DOXPUB 03-0011-SOP

Summary:

Describes alarm messages that can be generated by the software controlling the 120 Liter Reactor, identifies the most likely cause(s) of each alarm, and describes the recommended actions necessary to handle the alarm. Intended to serve as a guide for the personnel responsible for operating and maintaining the 120 Liter Reactor when alarm messages are generated by the controlling software.

Included Sections:

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

Included Attachments/Appendices:

119 Liter Reactor Alarm and System Malfunction Logbook

About This Document:

This is not a generic template, it's a 5-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