DOXPUB 02-0056-SOP

Summary:

Describes the procedure for operating and maintaining the Cryoplus II Liquid N2 Freezer. Applies to all freezers containing inventory controlled material (i.e. working and master cellbanks). Covers front panel indicators and gauges, liquid nitrogen storage, transfering liquid nitrogen to dewars, and manual filling.

Included Sections:

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

Included Attachments/Appendices:

Cryoplus II Liquid Nitrogen Freezer Use and Maintenance Logsheet

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