Summary:

Describes instructions for setting-up and operating the 60 L reactor. Covers initial set-up and cleaning of reactor, final set-up of reactor, equipment check, sanitizing reactor, flow calibration, gel addition, gel washing, reagent addition, removing samples, gel removal, and final cleaning of reactor. References Cleanroom Gowning SOP, 120002, and instrument Calibration System SOP, 110033.

Included Sections:

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

Included Attachments/Appendices:

Equipment Cleaning and Use Logsheet

About This Document:

This is not a generic template, it's a 14-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
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Who Will Benefit:

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