DOXPUB 02-0038-SOP PDF

Summary:

Describes a procedure for the determination of the concentration of ammonia in aqueous solution. Intended to be used for the determination of ammonia concentrations in the conditioned media from bioreactors or static cultures of mammalian cells. May also be used for other purposes as they are identified. Includes instructions for reconstitution of ammonia, preparation of samples,

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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Who Will Benefit:

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