DOXPUB 03-0005-SOP

Summary:

Provides the procedure for the set-up and Steam-In-Place (SIP) of the 120 Liter Reactor. Covers sanitization of filter assemblies, sanitization of accessories and single-use tubing, SIP of the 120L Reactor, set-up of the 120L reactor and a diagram of the vacuum and clean-steam circuits on the reactor.

Included Sections:

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

Included Attachments/Appendices:

Steam-In-Place (SIP) Check-List

About This Document:

This is not a generic template, it's a 9-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
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

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