The Transition to Ambient WFI Generation by the European Pharmacopoeia

Ambient WFI Generation

For many years, the prescribed method of WFI generation by the European Pharmacopoeia included only for distillation. Distillation was typically paired with a distribution system operating at elevated temperatures. The challenge for most WFI users was that the stored and distributed water needed to be cooled for use. This combined with the energy needed to run distillation plants effectively led to an energy inefficient process.

By contrast the United States Pharmacopoeia had already deemed technologies other than distillation as acceptable for the generation of WFI. Therefore, they were able to present a proven track record detailing the safe and effective generation of WFI using alternative technologies.

The move by the European Pharmacopoeia, in early 2000s, to create the classification of “Highly Purified Water” was seen by most as an interim step to the approval of non-distillation based WFI generation. HPW, while having the same specifications as WFI, was permitted to be generated using alternative technologies, but was for selected use within the Pharmaceutical industry, mostly in the manufacture of APIs.

In April 2017, the much anticipated review of the monographs (0169) by the European Pharmacopoeia was published, which allowed for the use on non-distillation based technology for the purposes of WFI generation.

The significant benefits offered by the revision to WFI users are:

Energy Efficiency
Essentially, the non-distillation technologies use combinations of membrane and electro-deionisation technologies all of which generate WFI quality water at ambient temperatures. As a result, the heating and cooling elements used for the operation of distillation systems are no longer required.

Vicol Approach
Vicol has significant experience in the application of non-distillation based technologies within the pharmaceutical industry. Vicol has successfully built and commissioned numerous treatment plants complying with the USP specifications for both PW and WFI.

Drawing on this experience and based on information shared with international technology partners, Vicol engineers have designed a robust treatment approach. This approach combines Reverse Osmosis technology in a heat sanitisable format with the option of the inclusion of a pharma-compliant electro-deionisation module and integrated with a final ultra-filtration step to ensure consistent WFI generation.

The resultant treatment system conforms to the regulations and guidelines of the USP and EP and draws on reference publications as expressed in the ISPE. This results in a qualified system meeting the requirements of international and local regulatory bodies, such as SAHPRA.

Cost Effective
WFI can now be generated more cost-effectively since the utility requirements typical of distillation plants are no longer required.

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