Standard Operating Procedure for Sterility Testing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for performing sterility testing of pharmaceutical products to ensure they are free from viable microorganisms.

2) Scope

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

3) Responsibilities

3.1 Microbiologist
– Conduct sterility tests as per this SOP.
– Document and report test results accurately.
3.2 Laboratory Supervisor
– Ensure all testing procedures are followed.
– Review and approve sterility test records.
3.3 Quality Assurance (QA) Personnel
– Validate sterility 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 culture media and sterilize testing instruments.
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 membrane filtration or direct inoculation methods for sterility testing.
4.3.2 Incubate test samples in appropriate media at specified conditions (e.g., temperature, time).
4.4 Monitoring and Documentation
4.4.1 Monitor samples for microbial growth during the incubation period.
4.4.2 Record observations and test results in the Sterility Test Log.
4.5 Reporting
4.5.1 Compile test results and prepare a sterility 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 sterility test results to determine the source of contamination.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Sterility Test Log
– Sterility Test Reports
– Media Preparation Records

7) Reference, if any

– United States Pharmacopeia (USP) <71> Sterility Tests
– European Pharmacopoeia (Ph. Eur.) 2.6.1 Sterility

8) SOP Version

Version 1.0