DOXPUB 02-0052-SOP

Summary:

Describes a method for determining the titer of viable Poliomyelitis virus through the enumeration of plaques formed on a monolayer of sensitive target cells. Intended for use in routine testing of cell lines, cell line derived products and for the support of process validations of systems that claim to remove or inactivate Poliomyelitis virus.

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 6-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