Description
Summary:
The purpose of this document is to give instructions for operation of the 120 Liter Reactor. Covers instructions for preliminary operations, operation of the user interface, system start-up, emergecny shut-off, operating the reactor in manual or steam-in-place modes, operating the reactor using pre-programmed manufacturing processes, manual tasks (sample removal, reagent addition, etc), switching between pre-programmed and manual modes, alarms and error handling, and system shut-down.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
120L Reactor Cleaning and Use Logsheet
About This Document:
This is not a generic template, it's a 12-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:
- 12
- File Size:
- 1 file , 510 KB
