1. Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide guidance for Sterility Assurance Level (SAL) testing of sterile medical devices and products.
2. Scope:
This SOP covers the procedures for conducting SAL testing of sterile medical devices and products. The testing is carried out to ensure that the product is free from viable microorganisms.
3. Responsibilities:
3.1. The Quality Assurance department is responsible for developing, implementing, and maintaining this SOP.
3.2. The Production department is responsible for providing the samples for SAL testing.
3.3. The Microbiology department is responsible for conducting the SAL testing.
4. Materials:
4.1. Sterile sampling devices (e.g. swabs, pipettes, syringes).
4.2. Sterile transport media.
4.3. Incubators.
4.4. Sterility testing equipment (e.g. biological indicators, media fill tests).
5. Procedure:
5.1. Sampling:
5.1.1. Samples must be collected under aseptic conditions.
5.1.2. Sampling should be done at predetermined intervals and locations.
5.1.3. Samples should be collected from different parts of the product.
5.1.4. Samples should be collected in a volume sufficient for testing.
5.1.5. Samples should be transported to the microbiology laboratory as soon as possible.
5.2. Testing:
5.2.1. The samples should be subjected to appropriate microbiological testing.
5.2.2. The testing should be carried out using a validated method.
5.2.3. The testing should be carried out in a sterile environment.
5.2.4. Positive control samples should be included in the testing to ensure the validity of the test.
5.3. Interpretation of the results:
5.3.1. If no growth is observed in the samples tested, the product is considered sterile.
5.3.2. If growth is observed in the samples tested, the product is considered non-sterile.
6. Documentation:
6.1. All test results must be recorded and filed appropriately.
6.2. Any deviations from this SOP must be documented and investigated.
7. Conclusion:
SAL testing is a critical component of quality control for sterile medical devices and products. This SOP provides guidelines for conducting SAL testing to ensure that the product is free from viable microorganisms.