DOXPUB 02-0064-SOP

Summary:

Describes the method for assembling, cleaning, testing, and use of the Millipore Pellicon-2 System. Applies to the use of the Millipore Pellicon-2 System for manufacturing purposes. It is the responsibility of personnel involved in manufacturing requiring the use of the Millipore Pellicon-2 System to adhere to the procedures as written. Covers setup and washing, integrity testing, cleaning water flux, cleaning filters before use, preparing buffer exchange, and washing Pellicon hardware.

Included Sections:

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

Included Attachments/Appendices:

Pellicon-2 System Use and Maintenance Logsheet

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Bioprocessing 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:

• Biologic Manufacturing Personnel
• Process Development Personnel
• Method Development Personnel