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Nano-Particle Emissions Promote Air Quality Reduction

Airborne emissions are a fact of life for many in the world, levels of harmful compounds in the air and corresponding emissions rates have all seen significant increases over time. A layer of complexity accompanies these emissions as many of the necessities and comforts of life, rely in part on production methodologies that utilize high emissions processes. Nowhere is this more evident than in the power sector, where nearly 40% of the power generated in the U.S originating from coal fired power plants[1].

Though vital to the economic growth and stability of many industries, the use of coal fired power-plants is accompanied by detrimental environmental and health related issues. These issues were recently added to as environmental scientists out of Virginia Tech discovered an unusual variant of titanium oxide being emitted at high levels from coal fired power plants [3]. The discovery of this new variant of titanium oxide is alarming as it is a byproduct of the coal burning process. The study into this newly discovered molecule indicates that it is freely introduced into the air unless prevented by high-tech particle traps [3].

A subsequent study into this molecule established the bioactivity of this variant of titanium oxide displays and affinity for the respiratory system [2]. In testing particles of this form of titanium oxide, investigators observed that the particles traveled all the way into the air sacs then moved oxygen into the bloodstream when inhaled [2,3]. Given the method of dispersal and the affinity for the respiratory system, these particles were classified as having a high risk of toxicity [1,3]. Supplementary studies have shown that particles similar in composition to the titanium oxide variant are known to be responsible for many chronic and acute conditions like inflammation and irritation of the lungs as well as increased susceptibility to viruses and bacteria [3,4].

Recent air pollution data estimates that about 3.3 million premature deaths are attributed to polluted air; mainly due to pollution caused cardiovascular and respiratory illness [1]. In the major metropolitan cities, this is a major concern as many of the hazy days these cities experience are due to compounds like titanium oxide and other similar molecules [1,3].

For companies in that require specific conditions for manufacturing and production, a compound like titanium oxide can pose a serious threat. To mediate these concerns organizations have climate control systems equipped with HEPA filters [2,3,4]. These HEPA filters work by forcing incoming outdoor air through a fine mesh which removes particles like titanium oxide. Often, the maintenance and corresponding indoor environmental monitoring lag behind under stringent production deadlines [4]. As such, these organizations can be at significant risk of contamination and sub par products.

EPA guidelines advise that accredited testing laboratories, such as Sure-BioChem Laboratories, be utilized to ensure the integrity of HEPA filters as well as the overall quality of indoor air for manufacturers [3,4]. Implementing testing regimes with testing laboratories certified in environmental monitoring significantly helps to reduce the effects of industrial emissions affecting indoor air quality. At Sure-BioChem we also recommend homeowners and consumers be cognizant of their own indoor quality by using a HEPA filter air purifier, replacing filters regularly and introducing indoor plants. For more information concerning environmental monitoring, particulate matter testing and other air quality tests, contact Sure-BioChem at 888-398-7247 to get your consultation today.

References

1. Gurjar, B. R., et al. "Evaluation of emissions and air quality in megacities." Atmospheric Environment 42.7 (2008): 1593-1606.
2. Seaton, Anthony, et al. "Particulate air pollution and acute health effects." The lancet 345.8943 (1995): 176-178.

3. Virginia Tech. "Potentially harmful nanoparticles produced through burning coal: Environmental scientists led by the Virginia Tech College of Science have discovered that the burning of coal produces incredibly small airborne particles of a highly unusual form of titanium oxide with the potential to be toxic to humans." ScienceDaily. ScienceDaily, 8 August 2017.

4. Xu, Ying, et al. "Effectiveness of heating, ventilation and air conditioning system with HEPA filter unit on indoor air quality and asthmatic children's health." Building and Environment 45.2 (2010): 330-337.


Bath Towels Boost Microbial Growth and Diversity

Microorganisms often garner significant attention within the pharmaceutical and biotech industries; however, the influence of these microbes is routinely experienced by everyone.  A commonly overlooked household object where microbes often proliferate unchallenged is with cloth towels.  As part of our daily routine, we shower and bathe with little concern to the fact that cloth towels, specifically washing towels, are some of the most microbe laden objects in our homes.

Studies into this microbial vector, have yielded impressive results from the use of a technique called, bioburden testing.  With this test, researchers were able to analyze the number and types of organisms present in household bathing towels.  Results from the tests revealed that the “damp environment of the average bathroom allows germs on towels to thrive” [1,2].  One of the major conclusions the study highlighted noted that household items, like towels, often act as bacterial reservoirs that enhance the growth of microbes.  From these findings, the researchers also pointed out that when bathroom towels are consistently stored in areas with high moisture, not only does it promote bacterial growth but also encourages the growth of specific bacteria.

From the study, it was understood that one type of bacteria that is specifically promoted when bath towels are stored in high moisture areas are fecal coliform bacteria.  These fecal coliform bacteria are a common part of the natural microbial ecosystem called the microbiota; however, they often facilitate the growth of pathogenic microbes like Escherichia coli, otherwise known as E. coli [2].  Further characterization of these fecal coliform bacteria shows that other pathogenic bacteria like Citrobacter and Enterobacter are also present in household towels.  The diversity of these pathogenic bacteria found in household towels is intensified as it was also noted that 89% of kitchen towels also tested positive for E. coli [1].

The prevalence of these pathogenic fecal coliform bacteria presents a clear threat to homeowners and other occupants and increases the chances of illnesses like food poisoning and diarrhea [2].  However, these microorganisms are most threatening to young children and the elderly as they are susceptible to infections and other illnesses due to their less robust immune systems [1].  Additionally, family pets can be at risk for these illnesses as the pathogens responsible for the illnesses can be passed on from person to pet.

Though towels can represent a risk regarding health and well-being, properly cleaning your towels on a regular basis significantly reduces the risk of illness.  At Sure-BioChem Laboratories, we recommend washing your towels every four to five days.  We also advise that when washing your towels, to wash them in a high-temperature washing cycle to ensure that all the microorganisms are expunged.  For more information regarding fecal coliform bacteria, bioburden testing and other microbial tests contact Sure-BioChem at 888-398-7247 to get your consultation today.

References

1. Dovey, Dana. "The Gross Truth About Bath Towels."Medical Daily. Newsweek, 04 Oct. 2016. Web. 18 July 2017.

2. Sifuentes, Laura Y., et al. "Microbial contamination of hospital reusable cleaning towels." American journal of infection control 41.10 (2013): 912-915.


Prolonged Exposure to Multi-Species Biofilms Reduce Production Efficacy

            Global demand for biomedical devices and pharmaceuticals is forecasted to increase in prospective years.  Addressing these requirements requires a reliable framework that introduces additional logistical oversight to prevent contamination events.  Of the various potential contaminants, biological contaminants pose the greatest risk to ensured quality and production goals due to an increasing number of transmission vectors.  Recent research has highlighted biofilms as potent vectors for biological contamination events that impede the ability of manufacturers to meet product demand.

            Historically, robust control systems efficiently mitigated the impact of biological contaminants, like biofilms, through environmental monitoring protocols, bioactive chemicals, and physical deterrents.  However, the effectiveness of these procedures is in question as several bioactive chemicals, and physical deterrents are shown to have a reducing impact on biofilm formation.  The inefficiency of these antimicrobial compounds and physical deterrents stems from the inherently rigid internal structures of biofilms. According to recent studies, difficulties in biofilm removal are attributed to the hardy matrix encompassing the microbes that allows adherence to living or nonliving surfaces.  Furthermore, it's been observed that “biofilm growing bacteria exhibit increased tolerance against antibiotics, disinfectants, and innate and adaptive host immune mechanisms”(Høiby,58).  As such, microbes living in these biofilms are physiologically stronger and more resistant than cells of the same organism that may exist in isolation. 

            Current biofilm removal methods have varying success rates but ubiquitously require a labor intensive process involving physical shearing and highly caustic chemicals that often spread bacteria and compromise product quality. Moreover, new research “revealed that bacteria can communicate not only with their own species but also with different types of bacteria.” potentially resulting in multi-species biofilms (Beagle, 44).  For many manufacturers, this means that biofilms may actively spread different microbes and contaminants throughout production facilities.  Additionally, research has also observed outcomes from interspecies communication in biofilms resulting in an accelerated expansion of biofilms on various surfaces.  These observations affirm data from a recent study that 60-70% of “Foreign body infections... on intravenous catheters, intrauterine catheters, naso-laryngeal tubes, stents, alloplastic materials, hydrocephalus shunts and artificial hearts” are linked with biofilms. (Høiby, 62).

            Many current biological contaminant control strategies often lack new protocols addressing the robustness of prospective threats as well what recent research is advising. Presently, remediation of biological contaminants, like biofilms, requires an increased level comprehensive monitoring regimes as well as analysis of cleaning methodologies.  FDA regulations encourage medical and pharmaceutical manufacturers to utilize certified testing laboratories like Sure-BioChem Laboratories to develop and expand biological prevention protocols as well as supplement their existing testing regimes.  With our experienced and industry-leading team, Sure-BioChem Laboratories can help you meet your logistical and quality goals.

References:

1.       Beagle, Sarah D., and Steve W. Lockless. "Microbiology: electrical signalling goes bacterial." Nature 527.7576 (2015): 44-45.

2.       Høiby, Niels, et al. "Antibiotic resistance of bacterial biofilms." International journal of antimicrobial agents 35.4 (2010): 322-332.

3.       Høiby, Niels, et al. "The clinical impact of bacterial biofilms." International journal of oral science 3.2 (2011): 55


Protracted Regulatory Oversight Reduces Product Viability

             Medical devices play an integral part in the current medical ecosystem; advances in software and material science now allow for efficient diagnosis, monitoring, and treatment of persistent diseases. Production and manufacturing of medical devices are often complex and require rigorous regulatory oversight by organizations like the FDA here in the U.S and other analogous agencies in overseas markets.  Despite the stringent regulatory standards, lapses in regulatory oversight are commonplace and thus significantly increasing the risk of harm to consumers.

