DOXPUB 02-0016-SOP

Summary:

Describes the methods used to set-up, and operate the TRIO Chromatography System for use in antibody manufacturing. Applies to properly trained manufacturing personnel requiring the use of the Sepracor, TRIO Chromatography System for manufacturing purposes.

Included Sections:

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

Included Attachments/Appendices:

Trio Chromatography System Use and Maintenance Logsheet

About This Document:

This is not a generic template, it's a 8-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