Procedure for Sterility Testing

1) Purpose

The purpose of this SOP is to outline the procedure for performing sterility testing on pharmaceutical products to ensure they are free from viable microorganisms and safe for patient use.

2) Scope

This SOP applies to all pharmaceutical products manufactured within the facility that require sterility testing as per regulatory requirements.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting sterility testing and ensuring compliance with this SOP.
Microbiology Laboratory: Responsible for performing sterility testing procedures and maintaining sterile testing conditions.

4) Procedure

4.1 Equipment and Media Preparation:
    4.1.1 Prepare the sterile testing environment, including laminar flow hoods and incubators.
    4.1.2 Sterilize all equipment, including filtration units and sample containers, as per validated procedures.
    4.1.3 Prepare growth media suitable for sterility testing, ensuring sterility and suitability for the product type.

4.2 Sample Collection and Preparation:
    4.2.1 Obtain representative samples of the pharmaceutical product from the production department.
    4.2.2 Transfer samples aseptically into sterile containers suitable for testing.
    4.2.3 Ensure samples are appropriately labeled and documented to maintain traceability.

4.3 Sterility Testing Procedure:
    4.3.1 Perform membrane filtration or direct inoculation method based on product characteristics and validated procedures.
    4.3.2 Filter the sample through a sterilized membrane or directly inoculate growth media with sample.
    4.3.3 Incubate the inoculated media under appropriate conditions to promote microbial growth.
    4.3.4 Monitor incubated media for microbial growth over the specified incubation period.

4.4 Examination and Interpretation:
    4.4.1 Examine inoculated media for evidence of microbial growth, using appropriate microbial identification techniques.
    4.4.2 Interpret test results based on comparison with growth controls and acceptance criteria.
    4.4.3 Document any growth observed and classify samples as either sterile or non-sterile based on results.

4.5 Acceptance Criteria:
    4.5.1 Pharmaceutical products are considered sterile if no microbial growth is observed during the incubation period.
    4.5.2 Ensure all positive and negative controls demonstrate appropriate responses within established limits.

4.6 Documentation:
    4.6.1 Record all sterility testing procedures, results, and observations in the Sterility Testing Record.
    4.6.2 Maintain detailed records of sample handling, incubation conditions, and any deviations encountered.
    4.6.3 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Sterility Testing Record
Validation Report for Sterility Testing Method
Sampling Plan Document

7) Reference, if any

USP General Chapter <71> – Sterility Tests
Pharmacopeial standards for Sterility Testing

8) SOP Version

Version 1.0