DOXPUB 09-0055-SOP

Summary:

Provides the procedure for analyzing endotoxin indicator vials from Endosafe, Inc. used by in analyzing oven depyrogenation. Applies to the Lytzen depyrogenation oven. Includes instructions for Standard Preparation, Endotoxin Indicator Sample Preparation, Microplate Preparation, Lysate Preparation, Microplate Inoculation and Reading, and Interpreting Results.

Included Sections:

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

Included Attachments/Appendices:

Kinetic Turbidimetric Analysis Form for Endotoxin Indicator Vials

About This Document:

This is not a generic template, it's a 5-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