            Recently a well-regarded medical device manufacturer, known for its epinephrine injection devices, had to recall over 80,000 of its products worldwide due to a defect in their injection mechanism [1]. Analysis by the FDA and the company concluded that the error rendered the device ineffective for patients who bought the device [1,3].  Since the clientele who purchase these epinephrine injection devices are often susceptible to sudden acute allergic reactions, the risk to consumers was deemed unacceptable and required an immediate recall of the affected products. Currently, the recall affects the 0.3 mg and 0.15mg strengths of the epinephrine injection devices manufactured between 2015 and July 2016 [1].  Due to the scale and size the distribution network, regulatory agencies like the European Medicine Agency and other regulatory bureaus in the affected countries are working with the company to expedite and coordinate the recall efforts [3,4].

            Though this company is expected to absorb the financial, social and regulatory setbacks posed by this recall a comparable recall involving other businesses in the medical device industry could be crippling.  Recalls like the one currently in progress are, unfortunately, an unavoidable part of industries that provide lifesaving and revolutionary products to consumers [1,4].  Though the FDA other agencies detect the majority of these faults, the steady increase in the prevalence of medical devices and pharmaceutical drugs highlights a pressing demand for more efficient ways to mitigate these recall events [2,3].

            Ensuring the quality and safety of these devices and medicines is critical not only for the welfare of the consumers but the companies that manufacture them.  Widespread device failures that aren't promptly detected often result in costly losses through litigation [2]. Regulatory agencies like the FDA all advise that in-depth training be provided  for staff at these manufacturing plants so as to reduce production, documentation and human error at these manufacturing plants [1,3].  It should also be recognized that mechanical failure, though responsible for some recalls, is an often secondary risk factor for pharmaceutical and biotech manufacturers.  The majority of the recalls that these companies experience are often due to biological contaminants [1,2].

            Consistent training of staff and revision of quality standards is recognized as the best way to prevent recalls like the one above [1].  Furthermore, testing for chemical and organic contaminants that often find their way into these production facilities provides an additional assurance to the consumer, company and regulatory agencies.  Currently, industry standards advise that quality training and testing for biological contaminants be performed by an accredited laboratory like Sure-BioChem Laboratories.  Ensuring the efficacy and safety of your products is the top priority of our industry leading testing specialists.

 For more information, Contact Sure-BioChem at 888-398-7247 to get your consultation.

References:

1.     Affairs, Office Of Regulatory. "Recalls, Market Withdrawals, & Safety Alerts - Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector." U S Food and Drug Administration Home Page. Office of Regulatory Affairs, n.d. Web. 6 Apr. 2017.

2.     Gold, Kathryn M., and Victoria M. Hitchins. "Cleaning assessment of disinfectant cleaning wipes on an external surface of a medical device contaminated with artificial blood or Streptococcus pneumoniae."American journal of infection control 41.10 (2013): 901-907.

3.     Sorenson, Corinna, and Michael Drummond. "Improving medical device regulation: the United States and Europe in perspective."Milbank Quarterly 92.1 (2014): 114-150.

4.     Zuckerman, Diana M., Paul Brown, and Steven E. Nissen. "Medical device recalls and the FDA approval process." Archives of internal medicine 171.11 (2011): 1006-1011.


Protracted Chemical Loading Reduces Potable Water Quality

Water transfer systems are the main vectors for potable water distribution for residential and commercial occupants in the majority of inhabited communities.  For decades, these transfer systems were, and continue to be, the foundation for economic and social growth in communities worldwide.  However, long-term observational studies, following changes in the supplied water from these transfer systems raised several concerns.  Most prominent was a consistent long-term decline in the water quality of the reservoirs that these transfer systems drew from [1]. Consistent negative trends, like the ones observed from these studies, help to anticipate and remediate prospective water quality issues.

Communities around these reservoirs have experienced a marked increase in industrial and commercial development in recent decades. As such, water drawn from these reservoirs has consistently been subjected to elevated levels of perflourinated compounds (PFCs), heavy metals, organic toxins, nitrogen, mercury and pesticides [1].  Subsequent studies focused on these reservoirs show that these large bodies of water also absorb atmospheric pollutants like sulfur dioxide, nitrogen dioxide and aerosolized lead from the atmosphere [1,3].  Due to the crucial role these reservoirs and water systems play in the surrounding environment, enacting long-term sequestration protocols is vital to increasing the water quality of communities that draw from these systems [4]. 

Further studies also show that even the presence of trace amounts of organic pollutants in water can have far reaching effects on the public health and environmental stability.  Historically, air based industrial pollution was a major source of consistent chemical loading of organic pollutants like poly chlorinated biphenyls (PCBs) and pesticides in reservoirs [1,4]. However,  through stricter air quality regulations, concentrations of air based pollutants resulted in a dramatic pollution decrease in recent decades [4,5].  Nevertheless, potable water quality still remains an issue for municipalities worldwide.  It is believed that though we have experienced a reduction in air pollution, surface runoff, heavy metal and chemical discharge from super-fund sites and old industrial parks into streams that feed these reservoirs keep the overall quality of the drawn water consistently low [3,5].

Communities that draw from reservoirs contaminated with atmospheric and ground based sources of pollution present an ongoing dilemma for federal and local regulatory agencies [1,2].  Recently, the EPA was prompted by one such case where occupants at a trade-port in Pease, New Hampshire were found to have blood PFC concentrations that were four times higher than the recommended federal limit [2].  Further, testing on ground water reservoirs around the community found that the reservoirs had PFC concentrations that were 30 times higher than current EPA regulations [2,6].  Though the long-term health risks in exposed residents are yet to be determined, federal authorities are expected to fund a health monitoring program and a long-term health study of the toxicological effects that residents were subjected to [2].

Successful reduction in water-based pollutants is often a protracted process that jointly works to increase overall water quality in targeted water systems.  Investigators note that persistently high levels of surface runoff and chemical discharge are primarily due to a failure “to regularly measure and analyze pollutants” [1]. Consistent in-depth testing, analysis and management of water-based pollutants has been linked to increases in overall potable water quality.  Implementing a strategy with regards to surface runoff from these toxic sites near reservoirs is the current best prevention and remediation plan [1,6].  Regulatory agencies like the EPA, DEP and NOAA all advise that testing for these pollutants be performed through accredited and certified laboratories like Sure-BioChem Laboratories. Our experienced team offers industry leading year-round chemical and biological monitoring testing services.

For more information contact Sure-BioChem at 888-398-7247 to get your consultation.  

References: 
1. Brack, Werner, et al. "Towards the review of the European Union Water Framework Directive: Recommendations for more efficient assessment and management of chemical contamination in European surface water resources."Science of the Total Environment 576 (2017): 720-737.
2. Casey, Micheal. "Families on Edge over Water Contamination at Former Air Base."NewsOK.com. Associated Press, 04 Mar. 2017. Web. 06 Mar. 2017.
3. Moss, Brian. "Water pollution by agriculture."Philosophical Transactions of the Royal Society of London B: Biological Sciences363.1491 (2008): 659-666. 
4. Stephanie T. Ota, Geraldine L. Richmond. Chilling Out: A Cool Aqueous Environment Promotes the Formation of Gas–Surface Complexes. Journal of the American Chemical Society, 2011; 110426082204049 DOI:10.1021/ja201027k 
5. University of Rhode Island. "Great Lakes pollution no longer driven by airborne sources; land, rivers now bigger factors." ScienceDaily. ScienceDaily, 17 December 2014.
6. Wernersson, Ann-Sofie, et al. "The European technical report on aquatic effect-based monitoring tools under the water framework directive."Environmental Sciences Europe 27.1 (2015): 1-11.        


Biological Contaminants Accompany Industry Growth


The cornucopia of meals and snacks currently available to consumers, through food processing, has experienced a drastic increase in demand over time.  Advances in preservation technologies, transport, logistics and economic methodologies have brought about a current reality where food processing is an indispensable part of how consumers meet their daily dietary preferences.  The relative ease of acquisition, cost effectiveness, and extended shelf life has enabled processed foods to synergize flawlessly with the on-the-go lifestyle that’s become the norm for most consumers [5].  As such, the demand for these processed foods has risen and created a round-the-clock network structured around the production and distribution these food items.  In response to this increased demand many food distributors to expanded their manufacturing plants with larger and more complex food distribution systems.  These more modern systems often operate with a high turnover rate and with as minimal interference to production as possible.  As such, the amplifying complexity, size of staff and long operational hours puts food distribution plants at a greater risk for contamination events [2,4,5].

 Contingent on a wide array of factors, contamination events are most commonly associated with contaminated machinery, cross contamination from food and staff,  improper cooking practices and a lack of proper hygiene and sanitation [4].  Pinpointing the exact cause of a contamination event is an often a laborious and open-ended investigation that usually uncovers a plethora of sanitation and sterility issues [3,4].  Conclusions from investigations into contamination events often lead to significant fines, recalls and the compulsory implementation of recommendations geared toward tightened adherence to appropriate hygiene and sanitation protocols [1,3].  Though contamination events have experienced a decrease in the past decade due to varying layers of internal and external quality control; contamination events can and do still occur with regularity. Recently, a major food manufacturer was subject to a contamination event that compromised seven of its most popular cheese products.

