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:
- 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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 9
- File Size:
- 1 file , 490 KB