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5. Controlling the microbial environment
Controlling the microbiological contamination of a given environment requires the establishment, implementation and maintenance of a formalized system to continuously assess and control all factors likely to have an impact on the microbiological quality of this environment. It is based on standard NF EN ISO 14698-1, which describes the general principles and methods of biocontamination control in cleanrooms and related controlled environments.
5.1 Microbiological risk assessment
Potential microbiological hazards associated with a process, product or patient must be identified, i.e. all potential sources of contamination (air, water, surfaces, etc.) which may be the source of biological elements responsible for an undesirable effect.
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Controlling the microbial environment
Conclusion
Bibliography
Standards and norms
- Cleanrooms and related controlled environments. Biocontamination control – Part 1: General principles and methods - NF EN ISO 14698-1 - 03-04
- Health care facilities – Controlled environment zones. Requirements for airborne contamination control - NF S90-351 - 04-13
- Indoor air – Part 16: Mould detection and enumeration – Filtration sampling - NF ISO 16000-16 - 2009
- Indoor air – Part 17: Mould detection...
Regulations
European Good Manufacturing Practice (EuGMP). Specific guideline: LD.1 Manufacture of sterile medicinal products
European Pharmacopoeia 0169. 8th edition. Specifications for water for injections
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