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
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