DOXPUB 09-0033-SOP

Summary:

Provides the procedure for transferring into media and incubating Bacillus pumilus and Bacillus stearothermophilus biological indicator spore strips. Applies to products that are terminally sterilized by E-Beam and Co60 (gamma) radiation and contain a Bacillus pumilis spore strip as a biological indicator of sterilization. Also applies to all lab ware, vials and implements that are sterilized by steam (autoclave) and contain a Bacillus stearothermophilus spore strip as a biological indicator of sterilization.

Included Sections:

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

Included Attachments/Appendices:

Biological Indicator Test Report Form

About This Document:

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

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel