DOXPUB 02-0023-SOP

Summary:

Describes the method for assembling, cleaning, testing, and use of the Millipore Minitan System in manufacturing. Applies to the use of the Millipore Minitan System for manufacturing purposes. Covers setup and washing, integrity test, clean water flux, cleaning filters, preparing buffer exchange, preparation of antibody concentration, and washing Minitan hardware.

Included Sections:

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

Included Attachments/Appendices:

Minitan System Use and Maintenance Logsheet

About This Document:

This is not a generic template, it's a 7-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