DOXPUB 09-0032-SOP

DOXPUB 09-0032-SOP
DOXPUB 09-0032-SOP English PDF Endotoxin Determination Using LAL Gel Clot Method

standard published 08/01/2007 by Doxpub, Inc.

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Full Description

Summary:

Provides the procedure for detecting endotoxin levels in aqueous solutions using Limulus Amebocyte Lysate (LAL) gel clot method. Includes provisions for sample handling, endotoxin control, operation, reading reactions, calculating results, reagent qualification and extraction.

Included Sections:

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

Included Attachments/Appendices:

LAL Test Results Worksheet

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:

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Who Will Benefit:

Quality Assurance ManagersManufacturing ManagersQuality Control Personnel

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