intended to be potable) should be kept at 68ºF or lower7. These are relatively simple programs that, in combination with consistent circulation, may prevent the spread of pathogens such as Legionella and Naegleria fowleri8. However, this does not take potential issues such as the budget and resources available to the average public school into account. Some school districts resort to simpler measures such as first-draw flushing rather than pipe replacement to reduce exposure to lead6. In general, children may be at risk of pathogen- or toxin-related disease due to drinking water at U.S. schools. This is an under-studied and under-documented area of public health and epidemiology. In the current climate where there's increased attention and scrutiny on prospective microbial and toxin-related contamination events, waiting for such an incident is a risk that most schools and institutions can't afford. Frequently testing drinking water supplies at schools and institutions proactively helps to mitigate the risk of future contamination events. Current state and federal laws and require the water-based testing of these institutions completed by certified testing organizations like Sure-BioChem Laboratories. Our certified and experienced team can help ensure that your school or institution is prepared for any contamination events in your water supply. For a free consultation contact us at 888-398-7247 or visit us at surebiochem.com References: 1. Garcia-Perez J, Morales-Piga A, Gomez-Barroso D, et al. Risk of neuroblastoma and residential proximity to industrial and urban sites: A case-control study. Environment international. 2016;92-93:269-275. 2. Ashbolt NJ. Microbial Contamination of Drinking Water and Human Health from Community Water Systems. Current environmental health reports. 2015;2(1):95-106. 3. Matthews JE, Dickey BW, Miller RD, et al. The epidemiology of published norovirus outbreaks: a review of risk factors associated with attack rate and genogroup. Epidemiology and infection. 2012;140(7):1161-1172. 4. Schade CP, Wright N, Gupta R, Latif DA, Jha A, Robinson J. Self-reported household impacts of large-scale chemical contamination of the public water supply, Charleston, West Virginia, USA. PloS one. 2015;10(5):e0126744. 5. Hood NE, Turner L, Colabianchi N, Chaloupka FJ, Johnston LD. Availability of drinking water in US public school cafeterias. Journal of the Academy of Nutrition and Dietetics. 2014;114(9):1389-1395. 6. Triantafyllidou S, Le T, Gallagher D, Edwards M. Reduced risk estimations after remediation of lead (Pb) in drinking water at two US school districts. The Science of the total environment. 2014;466-467:1011-1021. 7. Sidari FP, III, Stout JE, Duda S, Grubb D, Neuner A. Maintaining Legionella control in building water systems. Journal - American Water Works Association. 2014;106(10):24-32. 8. Codony F, Perez LM, Adrados B, Agusti G, Fittipaldi M, Morato J. Amoeba-related health risk in drinking water systems: could monitoring of amoebae be a complementary approach to current quality control strategies? Future microbiology. 2012;7(1):25-31.

