CLEAN ROOM PERSONNEL CONTROLS

In the clean room, microbiological samples are taken from the hand surfaces of personnel working in critical areas and in contact with the product using transport swabs for analysis and evaluation.

The microbiological analyses being evaluated include Total coliform bacteria, Escherichia coli, and Staphylococcus aureus.

In some cases, Aerobic mesophilic bacteria are also sampled.

The evaluation methods and standards are as follows:

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