A sterility test is defined as a test that critically assesses whether a sterilized pharmaceutical product is free from contaminating microorganisms. Sterility tests should be performed under conditions designed to avoid accidental contamination of the product during test. Meanwhile, such particular precautions must not adversely affect any microbes that should be revealed in the test. Working environment wherein the sterility tests are carried out must be adequately monitored at regular intervals by sampling the air and the surface of the working area by performing necessary control tests.
Sterility testing is intimately associated with a statistical process wherein the portion of a batch is sampled randomly. Therefore, the sterility of the particular batch for actual usage depends on the ‘sample’ having passed the sterility testing. In case, the contamination is not quite uniform throughout the batch, random sampling cannot detect contamination with absolute certainty. Therefore, compliance with the tests for sterility individually cannot certify absolute assurance of freedom from microbial contamination. Nevertheless, greater assurance of sterility should invariably originate from reliable manufacturing procedures that strict compliance with Good Manufacturing Practices (GMPs).
Sterility Testing at Creative Animodel
The direct inoculation method is to inoculate the test samples to different types of culture media to allow for the detection of aerobic and anaerobic microorganisms. After inoculation, the culture media is incubated for 14 days under appropriate conditions. Intermittent observations and a final observation at the end of the testing period are both needed to detect evidence of microbial contamination.Membrane Filtration
The concept of membrane filtration is that the microorganisms are collected onto the surface of filter with 0.45 micron pore size. Then, the filter is segmented and transferred to appropriate culture media and incubated for 14 days. Fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM) are two types of test media. FTM is selected based upon its ability to support the growth of anaerobic and aerobic microorganisms. SCDM is selected based upon its ability to support a wide range of aerobic bacteria and fungi (i.e. yeasts and molds).
Creative Animodel is a leading CRO which has extensive experience to provide comprehensive sterility testing services. Our advanced technology platforms can assure high quality services with a time-efficient manner. If you have any needs, please don’t hesitate to contact us.