STANDARD OPERATING PROCEDURE Title: Procedure for Sterility Testing

1. Purpose
It is established to provide a standard procedure for “Sterility testing”.
2. Scope
It is applicable sterile products and raw materials.
3. Responsibilities
QC Manager
Microbiologist
4. Procedure
The following procedures are applicable for determining whether test sample complies with the pharmacopoeial test for sterility or not.
1. Membrane filtration method
2. Direct transfer method
Membrane filtration method:
• A suitable membrane filtration unit consists of an assembly, which makes easy, the aseptic handling of the test sample and allows the transfer of processed membrane to the sterile media, for incubation.
• A membrane suitable for sterility has a rating of 0.45µ and a diameter of 47mm approx.
• The membrane should wet prior to testing with D/water.
• The filtration unit and membrane must be sterilized and store to maintain the performance characteristic.
• Dissolve the material to be tested in the sterilized peptone buffer.
• Shake to dissolve.
• Pass through membrane filter unit.
• Divide the processed membrane into parts.
• One part is put into FTM and other into SDB media.
• Place the FTM in an incubator at temperature of 30o –35oC, while SDB media is incubated at 20o - 25oC for 14 days.

5. Interpretation of test results:
• When no microbial growth is observed the article passes the sterility test.
• When microbial growth is observed, and then repeats the process. If no growth is observed this time, the test sample passes the sterility test.
If the growth of the same physical appearance is observed, then repeat the test with double volume or weight of test sample.
• If the test sample is free from microbial growth this time, then material passes the test. But in case of growth of same physical appearance, the test sample is rejected.

6. Safety precautions:
1. For cleaning of sterile area before Sterility testing, follow SOP “Cleaning procedure for sterility room” GL/SOP/QC/030
2. For personnel safety measure, follow the instruction for entering in Sterility room, GL/SOP/QC/029