DOXPUB 09-0118-SOP

Summary:

Describes a procedure for using the Millipore Steritest System for membrane filtration sterility testing of solutions and devices. Intended to be used for sterility testing raw materials and finished products. Covers general setup and loading procedures, prewetting the membranes, preparation devices and containers, testing devices and containers, rinsing, adding media to canisters, bulk sterility testing, and interpretation of results. Includes provisions for compliance with USP 23-NF 18 and 21 CFR Part 610.12.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Steritest Membrane Filtration Sterility Test Report

About This Document:

This is not a generic template, it's a 7-page procedure that was actually created and used in the Quality Control 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.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel