Standard Operating Procedure for Endotoxin Testing

Purpose:

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for testing the presence of endotoxins in pharmaceutical products, ensuring compliance with regulatory requirements and product safety standards.

Scope

This SOP applies to all personnel involved in endotoxin testing procedures within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing endotoxin testing according to the procedures outlined in this SOP.
• Production Personnel: Responsible for providing samples for endotoxin testing and ensuring proper documentation.

Procedure

1. Sample Preparation:
   • Obtain representative samples of the pharmaceutical product to be tested.
   • Prepare samples according to specified methods and dilutions, if required.
2. LAL Reagent Preparation:
   • Prepare Limulus Amebocyte Lysate (LAL) reagent according to manufacturer instructions.
   • Ensure proper storage and handling of LAL reagent to maintain its stability and effectiveness.
3. Testing Procedure:
   • Transfer samples and appropriate controls into LAL test tubes or microplates.
   • Add LAL reagent to each sample and control well.
   • Incubate the samples at the specified temperature for the recommended duration.
   • Record any gel formation or color change as a result of endotoxin presence.
4. Calculation of Endotoxin Levels:
   • Calculate the endotoxin levels in the samples based on the reaction observed and the dilution factor used.
   • Compare endotoxin levels with established acceptance criteria and regulatory limits.
5. Documentation and Reporting:
   • Document all test results, observations, and calculations accurately and legibly.
   • Report endotoxin testing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• LAL: Limulus Amebocyte Lysate
• QC: Quality Control

Documents

• Endotoxin Testing Records
• LAL Reagent Preparation Log
• Calculation Worksheets

Reference

United States Pharmacopoeia (USP) General Chapter Test for Bacterial Endotoxins

SOP Version

Version 1.0