Full Description

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:

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Who Will Benefit:

Biologic Manufacturing PersonnelProcess Development PersonnelMethod Development Personnel

Product Details:

Edition: 1.0 Published: 08/01/2007 Number of Pages: 9