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Process Water Testing |
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PROCESS WATER TESTING FOR PHARMACEUTICAL GMP PURPOSES:
BACKGROUND
Water intended for pharmaceutical purposes use must be examined for microbiological content. The assessment criterion is dependent on the intended use of the water, whether that be water for injection or purified water.
A suitable volume of water is filtered through a vacuum filtering system. Sterile disposable filter cups with sterile 0.45µm cellulose nitrate membrane are used in the process.
For total aerobic plate count, membranes are placed on TSA plates, for coliform testing on M-Endo agar and for pseudomonads, on pseudomonas agar base with CFC supplement agar plates.
Total aerobic plate count:
Coliform count: 100mls
Test description
Test Code
Turnaround time
Total aerobic plate count
TMW 111
5 days
Coliform count
TMW 111
3 – 5 days
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