Standard Operating Procedure for Endotoxin Testing

1) Purpose

The purpose of this SOP is to outline the procedures for performing endotoxin testing on pharmaceutical products to ensure they are free from pyrogenic contamination.

2) Scope

This SOP applies to all pharmaceutical products that require endotoxin testing within the facility, including raw materials, in-process samples, and finished products.

3) Responsibilities

3.1 Microbiologist
– Perform endotoxin tests as per this SOP.
– Document and report test results accurately.
3.2 Laboratory Supervisor
– Ensure all testing procedures are followed.
– Review and approve endotoxin test records.
3.3 Quality Assurance (QA) Personnel
– Validate endotoxin testing methods.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the testing area and equipment.
4.1.2 Prepare reagents and standards as specified in the test method.
4.2 Sampling
4.2.1 Collect samples aseptically to prevent contamination.
4.2.2 Transport samples to the testing area in sterile containers.
4.3 Testing Methods
4.3.1 Use the Limulus Amebocyte Lysate (LAL) test method for endotoxin detection.
4.3.2 Prepare test samples, positive controls, and negative controls according to the LAL test kit instructions.
4.3.3 Incubate test samples and controls at specified conditions (e.g., temperature, time).
4.4 Monitoring and Documentation
4.4.1 Monitor samples for endotoxin levels during the incubation period.
4.4.2 Record observations and test results in the Endotoxin Test Log.
4.5 Reporting
4.5.1 Compile test results and prepare an endotoxin test report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Failures
4.6.1 Investigate any positive endotoxin test results to determine the source of contamination.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– LAL: Limulus Amebocyte Lysate
– QA: Quality Assurance

6) Documents, if any

– Endotoxin Test Log
– Endotoxin Test Reports
– Reagent Preparation Records

7) Reference, if any

– United States Pharmacopeia (USP) <85> Bacterial Endotoxins Test
– European Pharmacopoeia (Ph. Eur.) 2.6.14 Bacterial Endotoxins

8) SOP Version

Version 1.0