Monday, 26 June 2017

Microbiological monitoring of pharmaceutical water systems


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

For a copy please contact Tim Sandle



Posted by Dr. Tim Sandle