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Top 10 Tips for Sterility Test

Sterility test is the main test for the sterile products and it also takes a lot of time to complete. Repeat of the test can cause problem for the manufacturing unit due to long time taken in analysis. Some useful tips can help to conduct a error free test.
Sterility is a critical test in sterile pharmaceutical manufacturing. there are a lot of chances of errors in this test due to the requirement of highly aseptic conditions during the process. The analyst must be careful about the contamination during the handling of the sample and sterile equipment.

Following are some useful tips those must be followed by the analyst to minimize the chances of errors and retest.

Sterility Test 1. The sterility tests should be performed by qualified personnel. Personnel should be trained appropriately in all procedure including the examination and test of control containers. Sterility test method validation should be carried out for all products.

2. The supervisors should monitor the personnel to ensure that they follow the standard operating procedures. Also, there should be frequent re-certification to ensure up to date training and information.

3. For the sterility test facilities, it should be ensured for a clean room design. Aseptic conditions should be maintained under all conditions during sterility testing.

These conditions are set out as per the requirements for principles of installation and operational qualification for the manufacture of aseptic products.

4. Cleaning, sanitation, and disinfection are important in preventing contamination of the test samples. The processes involved include disinfecting samples and equipment to be used in the test suite. Care should be taken in ensuring chemical agents do not also contaminate the test samples. Rapid sterility testing can be used to get the results fast.

In other words, it should be ensured that the disinfectants are also free of microbial contamination. As the primary cautionary measure, it should be seen towards setting up standard sanitization and disinfection procedures.

5. Environmental monitoring is another of the tips that ensure the credibility of the sterility test. The aim of the monitoring is to detect microbial trends and take the appropriate cause of action. Detection of microbes in the analyst's gloved hands and the working platform is also important.

6. The selection of the samples should be random at the beginning, middle, and end of a batch. In the instance that an original test is invalidated, then samples for the repeat test should be collected at the same position of the previous samples and similar aseptic processing times.

7. The choice of the sterility test method depends on the pharmacopeia method used. Regardless, the membrane filtration of the product is the most preferred method. The filter should be pre-wetted followed by washing for (the recommended minimum number of washes) during analysis. Also, the filter should not be allowed to dry out between filtration steps.

8. While there are a variety of media types, it should be ensured that they are approved by approved suppliers. Alternatively, the media could be prepared following standard procedures. Also, it is important to allocate batch numbers and shelf life of the media. Growth promotion test should be done for the media used for sterility test.

9. Irrespective of the test method used whether filtration or direct inoculation, containers should be incubated for at least two weeks at temperatures specified by the corresponding method for the different media. The temperatures should be monitored and the monitoring devices often calibrated to maintain accuracy.

10. Negative test controls should be included in each of the tests to simulate operator manipulations. On the other hand, positive test controls should also be conducted to prove that the test is valid and gives positive results if the product has contamination

By following all of the above tips, you can perform a successful sterility test by direct inoculation or membrane filtration method.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. Sir I required more tips about sterility test


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