Puretech GENESYS Water for Injection Systems
Puretech GenesysWFI opens a new chapter in water for injection (WFI) delivery. GenesysWFI thermal sanitisation purification units are designed and constructed to produce WFI in full compliance with cGMP guidelines as per FDA and EMEA, EP, JP and USP requirements for pharmaceutical, laboratory and medical applications. From softened water to point of use, Puretech GenesysWFI offers a true single source, multi-technology validated unit, for producing WFI.
Puretech has produced the GenesysWFI using the experience of operating the Genesys pure water (pw) systems over many years. Puretech PW systems were based on using reverse osmosis followed by continuous electrodeionisation and then a final filtration using a 6,000 NMWL ultrafilter. These systems have reliably been producing PW since 2004.assurance of performance and quality.
- Water for injections to USP, EP and JP
- Automatic hot water sanitisation
- Flexible outputs from 100 to 20,000 l/hr
- Designed for simple upgrading of production rate
- Provides constant monitoring of RO status and gives warning of requirement for cleaning
- Constructed from 316L stainless steel, orbitally welded, internal surface finish 0.5 Ra. Designed to ASME BPE
- Choice of sophisticated control systems with inbuilt data logging and paperless chart recorder
- GAMP and 21 CFR part 11 compliant
- Validation to regulatory and client standards
- Minimises waste water
- Flexible system integration with proven technologies
- Remote monitoring capability.