Reliable sterility testing and the development or validation of product-specific methods are, for example, the most critical steps in the drug development process. In this context, a series of tests are carried out to support cell lines, media, in-process and final product tests for the pharmaceutical, biopharmaceutical and medical device industries.
Sterility testing is done to ensure that live contaminated microorganisms are not evident in a product. This test is performed by direct inoculation or membrane filtration methods and is done in an isolator or clean room environment.
In the direct inoculation method, the test product 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. Intermittent observations are made to detect evidence of microbial contamination and a final observation at the end of the testing period.
In the membrane filtration method, sterile and closed units allow simultaneous filtration of equal volumes of test samples through two membrane filters. Samples are incubated for 14 days in two types of media, facilitating the detection of both aerobic and anaerobic microorganisms.
Along with the sterility test, the bacteriostase fungistase test is also performed to evaluate whether the test product is inhibitory to the growth of microorganisms.
In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. There are also sterility testing services among the numerous tests carried out in this context.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
