standard published 08/01/2007 by Doxpub, Inc.
Summary:
Describes a method of assembly, standardization and sterilization of the Cell pH arm Hollow Fiber Bioreactor for use in antibody manufacturing. Covers intra-capillary space (ICS) flowpath assembly, standardizing bioreactor, setting pH high and low limits, priming the bioreactor with WFP, standardizing the temperature probe, standardizing the feed rate, standardizing the recirculation rate, preparing accessory tubing, autoclaving the bioreactor, setting up the bioreactor, system startup and flush, pre-inoculation system check, system inoculation, cell inoculation, and shut down/tear down/regeneration.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Cell-Pharm Bioreactor Set-Up and Standardization Record
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.
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