Sterility Testing

June 2016

The sterility testing, here the sterility means the condition of being sterile, and we all know what sterile is, free from bacteria and other microorganisms which can also be said anti-bacterial. But, the state that undertakes absolute sterility is generally too rough for the active components, and the meaning of sterility in context to medicinal product should be determined in functional terms.

Sterility testing in context to pharmaceutical, there is a container is marked as sterile when the possibility is less than one million that is infected with clone microorganism. As it is infeasible to open and examine each container of medicinal product, there are some samples representing the whole, it is being examined and taken at separate timing at filling operation, it should be used for monitor sterility. So, when there is few of a non-sterilized container in the huge set of lookalike containers then there is probability of finding the non-sterilized container is very low, because of this thing the sterility testing uses the process with more of sensitivity, generally there is incubation of samples in increase media promotion increasing with a broader range of microorganism where the repetition can be find out easily.

 Sterility also depends on legal measures that actually prevent contamination of materials, for example room cleaning technologies and practices for manufacturing goods. When the viral contaminations are examined, is normally specified for single product requirement which are basically more costly and complex. The sterility testing of WHO is applicable all over the board range of medicinal products which consist of vaccines, products related to blood, biotechnologies, etc.

Nowadays, there has been advancement being done in molecular biology techniques like nucleic acid amplification techniques (NAT). Yet there is wide general testing which are more preferred to find unknown contaminants, few specified viruses could be detected using NAT.


-Shubhra Ketan





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