Water Quality Testing
Water is an essential raw material used by the pharmaceutical industry. It may be present as an excipient, or used for reconstitution of products, during production of the finished product or as a cleaning agent for rinsing vessels, and equipment.
As such water needs to be monitored as a raw material and the water system needs to be evaluated and monitored as part of GMP manufacturing process.
Bioburden testing requires total viable colony Counts at 37ºC and 22ºC.
Colony counts provide enumeration of the population of heterotrophic bacteria present in water supplies. These bacteria may have water as their natural habitat or may have originated from soil or vegetation. Positive colonies can be further analysed for species identification if required.
Whilst it is recognised that the methods employed will not enumerate all bacteria present, the colony count is regarded as a useful indicator for monitoring trends or detecting sudden changes in water quality.
Comparison of the counts obtained at 37ºC with those obtained at 22ºC can in some instances provide an early indication of deterioration in water quality.
Source BioScience provide water quality testing services from a variety of sources:
- Potable water
- In-house water systems
- Water for injection (WFI)
For further information and prices please contact us or call +44 (0)115 973 9012