While information regarding the contamination event is still pending, it's believed that the bacterium Listeria is culpable for the contamination [4,6].  Listeria, otherwise known as Listeria monocytogenes, is notorious among scientists and food manufacturers as it's known have large growth interval ranging from to 4°C (39.2°F) (the temperature of a refrigerator) to 37°C (98.6°F) (the body's internal temperature) [6]. Often found in ready-to-eat processed foods containing meat, poultry, seafood and dairy products, Listeria monocytogenes, effectively contaminates foodstuffs stored in refrigeration units for an extended period. Consumption of these contaminated foods results in a condition called Listeriosis which causes fever, nausea, muscle aches, and gastrointestinal irregularities [2,46].  Though most cases of listeriosis often resolve themselves without the need for intensive medical treatment, 89% of listeria infections result in hospitalizations and of the infected populace there about 250 reported deaths [5]. Listeriosis is often severe in persons with weakened immune systems, young children, the elderly and pregnant women [3,4,6].  Currently, there are no reported cases of listeriosis from consumers of these cheese products.

Presently, antibiotics are the most effect way of treating severe cases of listeriosis, however medical professionals ubiquitously advocate for a prevention-based approach.  Prevention of pathogenic and sometimes deadly microorganisms like Listeria monocytogenes is best accomplished through a year-round microbial monitoring regime [5,6].  Utilization of specialized testing laboratories like Sure-BioChem Laboratories is recommended by all public health and manufacturing regulatory agencies. Companies involved in food processing and packaging should remain as cautious as ever with the rise of more pathogens like listeria.

Contact Sure-BioChem to get your microbial monitoring consultation before your products are distributed.

           

References

  1. Bennion, J.R., et al., “Decreasing Listeriosis Mortality in the United States, 1990-2005,” CLINICAL INFECTIOUS DISEASES, Vol. 47, No. 7, pp. 867-74 (2008).
  2. "Clinical Features/Signs and Symptoms."Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 10 June 2015. Web. 22 Feb. 2017.
  3. Conlon, Kevin, Euan McKirdy, and Johanzynn Gatewood. "Cheesemaker Sargento expands listeria recall, cuts supplier."CNN. Cable News Network, n.d. Web. 20 Feb. 2017
  4. Demakos, Peter G. "Prevent and Control Listeria."Food Quality & Safety. N.p., 01 Dec. 2008. Web. 22 Feb. 2017.
  5. FDA, “Bad Bug Book: Foodborne Pathogenic Microorganisms and Natural Toxins Handbook—Listeria monocytogenes,” at http://www.fda.gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnaturaltoxins/badbugbook/ucm070064.htm (site last updated: April 3, 2012).
  6. "Todar's Online Textbook of Bacteriology".Listeria monocytogenes and Listeriosis. Kenneth Todar University of Wisconsin-Madison Department of Biology. 2003. Retrieved 7 March 2007.

Public Health Emergency:  Lead Contamination Endangers City


     In recent years, public health policies have been at the forefront of nationwide efforts to increase the overall health and quality of living for all residents.  In spite of these efforts, public health concerns continue to be a persistent problem in the city of Flint, Michigan.  Recently, high levels of lead and trihalomethanes were discovered in the city’s water supply.  Investigators identified that the cause of the increased levels of lead and trihalomethanes was a result of a proposed cost saving program that was enacted by the City of Flint [1].  Under this program, the City of Flint chose to reduce their water acquisition costs by leaving the Detroit Michigan water system, which used water from the great lakes, to a system that used water from the local Flint river. 

     Unfortunately, proper measures were not enacted upon to make the purification and transportation of the Flint River water viable as the city’s  primary source of water.  Several ecological studies had shown that the water from the Flint River was known to be significantly more saline in its composition when compared to the lake water used by Detroit.  Due to its higher salinity, the water from the Flint River required additional steps in the purification process to make the water drinkable [3].  By not heeding to these additional purification steps, the increased salinity of river water resulted in the corrosion of the metal pipes which were joined together by lead soldering.  As a result, the Flint River water corroded the pipes and lead leeched into the municipal drinking supply [3].  

     Independant EPA reports discovered a two fold increase of lead levels in the water supply when compared to tests done before the move to the Flint River water supply. Consequently, the increased levels of lead were observed directly by healthcare officials in the blood of infants and children [1]. Under the Clean Water Safety Act, all public water systems are mandated to be regularly monitored for contaminants. The events that are unfolding in Flint, Michigan highlight the significance of providing potable water to all residents. Studies by the the World Health Organization (WHO), and the EPA  show that access to clean water is the single most impactful determinant of health for both individuals and communities.  Other independent studies show various adverse effects from contaminated water include “ disruption of the endocrine, the reproductive, and the immune systems, as well as their ability to cause behavioral problems, cancer, diabetes, and thyroid problems.”[1,2,3]

    The events that are taking place in Flint, Michigan can happen in any city or municipality across the nation.  Prevention of such widespread damage to the community is the only definitive measure that can be depended on to mitigate contamination risks.  As such, the EPA recommends that water samples from all municipalities and cities “must be analyzed using EPA-approved testing methods, by laboratories that are certified by EPA or a state agency.”[3].  Here at Sure-BioChem Laboratories, we can provide you and your surrounding community with the peace of mind you need by ensuring that the quality of your drinking water is not compromised by dangerous contaminants.  Our experienced team adheres to strict sampling protocols, methods and regulatory reporting requirements, that cover detection of iron, lead, manganese, arsenic, mercury, nitrates and volatile organic compounds.

With the SBL team, you can be sure of the safety of your drinking water.  Contact us now for a consultation at 888-398-7247 or visit us at surebiochem.com.

1.    http://www.who.int/hia/evidence/doh/en/
2.    Schwarzenbach, René P., et al. "Global Water Pollution and Human Health."Annual Review of Environment and Resources 35 (2010): 109-36. EPA (2012).
"Safe Drinking Water Act Analytical Methods and Laboratory Certification."

Unseasonably Warm Weather Patterns Result in Mold Related Allergy Spikes


    This year's unseasonably warm winter has resulted in a spike of climate related allergies and asthmatic conditions, as many doctors are reporting “about 20 to 30 percent more patients experiencing mold allergies due to the recent warm spell.”[1]. This marked increase in mold allergy related illnesses is due to the proliferation of mold spores associated with the warm and humid environmental conditions this winter. Typically, the winter months in the northeastern United States are characteristized by cold, dry air which serves to suppress the growth of mold spores. Exacerbating this winter-time spike in mold-related allergies and conditions is the common practice of opening windows to let in fresh air. This practice often times increases the number of mold spores entering the workplace resulting in adverse health conditions for allergy sufferers.

    Fortunately, climate control systems in the form of high-efficiency particulate aimany workplaces and administrative buildings have allergy and r (HEPA) filters. These HEPA filters work by forcing incoming airflow through the fine mesh of the HEPA filters thus removing mold and allergen particles. However, these HEPA filters are not without their limitations, as they can and often do allow trace amounts of allergens and pathogens into the workplace. During typical winter weather patterns, the trace amount of allergens that escape capture by these HEPA filters would pose no problems for healthy individuals in the workplace, as the dry winter air would inhibit their growth.

    Nevertheless, the unseasonably warm and moist winter air that we are currently experiencing ensures that these trace amount of allergens and pathogens will proliferate and cause increased “exposure to harmful indoor pollutants”[2]. Studies have found a correlation between an increase in indoor pathogens and allergens and a condition called “sick building syndrome” which is characterized by “an excess of work-related irritations of the skin and mucous membranes and other symptoms, including headache, fatigue and difficulty concentrating” [3].

    Current EPA guidelines advise that to ensure well-ventilated spaces, accredited testing laboratories, such as Sure-BioChem Laboratories, should be used. Utilizing testing laboratories certified in environmental and microbial monitoring significantly helps to reduce the effects of poor indoor air quality. Sure-BioChem Laboratories specializes in providing testing and certification that is industry and federally approved. Our experienced team offers testing for mold, particle counts, HEPA filter integrity testing, airflow volume/velocity, temperature and year-round microbiological monitoring.
        
1.    http://www.cnbc.com/2015/12/15/unusually-warm-weather-triggers-mold-allergies.html
2.    Rackes, Adams, and Michael S. Waring. "Modeling impacts of dynamic ventilation strategies on indoor air quality of offices in six US cities."Building and Environment 60 (2013): 243-253.
3.  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.


Seasonal Perturbations of Microbial Potency in Manufacturing Production


    Weather perturbations often create noticeable changes in the efficacy of pharmaceutical products. Across the board, pharmaceutical manufacturers remain cognizant of how different weather conditions can substantively increase contamination risks. Nonetheless, this awareness often does not translate to viable and noticeable precautionary measures.     

Many pharmaceutical manufacturing companies often choose to mitigate the risk of microbial contamination by using High- Efficacy particulate air (HEPA) filters in and around their manufacturing floors in order to maintain a stable microbial load. Given the efficiency of the HEPA filters and the cleaning regimes that many pharmaceutical manufactures employ most pathogenic contaminants are are captured, which drastically reduces the risk to consumer health[1].

    However, Irrespective of the externally variable and internally controlled environments of pharmaceutical manufacturers an increasing number products are being recalled from these companies due to microbial contaminants that have been detected. Further investigations revealed the cause of these wintertime recalls was due to HEPA filter integrity failure[2]. Although HEPA filters are very effective at “removing particles the size of 3 microns or larger” other “dust particles smaller than 3 microns will pass through unhindered” [4]. This means that for objects smaller than 3 microns like certain mold spores, animal dander and fine dust particles, HEPA filters do little to prevent their entry into sterile pharmaceutical manufacturing areas. And given that abnormally warm months in the winter and the summer are often characterized by high levels of fine dust particles, mold spores and animal dander, contamination risks for pharmaceutical manufactures increases significantly during these times [3,4]. In addition, a HEPA filter collects only mold spores, it does not address the cause as “the mold that created the spores is still alive and continues to generate mold spores.” in the HEPA filters thus increasing contamination risks [4]

    Though many pharmaceutical manufacturers often overlook the dangers of manufacturing protocols that aren't responsive to seasonal changes; the creation and implementation of effective sterility manufacturing protocols is a must for pharmaceutical manufacturers. The FDA and the EPA both outline what pharmaceutical manufacturers need to adhere to their stringent indoor microbial standards. For many manufacturers though, using their limited financial resources to actively create, implement and maintain these stringent FDA and EPA guidelines often proves to cut into their bottom line.

