In practice, BWT SEPTRON biosafe modules have demonstrated excellent performance in generating HPW with < 10 CFU/100 ml over many years. Nevertheless, approval of membrane-based processes to produce Water for Injection by amending the monographs in the European Pharmacopeia was the motivation for completely overhauling the module.
This analysis led to a complete redesign. As a result, the integrity of the ultrafiltration in the SEPTRON WFI module when installed has been tested and proven. Preventative replacement of the final membrane safety barrier is even safer and simpler then before.
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