Sterility Tests

Sterility tests are performed to ensure that live contaminating microorganisms are not evident in a product. This test is performed by direct inoculation or membrane filtration methods and can be performed in an isolator or clean room environment.

Especially in the pharmaceutical industry, reliable sterility testing and the development or validation of product-specific methods are critical steps in the processes. For the pharmaceutical, biopharmaceutical and medical device industries, testing of cell lines, media, in-process and end-products is essential.

In the direct inoculation method, the test substance is inoculated directly into two types of media to allow detection of both aerobic and anaerobic microorganisms. After inoculation, both media types are incubated for 14 days with intermittent observations to detect evidence of microbial contamination and a final observation at the end of the testing period.

In the membrane filtration method, sterile, closed units, equal volumes of test samples are allowed to be filtration through two membrane filters at the same time. Samples are incubated for 14 days in two types of media to facilitate detection of both aerobic and anaerobic microorganisms.

Along with the sterility test, the bacteriostase fungistase test is also performed to assess whether the test substance inhibits the growth of microorganisms. Performing this test is necessary to confirm the sterility result and to confirm that there are no antimicrobial properties in the test object that would prevent the detection of microbial organisms during sterility testing.

Briefly, sterility testing is designed to determine the presence or absence of foreign living contaminating microorganisms in biological parenterals designed for human use (instruments inserted in the human body but not ingested).

The sterility test period is 14 days, which allows a suitable incubation period to detect slower growing microorganisms. Many bacterial and fungal organisms can be detected in a shorter incubation period, but some microorganisms require a longer incubation period to multiply.

Sterility testing is generally performed according to United States Pharmacopoeia USP71. This section explains how to perform sterility testing, including details of the methodology and how a product should be tested based on sample size and fill volume. An understanding of sterility testing is helpful in designing a validation process. Adequate and reliable sterility test data are an important quality assurance indicator. Sterility testing is a skillful process that must be performed by trained and qualified laboratory personnel.

Our organization also provides sterility testing services within the framework of national and international standards, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.