Pharmaceutical Water Testing
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.
The tests are conducted in accordance with the British Pharmacopoeia by membrane filtration.
PRINCIPLE OF TEST:
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 forpseudomonads, on pseudomonas agar base with CFC supplement agar plates.
Any presumptive typical growth from the above is confirmed by the use of suitable confirmatory tests.
METHOD REFERENCE:
- Current BP – Purified Water Monograph, Highly Purified and Water for Injection Monograph
SAMPLE REQUIREMENTS:
Total Aerobic Plate count: 200ml (WFI), 100ml (Purified Water)
Coliform count: 100ml
Pseudomonads count: 100ml
| Method Code | Test Description | Turnaround Time |
|---|---|---|
| TMW-111 | Total Aerobic Plate count | 5 Working Days (WD) |
| TMW-111 | Coliform count | 5 Working Days (WD) |