Water is widely used in pharmaceutical
manufacturing; either as a raw material, as an ingredient, or as a final
product. Water is also used for rinsing equipment or for the preparation of
disinfectants and detergents. These applications require water of
pharmaceutical grade to be used. This is water that has been through a chemical
purification step. Purification is undertaken so that the water is free of
substances that might cause interaction with drug substances, as well as to
obtain water of an appropriate microbiological standard.
Tim Sandle has written a review article
for monitoring pharmaceutical water systems for European Pharmaceutical Review.
Here is the abstract:
“Microbiological risks are ever present
with water systems; risks can arise through poorly maintained water generation
systems; through badly designed distribution networks (such as the presence of
deadlegs); or at user outlets (where ineffective tubing management can lead to
contamination). Weaknesses in water systems are exacerbated by microorganisms
being ubiquitous and varied in their ability to survive and grow under
different conditions. This means that the monitoring of pharmaceutical grade
water systems for bioburden is important. This article assesses the different
approaches that can be taken for the microbiological assessment of
pharmaceutical water systems, examining both cultural based methods and
alternative methods, arguing that rapid methods offer significant advantages.”
The reference is:
Sandle, T. (2017) Microbiological monitoring of
pharmaceutical water systems, European
Pharmaceutical Review, 22 (2): 25-27
Posted by Dr. Tim Sandle
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