GENESYS WFI Brochure
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Water For injectionsSystems for Injection Systems Water For Injection Systems

The ultimate in water for injection generation 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. Water for injections In April 2017 the European Pharmacopeia’s revised monograph for water...

Water For Injection Systems GenesysWFI 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. For GenesysWFI Puretech worked on increasing the robustness of the system and final water quality further to give the user peace of mind. The GenesysWFI has twin pass RO system with membrane degassing, continuous...

Design & construction features Membrane degasser Buffer tank High Pressure pump CEDI module High Pressure pump Ultrafiltration module(s) Trusted technology, safely implemented GenesysWFI is designed to generate water for Injections in accordance with the European, United States and Japanese Pharmacopieas. The system has been designed to meet the regulatory requirements and includes both hot water sanitisation and chemical sanitisation sequences to maintain low bioburden. Engineering and manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and...

Water For Injection Systems Softened water tank Softened water tank This 316L stainless vessel is used as a reservoir for sanitisation and can be used for the automatic CIP cycles. Reverse osmosis Two stages of reverse osmosis membranes in series are used to give optimal control of bioburden. RO technology involves using a variable speed pressure pump to force a portion of the feed water through semipermeable membranes. The permeate flow is kept constant, independent of variables such as the feed water temperature. Reverse osmosis Continuous electrodeionisation The water passing through the...

Online compliance monitoring The GenesysWFI includes continuous monitoring of conductivity at 4 points in the system and the unit can be supplied with online TOC and real time bacterial counting monitors to give maximum real time monitoring of the main specification indices. Control system The GenesysWFI utilises the latest technology with touch screen HMI to allow ease of operation and monitoring. The GenesysWFI allows control and monitoring from a single interface with data logging facilities and links to user systems e.g. BMS, DCS or SCADA. The GenesysWFI control system has the...

Water For Injection Systems Technical data Model (1) ctual flowrate dependent on feedwater temperature and site feed water quality. Each system is designed on client exact requirements A Other capacities are available upon request. Material specifications Feed water requirements • Softened water tank 316L stainless steel vessel • Reverse osmosis housings 316L stainless steel • CEDI LX FDA approved materials • Ultrafilters polysulfone/polyethersulfone • Pipework 316L stainless steel, orbitally welded, internal surface finish <0.5 µm Ra • Frame 304 stainless steel • Control cabinet 304...

Water For Injection Systems Head Office Newcastle Office Aztec House Perrywood Business Park Salfords, Redhill Surrey, England RH1 5DZ Hoults Yard Estate Walker Road Newcastle upon Tyne NE6 1AB sales@puretech.uk.com www.puretech.uk.com