    As such, the FDA and the EPA both suggest that pharmaceutical manufacturers utilize testing laboratories certified in environmental and microbial monitoring. These certified testing laboratories are known to significantly mitigate and reduce the potential resource shortfalls that companies often face when approaching this problem. Sure-BioChem Laboratories specializes in providing testing and certification that's industry and federally approved. Our experienced team offers testing and certification for room pressurization, temperature, LAL testing, Efficacy of Antimicrobial Preservation testing, sterility testing and year-round microbiological monitoring.

Achieving a verifiable standard of microbial sterility year-round is important for any company in the manufacturing sector. Having pharmaceutical manufacturing plants certifiably accredited for sterility by a verified laboratory significantly reduces the of risk product contamination and unwanted audits to your product and company.

For additional information regarding your clean-room sterility contact Sure-BioChem Laboratories for your microbial monitoring consultation today.

1.    Xu, Ying, et al. "Effectiveness of heating, ventilation and air conditioning system with HEPA filter unit on indoor air quality and asthmatic children's health." Building and Environment 45.2 (2010): 330-337.
2.    Korves, T. M., et al. "Bacterial communities in commercial aircraft high?efficiency particulate air (HEPA) filters assessed by PhyloChip analysis."Indoor Air 23.1 (2013): 50-61.
3.    Shintani, Hideharu. "Validation Study on How to Avoid Microbial Contamination during Pharmaceutical Production." Biocontrol     science 20.1     (2015): 1-10.     
4.    Yassin,     M. F., and S. Almouqatea. "Assessment of airborne bacteria and fungi in an indoor and outdoor environment."Int.     J. Environ. Sci. Tech     7.3     (2010): 535-544.   
    

Wintertime Resurgence of Bacterial Infections

The later months of the year are commonly known to bring stark changes in both the environment and the health of countless individuals. While the fall and winter months are primarily referred to as the flu season, other pathogenic infections can sometimes emerge in the winter months. E.coli is an example of one such pathogen that can be dormant in the winter months but sometimes experience a wintertime resurgence given the right environmental conditions.
    
    Recently, a national restaurant chain has been at the center of an uncharacteristic wintertime E. coli outbreak. Public health officials are reporting that the number of individuals affected by this restaurant’s outbreak currently stands at 50 in 6 states across the country and is expected to rise. Early testing of the affected individuals by the FDA and medical officials shows that each of these individuals are infected with a strain of E. coli called Shiga Toxin-producing Escherichia coli O26 (STEC O26). This particular strain of E. coli is known to produce a class of harmful bio-active toxins called shiga toxins which can frequently result in inflammation, hemmoragic colitis, abdominal pain, severe cramps, vomiting, diarrhea and fever. The associated illnesses resulting from STEC O26 strains of E. coli typically last for about 12 days post ingestion. In the current outbreak, no deaths have been reported thus far; however, there have been 16 confirmed hospitalizations as a result of this food-borne outbreak.

    Further efforts by the FDA to isolate the potential contamination vectors have thus proved inconclusive with regards to pinpointing the source of the E. coli contamination. As a result, this national restaurant has closed all of its branch locations in the northwestern part of the United States until the source of the outbreak is identified.

    L. monocytogenes is another example of a common bacterium that is responsible for seasonal  winter outbreaks of Listeria in the meat and dairy industries worldwide. L. monocytogenes is known for its inherent cold tolerant characteristics; however, this characteristic is not often emulated by the majority of microorganisms. Recent studies have observed that “independent of season, monthly humidity, monthly precipitation, and long-term trends, each 5.6°C (10°F) rise in mean monthly temperature corresponded to increases in Gram-negative bacterial” infection rates.[3]. The observations from this study validate the fact that the colder environments associated with the winter months often inhibit the infection rates of bacterial species.

    Conversely, the observations from the previous study should be considered with caution due to the fact that during the winter months, the majority of human activity is primarily situated in indoor, climate-controlled environments typically between 60 to 70 degrees Fahrenheit. These climate controlled environments that we often inhabit in the winter months are ideal for arresting the fall of indoor temperatures and thereby give pathogens commonly seen in warmer months a bastion to occupy [2]. The warmer indoor environments, coupled with poor sanitation practices, contaminated food sources and untested food preparation stations, can potentially cause a significant increase in the risk of microbial contaminations in the winter months, as is seen with the recent STEC O26 outbreak.

Sure-BioChem Labs suggests that companies involved in the food service and food packaging industries remain cautious in the winter months, as outbreaks can halt the service and production of respective companies. Preventing microbial outbreaks can save companies from financial and reputation damage. Our experienced team specializes in testing for biosafety level 1 and 2 organisms and can educate clients on the proper steps to take in the case of a positive E. coli test result or other pathogenic contaminations. SBL’s rapid analysis, reporting and consultation services help to provide your business with an additional layer of security to prevent wintertime outbreaks .

Contact Sure-BioChem at 888-398-7247 to get rapid detection of pathogens before your products are compromised.

1.    Eisenstein, Barry and Zaleznik, Dori, “Enterobacteriiaceae,” in Mandell, Douglas, & Bennett’s PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASES, Fifth Edition, Chap. 206, pp. 2294-2310 (2000).
2.    Griffin,     Patricia and Tauxe, Robert, “The Epidemiology of Infections Caused by Escherichia  coli O157:H7, Other Enterohemorrhagic E. coli, and the Associated Hemolytic Uremic Syndrome,” EPIDEMIOLOGICAL REVIEW, Vol. 13, pp. 60-98 (1991).
3.    Boyce, T.G., et al., “Escherichia coli O157:H7 and the hemolytic-uremic syndrome,” NEW ENGLAND JOURNAL OF MEDICINE, Vol. 333, pp. 364-368 (1995).     
4.    Tarr, Philip, “Escherichia coli O157:H7: Clinical, Diagnostic, and Epidemiological Aspects of Human     Infection,” CLINICAL INFECTIOUS DISEASE, Vol. 20, pp. 1-10 (1995).         
5.    Frankel,     Mika, et al. "Seasonal variation of indoor microbial exposures     and their relations to temperature, relative humidity and air exchange rates." Applied     and environmental microbiology (2012):     AEM-02069.     
6.    Perencevich, Eli N., et al. "Summer peaks in the incidences of gram-negative bacterial infection among hospitalized patients." Infection Control 29.12 (2008): 1124-1131.    
7.    "Multistate Outbreak of Shiga Toxin-producing Escherichia Coli O26 Infections     Linked to Chipotle Mexican Grill in Washington and Oregon."Centers     for Disease Control and Prevention.     Centers for Disease Control and Prevention, 17 Nov. 2015. Web. 19     Nov. 2015.


Monitor Your Environment, Monitor Your Assets

Environmental monitoring (EM) is a process of microbial testing that detects trends of colonies in a controlled environment or cleanroom. Poor EM is an invitation for microbes to camp on surfaces, personnel, and even air. Depending on the manufacturer, contamination can have varying impacts, however one result remains constant. Accumulating microbes means loss of time, money, and products. With growing colonies around every corner, taking risks with EM could mean recalls, delays, shortages, and loss of public reputation. With EM so critical in today’s manufacturing business, more in the industry are seeking the help of outsourced testing services.

Cleanrooms are designed for easy upkeep. Hard floors and surfaces, fabricated from smooth material, lacking crevices to trap particles are crucial. Design is but a single key in keeping Good Manufacturing Practices, which are ensured by the FDA to give manufacturers a consistent and controlled production system (1,2). If the Critical Control Points in a facility are compromised, a clean area and environment can be scarcely maintained. Critical Control Points are enacted to prevent or eliminate present hazards that arise from the production process (3).

Sure Bio-Chem Laboratories caters to these occurrences for new and established businesses alike. For start-ups, SBL can provide Cleanroom Certification to create high standards of GMP for your staff. As for established facilities, SBL’s certification is relevant for re-certification following facility renovations. The cleanroom’s integrity depends not only on the hygienic practices of the employees, but environmental monitoring.

The FDA requires facilities to have EM these systems and others to prevent microbial contamination and facilitate public well being. Good Manufacturing Practices can prevent FDA warning letters, however few EM programs will always meet their expectations. SBL is an expert in Environmental Monitoring, and can establish new EM plans or support existing plans. Based on your needs, SBL can advise what micro sampling methods and sampling locations your facility should focus. With SBL monitoring your cleanroom, we provide frequency trend reporting and establish alert and action limits. SBL interprets your results and support investigations for out-of-spec results.

Click here to contact us and request a service!

References
1. http://www.ispe.org/gmp-resources
2. http://www.fda.gov/food/guidanceregulation/cgmp/
3. http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm#defs

Mold Outbreak: Can You Afford One?

Outbreaks can mean months of investigation for the company involved, the FDA, CDC and other public health departments. It can mean hundreds of recalls on product and a damaged company name from growing distrust. A 2014 mold outbreak resulted in the fatality of a 29-week-old infant. A product recall in over 25 states across the United States followed. The premature infant experienced immune system trouble and the hospital attempted to remedy the issue by treating the child with a probiotic.

Probiotics can be found in yogurt, capsule, or powder form and is intended to flood the consumer’s large intestine, or colon, with healthy bacteria over time. The harmless bacteria from these sources are valuable because they occupy space and nutrients, which otherwise a harmful microbe could nest in. Being preterm, the infant lacked both a fully functioning immune system and precious gut microbes to prevent the mold’s spread.

