Viable count Measurement ISO Standard

mpfizer

Involved In Discussions
#1
Hi,

Is there any ISO / ASTM standard or relevant USP to measure viable counts in a clean room environment?

ISO 14644 -1 2015 has a table A.1 for sample locations depending upon the size of the clean room for particle count monitoring but there is no mention of frequency of particle count monitoring .As per table A.1 we have to sample 28 locations ( class 10k clean room ) so has this to be done every day?

Is there a similar table for viable count monitoring and its frequency for clean rooms.

Regards
Michelle
 
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indubioush

Quite Involved in Discussions
#2
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

However, these standards do not have specifications for clean room classification in the way the 14644 standard does. It is up to you as the manufacturer to define the acceptable level of viable particulate (CFUs).
 
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