PERSONNEL CONTROLS

PERSONNEL CONTROLS WORKING IN THE CLEAN ROOM

In the clean room, samples are taken from the hand surface of the personnel who come into contact with the product and work in the critical area with a transport swab for microbiological analysis and are evaluated.

Microbiological analyzes evaluated; Total coliform bacteria are Escherichia coli and Staphylococcus aureus.

In some cases, aerobic mesophilic bacteria are also sampled.

Evaluation methods and standards are given below.

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