The mold, Rhizopus Orgzae, is an opportunistic fungus that takes residence is dead matter. Upon surgical investigation, the hospital found the infant’s bowel was necrotized, which happens when cells die. The bowl was heavily inhabited by the fungus, which caused mucormycosis. Mucormycosis is a rare, acute infection caused by fungus of the order Mucorales. Symptoms include abdominal pain, vomiting, nausea and fever (1).

These is little to be done in sensitive cases where patients have a compromised immune system. The irreplaceable loss of a child cannot be reversed nor could it be foreseen. Outbreaks like this highlight the importance of utilizing numerous resources before shipping products. Outbreaks are preventable with the right education and resources. Good Manufacturing Practices, like what Sure-BioChem promotes, lessens the risk for financial and emotion expenses that could punch holes in a company. Take advantage of SBL’s Environmental Monitoring to identify any molds, viruses, or bacteria in your products or request Cleanroom Training where SBL can assist you in creating efficient philosophies for your company to stick by.

References
1. http://www.cdc.gov/fungal/diseases/mucormycosis/


Compressed Air Contaminants Associated with Reduced Production Efficacy

Monitoring and testing compressed air and other gases is crucial to assuring the safety and quality of many pharmaceutical and manufacturing products. Through several contamination events, water vapor, oil vapor, microorganisms and particles have been identified as primary sources of compressed air contamination [3]. The mechanisms by which these compressed air contaminants enter manufacturing and pharmaceutical products is often varied. Through several studies, it has been observed that most compressed air contamination events occur due to human error in application and errors within the compressed air system itself [2,3].
Unfortunately, most pharmaceutical and manufacturing companies often overlook testing the compressed air containers they use. Studies have shown that the air systems these companies utilize can often harbor the required nutrients for microbes to proliferate in the damp and warm environments of many compressed air systems [1,2]. Concurrently, the proliferation of these microbes becomes an additional risk as the compressed air systems are aerosolizing the bacteria that incubates in these systems. Even companies that actively maintain low temperature environments near -40°F are often susceptible to microbial and particulate contamination from compressed air since the lowered temperature doesn’t affect particulate matter, only inhibits microbial growth and does not eliminate the microbial source [2].
Given the consumer risk associated with compressed air contaminants in pharmaceutical and manufacturing products, the International Organization for Standardization (ISO) developed an air test protocol. Within this air testing program called, ISO 8573-7, companies are provided a testing method that enables them to distinguish colony forming microbiological organisms from solid particles in compressed air [4]. Though many companies may not have the appropriate staff and equipment to effectively and efficiently carry out ISO 8573-7 compressed air testing, ISO testing protocols can still be carried out by certified testing laboratories [2, 4].
As a matter of due diligence and industry standards, it is highly recommended that your compressed air monitoring and testing be completed on all existing and planned compressed air canisters by certified testing laboratories like Sure-Biochem Laboratories. Sure-BioChem Laboratories specializes in providing the highest quality compressed air testing and monitoring services year-round. Our experienced team is trained in producing verifiable testing services based on industry standards and our commitment to quick and reliable results can help your company be assured of your compressed air usage.

For additional information regarding our environmental monitoring services contact Sure-BioChem Laboratories at 888-398-7247.

1. Addala, Anirudh, and Srinivasu Gangada. "Fabrication and Testing of Compressed Air Car." Global Journal of Researches In Engineering 13.1 (2013).
2. Kim, Tae Gwan, and Kyung Suk Cho. "Microbial community analysis of a methane-oxidizing biofilm using ribosomal tag pyrosequencing." Journal of microbiology and biotechnology 22.3 (2012): 360-370.
3. Sandle, Tim. "Microbiological assessment of compressed gases in pharmaceutical facilities." Facilities 21.2 (2015).
4. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=31385


PM2.5 Particulates Associated with Increased Medical Device Contamination


Findings from a recent study published by the NIH, observed a positive correlation between exposure to PM2.5 particulate air pollution and an increase in the prevalence of cardiovascular (CVD) related deaths [5]. Though startling, these findings run parallel with previous studies that have helped categorize and elucidate the eye, lung and throat health complications often associated with exposure to PM2.5 particles. However, recent findings, have also linked extended particulate matter exposure with an overall increase in indoor bacterial populations [2,3].
Mechanistically, the observed increase in indoor bacterial communities from PM2.5 particle exposure can be attributed to an increase of fine particles that have been inoculated with pathogenic cells [3,6]. It has been shown that transmission of these aerosolized, bacterially inoculated PM2.5 particles can serve to allow greater bacterial colonization of many climate controlled indoor environments. Subsequent studies have shown that based on the “size of these ‘agglomerates’”, differing bacterial species can be carried into indoor environments by way of pollen, fungal spores, dust and water droplets [1,3].
Based on these findings, the compounded risks of PM2.5 particulate associated complications can pose a significant public health risk irrespective of time or season. Nowhere are these complications more compounded than in the medical centers, where the sensitive nature of patients, the environment and treatments are crucial to providing proper health call. Consequently, having PM2.5 particulates inoculated with pathogenic cells in these medical environments can exacerbate potential complications, especially with medical devices [2, 5].
In many medical institutions, medical devices are often used as a way to allow doctors greater access to the areas of concern in and around the patient. However, these medical devices often prove to be complex in their assemblages, and as a result, often have many areas that are hard to clean through conventional chemical protocols. Subsequently, the use of advanced medical devices that frequently come into contact with the internal organs of many patients, compounded with often have hard to clean areas, enable pathogens present in the environment to flourish and proliferate [5,6]. Given this ideal environment for pathogenic multiplication, having potentially pathogenic PM2.5 particles flowing freely in an hospital environment can lead to severe unwanted outcomes [1,3,4].
As a matter of due diligence and safety, it is highly recommended that your medical devices, indoor air supplies and medical surfaces be tested by certified testing laboratories like Sure-Biochem Laboratories. Sure-BioChem Laboratories specializes in providing the highest quality compressed air testing and monitoring services year-round. Our experienced team is trained in producing verifiable testing services based on industry standards, and our commitment to quick and reliable results can help your company be assured of your indoor air quality.

For additional information regarding our environmental monitoring services contact Sure-BioChem Laboratories at 888-398-7247.

1. Duquenne, Philippe, Geneviève Marchand, and Caroline Duchaine. "Measurement of endotoxins in bioaerosols at workplace: a critical review of literature and a standardization issue." Annals of occupational hygiene 57.2 (2013): 137-172.
2. Hospodsky D, Qian J, Nazaroff WW, Yamamoto N, Bibby K, Rismani-Yazdi H, et al. (2012) Human Occupancy as a Source of Indoor Airborne Bacteria. PLoS ONE 7(4): e34867. doi:10.1371/journal.pone.0034867
3. NYU Langone Medical Center. "Link between air pollution, increased deaths and increased deaths from heart disease affirmed." ScienceDaily. ScienceDaily, 15 September 2015. <www.sciencedaily.com/releases/2015/09/150915094302.htm>.
4. Smith, David J., et al. "Free tropospheric transport of microorganisms from Asia to North America." Microbial ecology 64.4 (2012): 973-985.
5. Thurston, George D., et al. "Ambient Particulate Matter Air Pollution Exposure and Mortality in the NIH-AARP Diet and Health Cohort."Environmental health perspectives (2015).
6. Yamaguchi, Nobuyasu, et al. "Global dispersion of bacterial cells on Asian dust." Scientific reports 2 (2012).


The Contamination of Drinking Water: Concerns for Children in School Systems

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.
 
Microbial Sterility Guidelines Enhance Product Quality

Recent spikes in several subtropical and tropical diseases such as Zika, Dengue and Malaria, accompanied with the rise of many other existing chronic conditions has resulted in a demand spike for intravenously (IV)  injected medications. The expedited delivery method for these IV drugs and the corresponding quick uptake of these medications often makes them the preferred option for the medical community [1].  However, the same purported benefits of these IV drugs can also put a patient at significant risk if the the sterility of the medication is in question.

In the past several months, several cases have been reported where entire batches of IV medications  were recalled due to the presence of both microbial and particulate contaminants in these drugs [4,5].  It goes without saying that the presence of these foreign compounds in medication that is intended to be delivered directly into the patient's system poses a huge health risk for the patients using these medications [2].  Moreover, having microbial and particulate contaminants in these drugs raises serious questions as to the efficacy and the sterility protocols used by the manufacturers.  Oftentimes, these questions result in significant public backlash and financial penalties.

Fortunately,  certain measures can be taken to significantly reduce the chances of both microbial and particulate contamination [1].  Under the established US pharmacopeia (USP) standards, membrane filtration and direct inoculation methodologies provide a demonstrable way for companies to test for contaminants in their products [2,4].  With membrane filtration, colonies of bacteria and particulates can easily be isolated by physical separation through a .45 micron filter paper [4].  Further characterization of the captured microorganisms and particulates is done following a set period of incubation [3,5].

Though the membrane filtration method is most effective at detecting a wide array of potentially detrimental microorganisms and particulates, there are still potentially pathogenic microorganisms that the .45 micron filter paper cannot reliably capture [2].  For these microbes, the direct inoculation method of sterility is effective for detecting these microorganisms in aqueous solution [2,5]. Furthermore, the direct inoculation method provides a reliable testing method that wastes less product compared to the membrane filtration method [5]. For the preparation of the direct inoculation method, the test solution is inoculated directly into bottles or tubes that contain the appropriate testing media and are incubated for set period of time.  For use in the pharmaceutical and biotech industries, utilization of both sterility testing methods is recommended under USP guidelines [1,2,5].

