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ISPE DACH Affiliate: WFI Handbook Download - USD
ISPE DACH Affiliate: WFI Handbook Download - USD
D/A/CH Affiliate: WFI Handbook (English Translation)
Discounted member price: 149.00
You could save 67.6%

The ISPE D/A/C/H Affiliate Handbook: Production of Water for Injection without Distillation was first published by the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate in March 2019 in German and has been translated into English. This Handbook has been prepared by authors exclusively from Europe and focuses on a European perspective on WFI production by non-distillation methods, however non-European regulations are mentioned to provide additional context. In the future, an additional global perspective is planned to be published by ISPE. The publication of the revised European Pharmacopoeia Monograph on the Production of Water for Injections (WFI) in April 2017 was the result of decades of discussions and analysis. Prior to this revision, distillation was the final step in WFI production. The European Medicines Agency also published a Q&A document that incorporates additional requirements on the production of ambient WFI systems. This ISPE Handbook presents membrane processes as an alternative to distillation for the production of WFI, offering regulatory compliance with technical and operational feasibility practices.

Member Price: $ 149.00
Non Member Price: $ 460.00