DOXPUB 03-0004-SOP

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