Purified water is critical to the pharmaceutical industries, in operations ranging from formulating drugs to rinsing glassware. The bigger the operation, the more purified water will be needed. Considering just a few specific applications within pharmaceutical development – cell culture, media preparation, DNA sequencing and genome research – illustrates the crucial need for purified water of the highest quality. So that these and other processes can be carried out safely and effectively – and be fully validated – water has to be purified to approved standards. Pharmaceutical companies are experts in their fields, so it makes sense to outsource the critical job of water management to an equivalent expert.
When developing a water purification system from scratch or making the step from low volume laboratory trials to batch or full production, it helps to have a clear understanding of the critical phases involved
In the pharma sector, water quality is regulated by national and international bodies, specifying three commonly used grades of water: United States Pharmacopoeia (USP) specifies two grades – purified water (PW) and water for injection (WFI); while European Pharmacopoeia (EP) specifies an additional grade – highly purified water (HPW).
These rules outline specific parameters and measuring criteria for the water used in certain applications, but do not typically detail the system design considerations or maintenance regimes needed to achieve these quality levels. Instead, this falls within the remit of validating bodies, such as the US Food and Drug Administration (FDA), which aim to ensure compliance with standards by checking that system design, installation, monitoring and maintenance procedures are in place to facilitate consistent, traceable performance to the relevant standards.
In addition to these organisations, documents such as the current Good Manufacturing Practice (cGMP) and the ISPE Water and Steam Guide can help organisations with purified water requirements.
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