April 6, 2022 admin
Guide for Industrial Disinfection:
The food and pharmaceutical industries are the fastest growing sectors in the Indian market. For the integrity and growth of both of these sectors, the major compliance is the quality of products. These industries are well regulated by Indian and International standards and certifications like cGMP certification by US-FDA, ISI, ISO, FSSAI, HACCP, etc. All these certifications are mandatory for any pharmaceutical, food, and dairy products. To claim these certifications, industries need to follow the norms and hygiene standards in their manufacturing facilities. As the end products of both of these segments are consumed by the customer, the major focus is to safeguard the product from microbiological contaminants.
Disinfection is the key to asserting the quality of the product being manufactured. Looking back to history, the revoking of a finished drug product, Cholestyramine Resin USP in 1988 kindled the need for a contamination control protocol. According to 21 CFR 7.41 of FDA, the criteria for recalling a finished product is defined under three classes, of which Class III comprises the guideline for microbial contamination. A study shows that, in the tenure of five fiscal years 2000-2016, there was an average recall of 150 products each year (Miglani et al., 2021). This leads to a huge economic burden on the industry. Part 178 and 211 of 21CFR of US-FDA provide guidelines for sanitization solutions and cGMP for the food and pharmaceutical industry.
Biofilms and Spores: Enemies to the industry:
The microbial contamination observed in the manufacturing facilities is generally of bacterial spores, biofilm-forming bacteria, yeast, or moulds. The vegetative forms of bacteria are easy to eliminate with low-level disinfection. The major problem-causing factors are spores and biofilms. Bacterial spores are the dormant structures formed in adverse environmental conditions. The spores are resistant to various environmental factors as well as antimicrobial compounds. These spores can escape the disinfection procedures in the industrial facility and cause contamination of manufacturing batches. On the other hand, bacterial biofilms, which is the extracellular polymeric substance (EPS) secreted by a consortium of bacterial colonies, contaminate the surfaces or instruments in the industry. The EPS forms a protective layer around the bacterial colonies, which restricts the entry of disinfectants and in turn provides protection to the bacteria. This also serves as a major problem in manufacturing facilities. To overcome these challenges the use of specific disinfectants is recommended.
Safer disinfection in Food and Pharmaceutical industry:
The safety of disinfectants used in the food and pharmaceutical industry is as important as the disinfection process itself. The residual activity of disinfectant is mandatory for prolonged activity but the residual form should not contaminate the product in any form. The chemical contamination of the finished product is as harmful as the microbial contamination and needs to be focused on. The U.S Environmental Protection Agency (EPA) certifies the chemicals or substances used for disinfection, sanitization, or sterilization for their safety to the exposed human population. Therefore, while selecting a disinfectant for the food and pharmaceutical industry the chemical must be EPA registered. According to the safety concern, the disinfectant recommended for the food and pharmaceutical industry is the quaternary ammonium compounds.
Role of Quaternary Ammonium Compounds in industrial disinfection:
The Quaternary Ammonium compounds are most recommended and safe to use for disinfection in food processing and pharmaceutical manufacturing facilities. A study has validated that the QACs have better efficacy against vegetative bacteria as compared to the hypochlorite (Yim et al., 2021). The QACs are also EPA approved for their use in the pharmaceutical and food industry, which makes them safe for use. The residual activity of QAC after disinfection helps in achieving a prolonged effect. According to the European norms, several QACs are proven to have bactericidal, fungicidal, and virucidal activity. The QACs are membrane-active agents and interact with the cytoplasmic membrane of bacteria and the plasma membrane of yeast. The virucidal activity of QAC is exhibited due to its hydrophobic activity against lipid-containing viruses. The fifth-generation QAC formulations have proven effective against non-lipid viruses and spores (Gerba, 2015). A QAC, Didecyldimethylammoniumchloride (DDAC) can exhibit residual activity, which can potentially eliminate antimicrobial-resistant enterococci isolated from the poultry environment (Wieland et al., 2017). The residual efficacy of disinfectant is claimed to prove its effectiveness after the application of the disinfectant. The residual activity of the fifth generation QAC is greater on stainless steel and gave 6 Log reduction against L. monocytogenes ATCC 19111, E. coli ATCC 11303, S. Enteritidis ATCC 13076, and S. Typhimurium ATCC 14028 (Iñiguez-Moreno et al., 2018).
MEDNTEK R82 is a perfect fit for Industrial Disinfection:
MEDNTEK R82 is a fifth-generation Quaternary Ammonium Chloride, used for surface and environmental disinfection. The fifth-generation QAC is a combination of 60% of the fourth generation and 40% of the first and second-generation QAC. It can be used for surface disinfection as well as fogging, which makes it a multipurpose disinfectant. The composition comprises DDAC which has proven residual activity. The composition has EPA approval and also CDSCO certification for its efficiency against the Coronavirus. The product’s recommended use is in food processing units, pharmaceutical manufacturing, research and development laboratories, veterinary facilities, hospitals, etc.
• Gerba, C. P. (2015). Quaternary Ammonium Biocides: Efficacy in Application. Applied and Environmental Microbiology, 81(2), 464–469. https://doi.org/10.1128/AEM.02633-14
• Iñiguez-Moreno, M., Avila-Novoa, M. G., and Gutiérrez-Lomelí, M. (2018). Resistance of pathogenic and spoilage microorganisms to disinfectants in the presence of organic matter and their residual effect on stainless steel and polypropylene. Journal of Global Antimicrobial Resistance, 14, 197–201. https://doi.org/10.1016/j.jgar.2018.04.010
• Miglani, A., Saini, C., Musyuni, P., and Aggarwal, G. (2021). A review and analysis of product recall for pharmaceutical drug product. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 174113432110338. https://doi.org/10.1177/17411343211033887
• Wieland, N., Boss, J., Lettmann, S., Fritz, B., Schwaiger, K., Bauer, J., and Hölzel, C. S. (2017). Susceptibility to disinfectants in antimicrobial-resistant and -susceptible isolates of Escherichia coli, Enterococcus faecalis and Enterococcus faecium from poultry-ESBL/AmpC-phenotype of E. coli is not associated with resistance to a quaternary ammonium. Journal of Applied Microbiology, 122(6), 1508–1517. https://doi.org/10.1111/jam.13440
• Yim, J. H., Song, K. Y., Kim, H., Bae, D., Chon, J. W., and Seo, K. H. (2021). Effectiveness of calcium hypochlorite, quaternary ammonium compounds, and sodium hypochlorite in eliminating vegetative cells and spores of Bacillus anthracis surrogate. Journal of Veterinary Science, 22(1), e11. https://doi.org/10.4142/jvs.2021.22.e11
Glossary: • US-FDA- United States Food and Drug Administration • ISI- Indian Standards Institute • ISO- International Organization for Standardization • FSSAI- Food Safety and Standards Authority of India • HACCP- Hazard Analysis Critical Control Point • 21 CFR – Code of Federal Regulations Title 21 • cGMP- Current Good Manufacturing Practice