DOXPUB 03-0014-SOP

Summary:

Describes the procedure and materials required in the assembly of tubing used to fill columns with gel from both bench and table situations. Applies to the tubing used in the various gel filling events such as; Avidin or Carboxyl gel and PBS transfer, processing and dispensing of gel and PBS. Covers assembly of column filling set, assembling of carboy supernatant removal line, assembly of PBS and Gel Degassing/Transfer Line, and assembly of the vessel PBS lines.

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 3-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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Who Will Benefit:

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