From Health Problems to Product Recalls, Poor Air Quality is the Culprit

Wed, 20 Dec 2017 00:00:00 GMT

Indoor air quality reductions are often induced by a wide array of factors corresponding to living (biotic) and non-living (abiotic) factors. In many instances these biotic and abiotic factors amalgamate to create issues that are greater than the sum of the individual factors acting alone. Nowhere is this more evident than in the environmentally induced growth of mold in inconsistently cooled and dehumidified indoor environments. In many industries, central heating and cooling systems are the essential component of maintaining a viable production, manufacturing and working environment. However, these central heating and cooling systems are often expensive to install and require extensive maintenance schedules that often go unfulfilled [3]. As such, a growing number of businesses, as a cost saving measure, are returning to the use of decentralized heating, ventilating and air conditioning systems (HVAC) that only effectively and reliably work within an area of few feet from the HVAC systems [3,4]. Implementation of such systems often results in a higher prevalence of stagnant air conditions in areas that are far removed from the decentralized HVAC [1]. During the colder months, having an increased prevalence of stagnant air conditions poses no significant biotic threat to the building or the employees, as most microbes are cold intolerant [2]. However, these stagnant air conditions in the colder months do bring with them a greater propensity of decreased air quality conditions [1]. The World Health Organization (WHO) categorizes businesses and buildings being affected by decreased air quality standards as having “sick building syndrome” [5]. Sick Building Syndrome (SBS) is defined as “an excess of work-related irritations of the skin and mucous membranes and other symptoms, including headache, fatigue and difficulty concentrating caused by poor air quality standards, in modern office buildings” [4,5]. In the warmer months, the effects of these poorly maintained centralized HVAC systems or their decentralized counterparts often results in increased humidity and temperature within the workspace. Increases in humidity and temperature provides the perfect breeding ground from fungal growth and subsequent possible fungal sporulation events [3,5]. These sporulation events, compounded with the higher incidences of abiotic PM2.5 particulates leaching into workplaces during the warmer months, significantly reduce both the air quality and the prospective health of employees in that environment [2]. The combinatorial effect of these biotic fungal growth events and the abiotic PM2.5 leaching into the building often results in many adverse health conditions like coughing, wheezing, skin and eye irritation, cardiovascular stress and cancer in chronic cases [5]. Within the medical, biotech and pharmaceutical industries where sterility and quality assurance is critical to production, having these biotic fungal sporulation and abiotic PM2.5 events severely affecting indoor air quality can be a cause avoidable product recalls and audits that can consequently hinder future production efforts [5]. Organizations like the World Health Organization (WHO), the Environmental Protection Agency (EPA) and the Centers for Disease Control (CDC) advise having a verifiable standard of air quality and microbial burden testing year-round [3,5]. Having your workspace and products certifiably accredited for sterility by a verified laboratory like Sure-BioChem Laboratories goes a long way to protecting your employees, customers and your investment. Sure-BioChem Laboratories specializes in providing testing and certification that is industry and federally approved. Our experienced team specializes in testing for particle counts, HEPA filter integrity testing, airflow volume/velocity, establishing fungal detection protocols, temperature and year-round microbiological monitoring. For more information regarding your air quality testing contact Sure-BioChem Laboratories for your microbial monitoring consultation today at 888-398-7247. Sources: 1. Bomberg, Mark, and Fred Andreas. "The energy conundrum of modern buildings." Frontiers of Architectural Research 2.4 (2013): 500-502. 2. Maddalena, R., et al. "Effects of ventilation rate per person and per floor area on perceived air quality, sick building syndrome symptoms, and decision?making."Indoor air 25.4 (2015): 362-370. 3. Rocha, C. A., et al. "Characterization of Indoor Air Bioaerosols in an Electrical Headquarter Building." Indoor and Built Environment 22.6 (2013): 910-919. 4. Visagie, C. M., et al. "Aspergillus, Penicillium and Talaromyces isolated from house dust samples collected around the world." Studies in mycology 78 (2014): 63-139. Zamani, Mohd Ezman, Juliana Jalaludin, and Nafiz Shaharom. "Indoor air quality and prevalence of sick building syndrome among office workers in two different offices in Selangor."American Journal of Applied Sciences 10.10 (2013): 1140-1147.

This Blog is for All Things Cleanrooms, Testing, Monitoring, & More

Understanding Total Coliform Testing in Drinking Water: A Comprehensive Guide

What is Total Coliform Water Testing and Why is it Important?

Interpreting Total Coliform Results

When is Total Coliform Water Testing Necessary?

Understanding the Importance of Bacillus cereus Testing

What is Bacillus cereus

The Significance of Bacillus cereus Testing

Method of Bacillus cereus Testing

Ensuring Food Safety Through Rigorous Testing

Optimizing Food Safety: The Science of Shelf Life Testing

What is Shelf-Life Testing

Types of Shelf-Life Testing

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Understanding Heterotrophic Plate Count (HPC) in Process Water: A Key to Quality Assurance

"Breathe Easy with Sure-BioChem Laboratories: Understanding Air Quality Testing: Protecting Health in immediate Environments."

What is Air quality?

Factors that cause Pollutants

Why Check Air Quality Frequently

Necessary Steps to Keep Our Air Clean

Cleanrooms In Pharmaceutical and Biotechnology: Enabling Precision and Safety in Life Science

What Is a Cleanroom?

Why is Cleanroom Important

Cleanroom Technologies

Routine Environmental Monitoring of Airborne Viable Organisms

What Is Viable Environmental Monitoring?

Viable Sampling 101

Viable vs Non-Viable Sampling

Examples of Viable Particles

What Is Viable Air Sampling?

How Do We Monitor the Microbial Quality of Air?

Methods Used for Enumeration of Microorganisms in Air

Active Microbial Air Monitoring

Passive Microbial Air Monitoring

How Do You Assess Microbial Contamination?

Validating and Qualifying a Clean Room

Using a Portable Microbial Air Sampler

What Is a SAS Air Sampler?

ISO Air Quality Standards for Clean Rooms

How Often Must a Clean Room be Tested for Compliance With Air Standards?

Routinely Engage in Air Monitoring and Sampling to Stay Compliant

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Class D