DOXPUB 11-0122-SOP

Summary:

Describes procedures for operating and maintaining the Safetech Cleansphere CA100 bench top portable mini-cleanroom. Applicable to Safetech Cleansphere CA100 devices used to simulate cleanroom conditions while performing aseptic procedures such as pouring supernatant, changing bottles and filters, and changing media bags.

Included Sections:

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

Included Attachments/Appendices:

Cleanshere Maintenance Logsheet

About This Document:

This is not a generic template, it's a 4-page procedure that was actually created and used in the Facilities & Equipment 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:

• Manufacturing Personnel
• Facilities Managers
• Laboratory Personnel