Full 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:

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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: 12