However, due to the increase in product demand for aqueous drugs, many biotech and pharmaceutical companies find themselves trying to meet tight production deadlines.  Subsequently, sterility assurance methodologies like these are not implemented at the frequency that they should.  Subsequently, this results in increased occurrences of IV medication recalls which puts the companies at risk for legal action.  Sure-BioChem Laboratories specializes in providing the highest quality pharmaceutical drug testing and monitoring services year-round.  Our experienced team is trained in enacting direct inoculation sterility testing services based on industry standards, and our commitment to quick and reliable results can help your company be assured of your production standards.

For additional information regarding our microbiological testing services, contact Sure-BioChem Laboratories at 888-398-7247.

References:

1.     Turnidge J. 2015. Susceptibility Test Methods: General Considerations, p 1246-1252. InJorgensen J, Pfaller M, Carroll K, Funke G, Landry M, Richter S, Warnock D (ed), Manual of Clinical Microbiology, Eleventh Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817381.ch70

2.     United States Pharmacopeia and National Formulary (USP 30-NF 25). Vol 2. Rockville, MD: United States Pharmacopeia Convention; 2007:1553-1554.

3.     Lagier JC, Hugon P, Khelaifia S, Fournier PE, La Scola B, Raoult D.Clin Microbiol Rev. 2015 Jan; 28(1):237-64.

4.     Wang X, Yamaguchi N, Someya T, Nasu M. J Microbiol Methods. 2007 Oct; 71(1):1-6. Epub 2007 Jul 6.

5.     http://www.who.int/medicines/publications/pharmacopoeia/TestForSterility-RevGenMethod_QAS11-413FINALMarch2012.pdf


Does The Air You Breathe Meet W.H.O Standards?


The quality of the air available to human populations is a concern, as it is an indicator of the pollution levels of a given residential area. It is also an issue for public health authorities worldwide. A recent publication indicated that only 2% of cities in countries regarded to be of reduced socioeconomic status comply with WHO guidelines for air quality. On the other hand, 44% of cities in high income countries comply with WHO guidelines for air quality1. The figures in this release also suggested that less than 20% of all people living in cities have access to air that is not regarded as harmful1. Air-pollution levels in cities were recently observed (c. 2013) to have increased by 8% in five years1. It is seen as a serious health concern, particularly in cities that are at the center of considerable economic and population growth over the last few decades, e.g. Bangkok or Shanghai2. The severity of air quality-related health burdens are thought to be influenced by several factors, including the age range of the individual patient, the use of air conditioning technology in buildings and the general climate of the area in question2.

Prominent atmospheric pollutants include sulphur dioxide (SO­­2), nitrogen dioxide (NO­2), ozone (O­3) and particulates2. These particulates are solid matter that can remain suspended in the air and has an approximate diameter of 10µm or less – or, in other words, are small enough to float and be taken into the lungs2. Other example of air pollutants may include volatile organic compounds, carbonyls, metallic compounds and polyaromatic hydrocarbons3. These pollutants may be measured in terms of their concentration per 10µg/m­3 of air2. The intake of air polluted with these particles and gases is associated with detrimental effects on respiratory and cardiovascular tissues2. They may also affect other areas of health. A 2011 health impact study that reviewed 13 studies in addition to public data on air quality in Guangzhou, China’s third largest city, claimed that nearly all particulate concentration values recorded exceeded international standard levels, and that approximately 10,000 premature deaths could be avoided if this was not the case4.

The pollutant types as above are typically linked to atmospheric pollution, or poor air quality outside buildings. However, air quality is also an issue inside buildings. Research has demonstrated that poor indoor air quality may be associated with reductions in productivity of up to 9%, impaired performance and detriments to the subjective experience within workplaces5. People may encounter other air pollutant types indoors, which may include particulates derived from flooring materials5. Other sources of indoor air pollutants include organic, hydrocarbon and metal-based types, which may be released from smoking products (including e-cigarettes) when their consumption is allowed indoors3.  Methods that may improve indoor air quality may include ventilation, which conveys ‘fresh’ air in from outside the building5. However, devices and technologies such as air filters or conditioners are regarded by some researchers as more effective in clearing indoor air from pollutants5. Other methods of air quality management include the provision of more trees in affected areas6. These plants may offer effective, natural methods of removing pollutants through a process called dry deposition6. Therefore, many initiatives to plant more trees to improve air quality have been carried out in the United States6. Research is currently underway to evaluate the efficacy of these measures, in terms of changes to the concentrations of SO­­2, NO­2, O­3 and particulates of about 2.5µm in diameter, but has not yet produced conclusive results6.

References:

1.         Limb M. Half of wealthy and 98% of poorer cities breach air quality guidelines. BMJ. 2016;353.

2.         Wong CM, Vichit-Vadakan N, Vajanapoom N, et al. Part 5. Public health and air pollution in Asia (PAPA): a combined analysis of four studies of air pollution and mortality. Research report (Health Effects Institute). 2010(154):377-418.

3.         Schober W, Szendrei K, Matzen W, et al. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. International journal of hygiene and environmental health. 2014;217(6):628-637.

4.         Jahn HJ, Schneider A, Breitner S, Eissner R, Wendisch M, Kramer A. Particulate matter pollution in the megacities of the Pearl River Delta, China - a systematic literature review and health risk assessment. International journal of hygiene and environmental health. 2011;214(4):281-295.

5.         Wyon DP. The effects of indoor air quality on performance and productivity. Indoor air. 2004;14 Suppl 7:92-101.

6.         Hirabayashi S, Nowak DJ. Comprehensive national database of tree effects on air quality and human health in the United States. Environmental pollution (Barking, Essex : 1987). 2016;215:48-57.
 

From Health Problems to Product Recalls, Poor Air Quality is the Culprit

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.  


Are you meeting clean-room sterility standards?

Creating a viable business decorum in the scientific and industrial manufacturing sectors often requires an area within your plant dedicated to sterile manufacturing.  Decisions regarding how your clean-rooms are set up, as well as the efficacy of the clean-rooms themselves, often coincide with how productive your company’s operations are.  It's no secret that attaining an optimal production ratio, while keeping quality and sterility at the forefront, significantly impacts your company’s bottom line.  Here, we outline why having properly functioning clean-rooms, as well as having reliable clean-room checking mechanisms, are important for your manufacturing regime.    

Background

In recent months, several laboratories have come under regulatory scrutiny due to contamination of their products.  In most of these cases, the laboratories involved were presumed to have been compliant with FDA, EPA and cGMP clean-room standards [7]. Given the marked frequency of the recent string of recalls, concerns have been raised regarding industry wide regulations which have been implemented as “metrics for evaluating products” through good manufacturing practices in the medical and industrial sectors [1]. Many industry analysts remain perplexed by these recalls given the years of significant investments that have gone into testing and clean-room technologies [6].  With these monetary and technological investments, coupled with stringent regulatory and clean-room standards, the overall prevalence of product recalls was expected to experience a significant reduction in the years to come [3].  However in recent years, the news trends points to a much different picture as “the amount of drug recall occurrences in the U.S. saw a general increase post-1998.” [1 ]
   

Though the stipulated reasons behind this rise in recalls can be attributed to many factors, recent studies have outlined two main causes that are found ubiquitously in all recalls:  "quality of dosage forms" and “the quality of product not conforming to the registered specifications” [1,8].  Given that most product recalls are attributed to one or both of these circumstances, a relationship between product quality and recall frequency was established where the overall quality of consumable products is enhanced through the efficacy and availability of clean-room manufacturing stations [9].  Thus, creating a culture where clean-room sterility is up to standard provides a significant advantage to manufacturers that can effectively prevent the vast majority of product recalls that laboratories and manufacturers may face [5].
     

Solution           

Currently, there are systems in place that are co-dependent on utilizing properly verified sterile laboratory clean-rooms[3,4]. These systems can only be properly implemented when these clean-rooms are routinely checked and verified by accredited testing laboratories that specialize in clean-room certifications.  Unfortunately, many manufacturers and laboratories choose to forgo proper clean-room certification as they assume the need is not there[7]. Notwithstanding, more and more studies are being published with “advanced molecular methods” that show “the microbial bioburden... of clean-rooms and other low-biomass environments” is increasingly diversifying despite utilization of standard in-house cleaning methodologies [2,4,5,8].  The current nature of the body of evidence distinctly shows the in-disposable nature of having clean-rooms certified by accredited laboratories [1].

Through proper implementation of current industry standards, coupled with proper clean-room certifications by accredited laboratories, laboratories and manufacturers will be able to observed a marked reduction in overall recall prevalence[1,5].  The current body of evidence, accompanied with the significant financial investments, provides industry producers a greater confidence with regards to their products that equates to an increase in “quality of dosage forms” and “the quality of product not conforming to the registered specifications”  [1]

At the forefront of clean-room certifications, Sure-BioChem Laboratories is an approved clean-room performance testing contractor that complies with all industry standards and is dedicated to ensuring successful certification outcomes. Our certification team has experience qualifying clean-rooms of all classes and applications. Experienced in scientific, industrial and ISO 3 to ISO 9 protocols, Sure-BioChem Laboratories' expertise in a wide variety of clean-room applications makes us a preferred source for competent clean-room certification in accordance to ISO 14644-1 and 2 specifications.  Our experienced team offers testing and certification of all classifications of ISO clean-rooms and anterooms including particle counting, HEPA filter integrity testing, airflow volume/velocity, room pressurization, temperature and humidity monitoring. 

     
Conclusion
            
Attaining a verifiable standard of clean-room sterility is often paramount to the success of any industrial and scientific manufacturing endeavor. Having your clean-room accredited by a verified laboratory significantly reduces the risk to your product and company.  Also, by keeping up with you clean-room accreditation, your company will be able to detect and rectify any underlying problems that my stem from clean-room sterility problems. For additional information regarding your clean-room sterility contact Sure-BioChem Laboratories at info@surebiochem.com for your clean-room consultation today.

