SEDL / STP / STP1260-EB / STP14706S

Validation of Filters Used for Sterilizing Liquids

Martin, JM
Senior Vice President, Marketing, Healthcare Group, Pall Ultrafine Filtration Company, East Hills, NY

Cole, S
Staff Scientist, Scientific and Laboratory Services, Pall Europe Ltd., Portsmouth,

Geerligs, G
Staff Scientist, Scientific and Laboratory Services, Pall GmbH, Frankfurt,

Howard, G
Associate Director, Scientific and Laboratory Services, Pall Corporation, Port Washington, NY

Jaenchen, R
Director, Scientific and Laboratory Services, Pall GmbH, Frankfurt,

Pages: 10    Published: Jan 1996

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Abstract

Validation of sterilizing grade filters in biopharmaceutical production is necessary to assure the filter's efficiency or performance as part of a process, and to ensure the safety and reliability of both the process and its end product. A review of different aspects of validating filters used for sterilizing liquids, taking into account potential influences of process conditions and product formulations is presented.