DOXPUB 02-0022-SOP

Summary:

Describes the general requirements for the equilibration and use of the disposable PD-10 Sephadex column. Applies to all small volume gel filtrations of IgM antibody and other molecules using a PD-10 Sephadex column.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 2-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.

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• Use it as a starting point for your own documentation project
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Who Will Benefit:

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