Environmental monitoring in pharmaceutical industry was studied by using settle plate, air sampling, surface monitoring and personnel monitoring. These methods are commonly employed to collect the samples in pharmaceutical industry. The collected samples were incubated and predominant bacteria were isolated based on the colony morphology and identified by molecular characterisation. The PCR sequenced bi-directionally for seven isolates i.e, Micrococcus luteus, Bacillus sp, Bacillus Sp. Strain S3Sr84, Kocuria sp. LWYT2000(2016), Staphylococcus sp. Bca53(2016), Brevibacterium sanguinis strain CF52, Staphylococcus hominis strain HB14. Environmental monitoring statistical trend data will provide the process control and environmental isolate must be identified to understand their disinfectant susceptibility.
Cite this article:
Gunaseelan Ramaiyan, Viswanathan Thirumoorthy. Microbiological Evaluation of Clean Rooms in Pharmaceutical Industries and Molecular Characterization of Microbial Isolates. Research J. Pharm. and Tech. 2021; 14(1):337-343. doi: 10.5958/0974-360X.2021.00062.7
Gunaseelan Ramaiyan, Viswanathan Thirumoorthy. Microbiological Evaluation of Clean Rooms in Pharmaceutical Industries and Molecular Characterization of Microbial Isolates. Research J. Pharm. and Tech. 2021; 14(1):337-343. doi: 10.5958/0974-360X.2021.00062.7 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-1-62
1. Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities. WHO. [Cited 2012]. Available from: https://www.who.int/immunization_standards/vaccine_quality/env_monitoring_cleanrooms_final.pdf
2. Clean rooms and associated controlled environments-part I: classification of air cleanliness. ISO. 14644-1:2015. Available from: http://www. iso.org/iso/catalogue_detail.htm?csnumber= 25052.
3. Disinfectants and Antiseptics. United States Pharmacopeia 41- National Formulary 36. 2018: 7090.
4. Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. [Cited 2004]. Available from: https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf.
5. Rajesh KG. Role of Environmental Monitoring and Microbiological Testing during Manufacture of Sterile Drugs and Biologics. American pharmaceutical review. [ Cited 2014]. Available from: https://www. americanpharmaceuticalreview.com/ Featured-Articles/169384-Role-of-Environmental-Monitoring-and-Microbiological-Testing-During-Manufacture-of-Sterile-Drugs-and-Biologics/
6. Disinfectant Validation Procedure [Cited 2017]. Available from: https://pharmapathway.com/disinfectant-validation-procedure/
7. Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. Draft Guidance. 2003; 1-59.
8. Sandle, T. Environmental Monitoring in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi: Business Horizons,2011; pp293–326
9. Ljungqvist B and Reinmüller B. Interaction between air movements and the dispersion of contaminants: clean zones with unidirectional air flow. J Parenter Sci Technol. 1993; 47(2):60–69
10. Sandle, T. Environmental Monitoring in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi: Business Horizons,2011; pp293–326
11. Teske A, Wawer C, Muyzer G, Ramsing NB. Distribution of sulfate-reducing bacteria in a stratified fjord as evaluated by most-probable-number counts and denaturing gradient gel electrophoresis of PCR-amplified ribosomal DNA fragments Molecular Ecology Group, Max Planck Institute for Marine Microbiology, Bremen, Germany. Appl Environ Microbiol. 1996; 62(4):1405-15.
12. Angel LSB. Limitations of Microbial Environmental Monitoring Methods in Cleanrooms. [Cited 2018]. Available from: https://www.americanpharmaceuticalreview.com/Featured-Articles/349192-Limitations-of-Microbial-Environmental-Monitoring-Methods-in-Cleanrooms/
13. Manufacture of Sterile Medicinal Products. In EudraLex - The Rules Governing Medicinal Products in the European Union. 2008; 4. EU Guidelines to Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use - Annex 1.
14. Eric S K and Kate D. international Journal of Pharmaceutical Compounding. 2001; .5(4): 248.
15. Disinfectant validation [Cited 2008]. Available from: https:// www.europeanpharmaceuticalreview.com/article/1189/disinfectant-validation.
16. Luis J. Genomic. Microorganisms in the Environment and Their Relevance to Pharmaceutical Processes, Microbial Contamination Control in the Pharmaceutical Industry. Drugs and Pharmaceutical Sciences. 2004; 142: 1-131.
17. Cundell AM. Microbial identification strategies in the pharmaceutical industry. PDA J Pharm Sci Technol. 2006; 60(2):111-23.
18. Microbial characterization, identification, and strain typing United States Pharmacopeia 41- National Formulary 36. 2018: 1180.
19. Pasquarella C, Pitzurra O and Savino A.. The index of microbial air contamination. J Hosp Infec. 2000; 46(4): 241–256.
20. Sandle T. A Review of Cleanroom Microflora: Types, Trends, and Patterns, J. PDA J Pharm Sci Technol 2011; 65 (4):392-403.
21. Microbiological control and monitoring of aseptic processing environment. United States Pharmacopeia 41- National Formulary 36. 2018: 7312-7325.
22. Sandle T. Environmental Monitoring Risk Assessment. Journal GXP Compliance. 2006; 10 (2): 231-237.
23. York MK., Traylor MM, Hardy J.and Henry M. Biochemical tests for the identification of aerobic bacteria: optochin susceptibility test. Clinical Microbiology Procedures Handbook, 2nd ed. ASM Press (Washington DC): 2004: 22.214.171.124-126.96.36.199.
24. Wiley EO, Brooks DR., Siegel-Causey D and Funk VA. The Complete Cladist: A Primer of Phylogenetic Procedure. [Cited1991]. Available from: http://taxonomy.zoology.gla.ac.uk/ teaching/CompleatCladist.pdf