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Sterility Testing for Pharmaceutical Products

Sterility testing

All pharmaceutical products need to be of high quality and extensively safe to be used for patients by the medical staff. Else it can cause problems for the patients. Sterility testing ensures that the given product is appropriately sterile. So it can be sent for further use. These tests are crucial for quality control and assurance of complete sterility of the product. 

But before you opt for sterility testing of pharmaceutical products, you need to know everything about sterility and its tests.

What Is Sterility?

In general terms, sterility means the absence of any virus, bacteria, or other viable microorganisms. The same definition applies to pharmaceutical products, as they have to be free from any contamination to be sterile. Further, the sterile material should not facilitate the growth of any microorganisms on its surface. If it does, then it is not sterile. 

However, this state is not present from the very beginning of manufacturing. Instead, a process called sterilization must be followed in order to achieve sterility in any product. Unlike disinfection or sanitization, the procedure here includes the complete killing of any life form present on the product. 

The sterilization process is conducted just after the product is prepared. In case the stock is sent back for processing after sterilization, there will be chances of contamination. Plus, different products require different sterilization methods, depending on their nature and make. 

Sterility Testing of Pharmaceutical Products

It is not possible to examine the products for being sterile without proper sterility testing procedures. Sterility testing helps to analyze the given sample for whether it is completely sterile or not. This becomes crucial for two reasons:

  • To ensure that the given product is safe to be sent in the market and used by the patients for different purposes. 
  • To check if the followed sterilization process is actually working or not. 


Therefore, manufacturers can assure their product’s quality through sterility testing of pharmaceutical products. On the flip side, it may not be possible to check each sample from the lot for being sterile. For this reason, a few samples are taken from the stock and checked for sterility. If they seem right, the chances of finding contaminated products reduce significantly, and the lot is declared safe. 

Usually, certain microorganisms are introduced to the given sample of the product after checking for any already available life signs. The lot can not be declared safe if the introduced microorganism grows further. It implies that the product is not completely sterile, and it facilitates life growth. In this case, the sterilization process followed by the manufacturer has to be reviewed and improved so that no such problem occurs in the future. 

Sterility Testing Procedures at Laboratories

It is crucial to conduct all this sterility testing only under the supervision of professionals and in a contamination-proof laboratory. Otherwise, the microorganisms can get introduced to the product even at the sterility test phase. Hence, the results of the analysis will not be accurate and will cause complications. That is why these tests must be conducted in accredit labs to obtain a correct and thorough analysis of the product with reliable results. 

These labs are generally kept clean and free from any contaminations. For this reason, their environment becomes suitable for conducting sterility testing of pharmaceutical products. Plus, experts ensure that no problems occur before, during, or after the procedure. So you can remain stress-free. 

Sterility Testing at Our Lab

We have state-of-the-art laboratories where our expert staff conducts sterility testing of pharmaceutical products. We have been carrying out these tests in the industry for quite a long time, and we have always offered reliable services to all our clients. 

Moreover, our labs have been accredited by the authorities. It means we follow appropriate procedures and offer the correct results according to guidelines. So you can rely on us regarding all your sterility testing requirements. Our professionals can also assist you with the sterilization validation process, providing you everything just under one roof.  

In case you have any queries about our sterility testing procedures or want to opt for them, you can reach us through the given ‘Quick Query’ form or call us on +91-11-45754575. We will provide you with all the necessary details while keeping your individual sterility requirements into consideration. 


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