 
REFERENCES

Cheah, Eng Tuck, Wen Li Chan, and Corinne Lin Lin Chieng. "The corporate social responsibility of pharmaceutical product recalls: An empirical examination of US and UK markets."Journal of Business Ethics4 (2007): 427-449.

Cooper, Moogega, et al. "Comparison of innovative molecular approaches and standard spore assays for assessment of surface cleanliness." Applied and environmental microbiology15 (2011): 5438-5444.

El-Nakeeb, M. A., A. M. Khalil, and A. F. Gasser. "Microbiological studies on bacterial isolates from penicillins filling cleanroom." New Egyptian Journal of Microbiology1 (2014): 87-110

La Duc, Myron T., et al. "Comprehensive census of bacteria in clean rooms by using DNA microarray and cloning methods." Applied and environmental microbiology20 (2009): 6559-6567.

La Duc, Myron T., et al. "Isolation and characterization of bacteria capable of tolerating the extreme conditions of clean room environments." Applied and environmental microbiology8 (2007): 2600-2611.

Nagarkar, Parag P., Satish D. Ravetkar, and Milind G. Watve. "Oligophilic bacteria as tools to monitor aseptic pharmaceutical production units." Applied and environmental microbiology3 (2001): 1371-1374.

Rieser, Gernot, Siegfried Scherer, and Mareike Wenning. "Naumannella halotolerans gen. nov., sp. nov., a Gram-positive coccus of the family Propionibacteriaceae isolated from a pharmaceutical clean room and from food." International journal of systematic and evolutionary microbiologyPt 12 (2012): 3042-3048.

Seiler, Herbert, Mareike Wenning, and Siegfried Scherer. "Domibacillus robiginosus gen. nov., sp. nov., isolated from a pharmaceutical clean room." International journal of systematic and evolutionary microbiology (2012): ijs-0.
Wu G. F., Liu X. H. (2007).


Feeling the compounding fiscal shortfalls of in-house testing?

Industry demands for complex and definitive testing protocols have increased over recent years. This new paradigm has put a strain on in- house testing laboratories by requiring them to conform to ever-changing, exacting, pharmacological standards established by industry oversight organizations. For many companies, their bottom line is negatively affected by the transient regulatory standards, and this often results in a fiscal drain for the company.

Compounding the fiscal shortfalls that in-house testing procedures may create, is the fact that many in-house laboratory protocol statements may suffer from reporting bias. Frequently, when testing protocols are conducted utilizing a company’s internal methods, there may be a misguided belief that their specific reporting schema will result in more favorable results. In other words, the laboratory, company or the employee themselves can produce better results because they know the product. However, this practice can lead to a tendency to under-report findings obtained using the company’s unique laboratory testing procedures, and consequently, skew the final testing results.

Many leading companies have shifted towards this new model of outsourcing testing protocols because verified testing laboratories can serve as a safeguard that ensures the continued growth of their company. Using verified testing laboratories also provides assurance that a company’s products are being examined through unbiased lens that are regulated by industry oversight organizations. In addition, if any discrepancies are detected in the samples, outsourced laboratories are typically in a better position to isolate and rectify any potential problems with a company’s product. The client would also be spared the burdensome process of conducting a complete audit of their entire laboratory protocol.

Considering the increasing level of industry guidelines, well-informed companies are contracting with certified testing laboratories to have testing results concurrently and accurately verified. Though not required, outsourcing helps provide a layer of protection for the company. More importantly, it also allows prospective companies to devote valuable fiscal and human capital to projects, which will result in the greatest return and increase the bottom line.

As a premier source of validated industry and laboratory testing, Sure-BioChem Laboratories continues to provide clients with testing services consistent with our belief of proactive prevention. Sure-BioChem’s experienced team offers a myriad of testing options for prospective companies that adheres to industry standards. We give our clients “Results they can be sure of”!

Contact Sure-BioChem Laboratories at 888-398-7247 for more information about our services.


How Salmonella DT104 defeats antibiotic after antibiotic

The enteric pathogen S. typhimurium has a phage-type known as DT104, which is associated with an epidemiology that is extensive and virulent. It was characterised about 30 years ago, and has spread to nearly all areas of the earth since then (2). S. typhimurium DT104 was found to have become resistant to multiple antibiotics in 1972 (2). This strain, now known as MDR-DT104, acquired the relevant mutation through the integration of an additional 43-kilobase genomic island (SGI1) into its genetic profile (3). In 1975, an alternative strain of DT104 also acquired multi-drug resistance in Thailand via different mechanisms (2). SGI1 confers resistance to a specific subset of antibiotics: sulphonamide-types, as well as tetracycline, streptomycin, chloramphenicol and ampicillin (3). However, some MDR-DT104 strains isolated in Britain were found to have added resistance to trimethoprim, (13%) ciprofloxacin (16%) or both (2%) to their anti-drug arsenal (1). In addition, some studies have reported evidence of resistance to ertapenem and ceftriaxone in some isolates (4). Ceftriaxone resistance may be conferred via transfer of the Incl1 plasmid, whereas enzymes such as IMP-4, IMP-13 and KPC-2 (that originate from E. coli) may be required to break down carbapenems (4). On the other hand, few studies have found these enzymes in any S. typhimurium phage-types (4).

MDR-DT104 is thought to have originated in Europe, where it was transmitted several times to a number of different countries therein. It then spread to Japan and to the U.S. in two separate transmission incidents, which may explain how it is also now present in Taiwan and Canada (2). However, other scientists conclude that MDR-DT104 actually originated in Southeast Asia, based on the presence of the rare ‘resistance’ genes tetG and floR (3). DT104 infects livestock such as cattle and poultry, and, subsequently, causes disease in the humans who consume them (1). The risk of drug-resistant salmonellosis is affected by several factors, including the handling of raw meat, consuming cheese made from unpasteurized milk, eating undercooked meat and (mostly in cases involving children) exposure to sand-pits while playing (1,5). The use of proton-pump inhibiting drugs and the antibiotics as listed above may also contribute to the risk of infection (2). MDR-DT104 is associated with several outbreaks among livestock in a number of countries, from the Republic of Ireland to the Philippines (2). It is also related to approximately 20,000 hospital visits and hundreds of deaths per year in the United States (2).

Historically, MDR-DT104 outbreaks have been addressed or prevented through treatment with quinolone-type antibiotics (1). However, evidence of some strains of the phage-type that have also acquired resistance to these drugs has surfaced (7). Quinolone-resistant DT104 (e.g. DT104B) strains are linked to new outbreaks with high mortality rates (6). A study of the subproteome of a clinical strain, DT104B-Se20, found seven proteins that were associated with this resistance, including familiar examples such as Omp subtypes (e.g. OmpD and OmpX) as well as the newly-discovered agent of resistance MipA (6). (Altered OmpD expression levels are also associated with carbapenem resistance (4). OmpC was also associated with the metabolic adaptations required for quinolone resistance, as were CheB, CheM, SodA and Fur (6). The clinical strain was also associated with certain proteins involved in lipopolysaccharide production (e.g. LptA and RfbF) (6). These interesting findings may form the basis for new research leading to new therapeutics or preventatives for infection with quinolone-resistant MDR-DT104.

References:

1. Threlfall EJ. Epidemic Salmonella typhimurium DT 104—a truly international multiresistant clone. Journal of Antimicrobial Chemotherapy. 2000;46(1):7-10.

2. Leekitcharoenphon P, Hendriksen RS, Le Hello S, et al. Global Genomic Epidemiology of Salmonella enterica Serovar Typhimurium DT104. Applied and environmental microbiology. 2016;82(8):2516-2526.

3. Mulvey MR, Boyd DA, Olson AB, Doublet B, Cloeckaert A. The genetics of Salmonella genomic island 1. Microbes and Infection. 2006;8(7):1915-1922.

4. Su LH, Wu TL, Chiu CH. Development of carbapenem resistance during therapy for non-typhoid Salmonella infection. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases. 2012;18(4):E91-94.

5. Doorduyn Y, Van Den Brandhof WE, Van Duynhoven YT, Wannet WJ, Van Pelt W. Risk factors for Salmonella Enteritidis and Typhimurium (DT104 and non-DT104) infections in The Netherlands: predominant roles for raw eggs in Enteritidis and sandboxes in Typhimurium infections. Epidemiology and infection. 2006;134(3):617-626.

6. Correia S, Hebraud M, Chafsey I, et al. Impacts of experimentally induced and clinically acquired quinolone resistance on the membrane and intracellular subproteomes of Salmonella Typhimurium DT104B. Journal of proteomics. 2016.

7. Voetsch AC, Van Gilder TJ, Angulo FJ, et al. FoodNet Estimate of the Burden of Illness Caused by Nontyphoidal Salmonella Infections in the United States. Clinical Infectious Diseases.         2004;38(Supplement 3):S127-S134.
 
Proactive Microbial Testing Increase after Discovery of Colistin Resistant Microbe

Antimicrobial resistance is a growing trend that's affecting the way we both monitor and treat an increasing number of microbial infections.  Over several decades, the persistent rise of these antimicrobial resistant microorganisms has spurred both the private and public sectors into finding possible methods to halt the continued spread of these resistant microbes [4].  Currently several drug resistant strains of common pathogens like Staph, Strep and E.coli continue to emerge [3,4].  Previously, as more and more of these drug resistant microbes emerged, a handful of potent antimicrobials called “antibiotics of last resort proved effective in containing the spread of these drug resistant pathogens [2].  

However, recently a strain of E.coli was found in a woman in Pennsylvania that’s resistant to colistin,  the last agent used to combat microbes that are resistant to the strongest antibiotics [2].  The discovery of this particular resistant strain of E.coli points to an increased rate of lateral gene transfer, which is the main mechanism that theses microbes gain resistance to antimicrobial compounds [3,4]. Its also been shown that random mutations contribute to the emergence of these antimicrobial resistant strains of bacteria, parasites and viruses albeit at a lower rate [3].

