standard published 08/01/2007 by Doxpub, Inc.
Summary:
Describes procedure used to verify the integrity of filters using the Sartorius Sartocheck BP-plus automatic integrity tester. Applicaable to filter capsules used for filtering aqueous solutions in product manufacturing. Includes provisions for filter capsules such as Millipore Millipak-20, Sartorius Sartbran-pH, Gelman Supor DCF, and others.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Filter Integrity Test Request Form
About This Document:
This is not a generic template, it's a 8-page procedure that was actually created and used in the Facilities & Equipment operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.
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