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Rapid Microbiology is accelerating time to data for in-process monitoring. Water systems - particularly Purified Water (PW) systems are a good example of this. But why?
Water For Injection (WFI) is normally sterile, with very low endotoxin levels. The United States Pharmacopeia (USP) defines the objective of monitoring WFI as to demonstrate that water quality is as expected. Microbiological data should therefore be demonstrating that at point of use, the expected water quality is delivered.
PW systems normally have a low bioburden - this may drift for varying reasons, therefore data showing an adverse trend early on is even more critical.
A recent article by Dr Eric Bagur from Bristol-Myers Squibb in France entitled 'Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing' published in European Pharmaceutical Review
covers both situations. The Pallchek™ Rapid Microbiology System was used to monitor production quality of functionally sterile water (e.g. WFI) and for PW. The author provides testing procedures with examples of how data obtained can be interpreted and used for quality assurance and control.
The simple, clear guidance provided in this paper can quickly and easily be applied to most water systems.
The paper can be viewed at: http://www.pall.com/biopharm_49930.asp