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| home > pmps > summer 2003 > highly purified water production by subsequent ultrafiltration - guaranteed integrity |
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Pharmaceutical Manufacturing and Packing Sourcer
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Depending on the quantities being produced, membrane methods for the production of water in water for injection (WFI) quality permit cost savings in the pharmaceutical industry by a factor of 5.5 to 7.5 compared with distillation. It is easier and thus far cheaper to produce highly purified water (HPW) by reverse osmosis combined with electro-deionisation and a second reverse osmosis or an ultrafiltration stage. HPW, a new water quality introduced in June 2002, is physically and chemically identical to WFI in accordance with the European Parliament. It is typically used for the final rinsing of primary packing materials and for the non-sterile manufacture of ointments, liquids and suppositories. WFI produced by distillation is still mandatory for injection and infusion solutions used throughout Europe.
A water treatment system with a second reverse osmosis stage used for the production of HPW has an extremely low cut-off rate (MWCO) of less than 100 Dalton and thus provides good protection against micro-organisms and pyrogens. However, since no method exists for testing the integrity of such membranes, it is not possible to achieve the validation generally demanded in the pharmaceutical industry with systems based on this process technology.
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By Dieter Schuster, Sales and Export Manager of Christ GmbH, Germany and Christ AG, Aesch/Switzerland, and Dr John Hutcheson, Senior Manager with Christ-Kennicott Water Technology Ltd, UK
Dieter Schuster has worked for the Christ Water Technology Group since 1979. He is currently Sales and Export Manager in the Pharmaceuticals and Life Sciences Division of Christ GmbH, Germany and Christ AG, Aesch/Switzerland, both members of Austrian Best Water Technology Group (BWT).
Dieter specialises in all areas of pharmaceutical water treatment and holds a Diploma in Process Engineering.
Dr John Hutcheson is Senior Manager with Christ-Kennicott Water Technology Ltd, UK.
He has specialised in filtration technologies and water purification systems and has vast experience in pharma grade water treatment plants. He holds a PhD in Chemistry.
Before joining Christ he was General Manager of USF Ltd.
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