DOXPUB 15-0049-SOP

Summary:

Describes method of operation of Cryomed 1010, a controlled rate freezer, to freeze cell material in a controlled fashion while generating a documented record of the freezing curve on the chart recorder. Applies to all cryopreservation of cell samples using the Cryomed 1010 controlled rate freezer. Includes instructions for setip, calibration, selecting and initiating freeze programs, preparation of cell samples, freezing and 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:

None

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Laboratory R&D 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:

• Process Development Personnel
• Method Development Personnel
• Quality Control Personnel