DOXPUB 09-0158-SOP

Summary:

Provides a procedure for performing endotoxin quantitation using the ThermoMax Microplate reader from Molecular Devices by the Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) method. Intended to be used for determination of endotoxin levels in water, media, bulk intermediates and final product. Covers instrument and analysis setip, microplate template setup, standard preparation, microplate preparation, lysate preparation, microplate inoculation and reading, results, inhibition/enhancement testing, and routine testing.

Included Sections:

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

Included Attachments/Appendices:

Thermomax Endotoxin Determination Logsheet

About This Document:

This is not a generic template, it's a 10-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