Even though clean rooms are validated and their effectiveness is periodically monitored, the working conditions inside and the biological impact of factors outside the clean room on these systems should also be checked. For this reason, swap samples are taken from the air, surfaces (tables, equipment, etc.) and the clothes and hands of the working personnel to check the level of viable microorganisms.
RELEVANT STANDARDS
The results of biocontamination will have a positive or negative impact on the bioburden of products produced in the cleanroom. Therefore, product cleanliness is closely related to the cleanliness of the air, surface and personnel.
Standard in Use
ISO 14698-1 Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
ISO 14698-2 Cleanrooms and associated controlled environments — Biocontamination control– Part 2: Evaluation and interpretation of biocontamination data
GMP ANNEX-1