Though the prevalence of these drug resistant microbes remains comparatively low, decades of data show that these low levels of drug resistant microbes are liable to significantly increase moving forward [1,4].  As such, many companies and institutions in both the public and private spheres have adopted many of the preventative measures outlined by agencies like the World Health Organization (WHO) [1].  In these reports, it’s highly advised that companies and institutions, especially those in the biotech and pharmaceutical sectors, have frequent and protesting protocols in place to catch any prospective antimicrobial resistant microorganisms in their infancy before they pose a greater public health risk [1,2,4].

Further outlined within these preventative measures is the increased utilization of certified testing laboratories like Sure-BioChem Laboratories to aide in the frequent testing of these companies and institutions [1].  As an industry leader Sure-BioChem Laboratories specializes in providing the highest quality microbial testing and monitoring services year-round.  Our experienced team is trained in sterility and antimicrobial efficacy testing services based on industry standards.  With our commitment to quick and reliable results your company be assured of your production standards.

For additional information regarding our microbiological testing services, contact Sure-BioChem Laboratories at 888-398-7247.

References:

1."Antimicrobial Resistance." World Health Organization. N.p., Apr. 2015. Web. 08 June 2016.

2.The U.S. Military HIV Research Program (MHRP). "First discovery in United States of colistin resistance in a human E. coli infection." ScienceDaily. ScienceDaily, 26 May 2016. <www.sciencedaily.com/releases/2016/05/160526152033.htm>.

3.Kay E, Vogel TM, Bertolla F, Nalin R, Simonet P (July 2002). "In situ transfer of antibiotic resistance genes from transgenic (transplastomic) tobacco plants to bacteria".

4.Barlow M (2009). "What antimicrobial resistance has taught us about horizontal gene transfer". Methods in Molecular Biology (Clifton, N.J.). Methods in Molecular Biology 532: 397–411


Heavy Metal Toxins Lace Suburban Neighborhood

Heavy metals are undeniably a crucial element in many of today’s industrialized and developing economies. Unfortunately, heavy metals are also known to cause many despondent health related issues to people exposed to elevated levels of these compounds. Many of the symptoms associated with heavy metal poisoning like nausea, vomiting, diarrhea, hepatic cirrhosis and anemia are often mistaken for bacterial or viral pathogens [3]. Given how easily heavy metal poisoning can be mistaken for biotic pathogens, treatment for heavy metal poisoning often starts after permanent neurological and physical damage has occurred [3,4].

Recently, many heavy metal related contamination events have spurred public and governmental action on many aged water and wastewater infrastructure systems [2,3]. Though aged water and wastewater systems are responsible for some of the most prevalent contamination events, heavy metal contamination can also occur through a myriad of routes [5]. One of the more understated routes towards heavy metal contamination involves the inadequate clean up of irresponsible industrial processes that failed to meet the local, state and federal environmental standards [1,4,5]. Such a case occurred in an East Chicago housing complex where about 1,200 homeowners were forced to vacate their homes after dangerous levels of lead and other heavy metals were discovered in the soil underpinning this community [1,2].

Though detailed information regarding the EPA sanctioned relocation of these 1,200 homeowners is still scarce, it’s believed that the housing complex was built on a previously identified superfund site [2,3]. Information was provided by the EPA regarding this superfund site that this superfund site previously housed a lead smelting factory that was consequently shut down due to numerous EPA regulatory violations [1,4]. Under the Comprehensive Environmental Response, Compensation and Liability Act act of 1980, the site of the lead smelting factory was supposed to be adequately cleaned up of any potentially toxic compounds like heavy metals [2,3]. After the cleanup of this site there was supposed to be independent testing to assure that the cleanup process was completed under federal and local guidelines [1].

In the case of the lead contaminated East Chicago neighborhood, the cleanup and verification process was not adequately done before the superfund site was approved for construction [3]. As a result, independent developers built the subsequent housing complex on the site which was still laced with too high levels of heavy metal contaminated soil [4].

Due to the shocking prevalence of the these superfund sites and the attractiveness these remediated sites pose to land developers, ensuring that the soil, water and relevant infrastructure is in accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980 is both a public, legal and financial imperative [3,4]. As per EPA guidelines these sites must be independently tested to insure the heavy metal levels are well within safe parameters [5]. In accordance to these parameters the EPA advises that local governments have former superfund sites checked by a certified testing lab like Sure-Biochem Laboratories to ensure compliance with both state and federal regulations. Sure-BioChem Laboratories specializes in providing the highest quality environmental monitoring protocols and heavy testing. Achieving a verifiable standard of environmental safety not only benefits the neighborhood in question, but the surrounding community as well.

For additional information regarding your sterility and particulate matter monitoring services, contact Sure-BioChem Laboratories at 888-398-7247 for your particulate matter consultation today.

Reference:
1. http://www.nytimes.com/2016/08/31/us/lead-contamination-public-housing-east-Chicago-Indiana.html
2. http://www.chicagotribune.com/suburbs/post-tribune/news/ct-ptb-east-Chicago-cleanup-st-1003-20161002-story.html
3. Dimaio, VJ; Dimaio, SM; Garriott, JC; Simpson, P (1983). "A fatal case of lead poisoning due to a retained bullet". The American Journal of Forensic Medicine and Pathology. 4 (2): 165–9.
4. Patrick, L (2006). "Lead toxicity, a review of the literature. Part 1: Exposure, evaluation, and treatment". Alternative Medicine Review. 11 (1): 2–22.
5. Pokras, MA; Kneeland, MR (2008). "Lead poisoning: using transdisciplinary approaches to solve an ancient problem". EcoHealth. 5 (3): 379–85.


Residual Contamination of Hazardous Compounds in Construction Enviornments

In 1980, the EPA established the Superfund program in response to heightened levels of unregulated toxic dumping grounds near and around residential zones [4,7]. Through the Superfund program, the EPA is tasked with the assessment, mitigation and remediation of these sites, which often pose a public health risk to the surrounding communities due to the hazardous compounds that are associated with these sites. Although these site are reclaimed through remediation, many studies have shown that toxic compounds often have a propensity to leach into the soil and local groundwater sources long after remediation practices are finished. [5].
Oftentimes, Superfund sites are characterized by contamination of substances such as arsenic, lead, mercury, benzene, cadmium, vinyl chloride, trichloroethylene, free radicals and polycyclic aromatic hydrocarbons [3]. Consequently, through the diversity of potential contaminants, there can be differentiation in the methods of action of remediation techniques [1,3]. Selection of remediation techniques used in Superfund sites “can be a challenging task due to the uncertainty in assessment of level of contamination, high costs of remediation and the collateral impacts of the technique on the environment.” [6]. Although remediation techniques are numerous and often require specialized analysis for their implementation, the majority of remediation techniques often fit into five main categories:

(i) complete or substantial destruction/degradation of the pollutants, (ii) extraction of pollutants for further treatment or disposal, (iii) stabilization of pollutants in forms less mobile or toxic, (iv) separation of non-contaminated materials and their recycling from polluted materials that require further treatment and (v) containment of the polluted material to restrict exposure of the wider environment. [6].


Though the processes and technologies behind Superfund site remediation are continually improving, it is not uncommon to have the residual contaminants in the air, soil and water of surrounding communities after the the remediation processes are complete.
In the tri-state area, there are a shocking number of Superfund sites collectively totaling about 206 as of 2016. The breakdown of these sites follows with there being 100+ in New Jersey, 90+ in Pennsylvania and 16 in Delaware. Though many of these Superfund sites may have been cleared for reuse within the larger community, subsequent studies have shown that although levels of contaminants in soil “‘become less bioavailable, their total concentration in soils remains unchanged” [2]. Furthermore, complete removal of these contaminants is often precipitated through natural processes from plants; however, remediation in urban environments that have a noticeable absence of active plant life or have been shown to be “subject to leaching thereby causing groundwater contamination.” [2].
Given the continued rise of urbanization globally and nationally, many of these remediated Superfund sites often lie in areas that are ideal for future construction projects. As a result, prospective developers may not know of the health risks associated with residual contamination from these contaminated sites. Consequently, it is recommended as a matter of due diligence that environmental monitoring and testing be performed on all existing and planned development sites by certified testing laboratories like Sure-Biochem Laboratories. Sure-BioChem Laboratories specializes in providing the highest quality environmental testing and monitoring services year-round. Our experienced team is trained in producing verifiable testing services for for lead, manganese, arsenic, mercury and volatile organics in remediated or contaminated sites.


For additional information regarding our environmental monitoring services, contact Sure-BioChem Laboratories at 888-398-7247.

1. http://www.atsdr.cdc.gov/spl/
2. Bolan, Nanthi, et al. "Remediation of heavy metal (loid) s contaminated soils–to mobilize or to immobilize?." Journal of hazardous materials 266 (2014): 141-166.
3. Dela Cruz, Albert Leo N. et al. “Assessment of Environmentally Persistent Free Radicals in Soils and Sediments from Three Superfund Sites.” Environmental science. Processes & impacts 16.1 (2014): 44–52. PMC. Web. 27 Jan. 2016.
4. http://www.epa.gov/superfund/search-superfund-sites-where-you-live
5. Gomez, Sarah A. Saslow, et al. "A General Chemistry Assignment Analyzing Environmental Contamination for the DePue, IL, National Superfund Site."Journal of Chemical Education 92.4 (2014): 638-642.
6. Hashim, M. A., et al. "Remediation technologies for heavy metal contaminated groundwater." Journal of environmental management 92.10 (2011): 2355-2388.
7. http://www.nj.gov/dep/oqa/labcert.html