Biocontamination Validation & Tests

Biocontamination Validation & Tests

Although clean rooms are validated and activities are periodically monitored, the biological impact of internal working conditions and out-of-room factors on these systems should be checked. Therefore, the level of live microorganisms is controlled by taking swap samples from air, surfaces (table, equipment, etc.) and working personnel clothes and hands.

RELATED STANDARDS

Biocontamination results will have a positive or negative impact on the bioload of products produced in clean rooms. Therefore, product cleaning is closely related to the cleanliness of the air, surface and staff.

Standard Used

ISO 14698-1 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods

ISO 14698-2 Cleanrooms and associated with the controlled environmentsBiocontamination controlPart 2: Evaluation and interpretation of biocontamination data

GMP ANNEX-1