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.
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 . 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 . Many industry analysts remain perplexed by these recalls given the years of significant investments that have gone into testing and clean-room technologies . 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 . 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 . 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 .
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. 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 .
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” 
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.
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 firstname.lastname@example.org for your clean-room consultation today.
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.
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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.
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.
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 . 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 .
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 . 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 . 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.
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.