What Is The Need For The European Pharmacopoeia Sterility Testing?

Sterility Test refers to the GMP microbiology test required to confirm that the product does not contain any kind of viable microorganisms. It is tested before the release and patient administration. How can you define the European pharmacopoeia sterility testing? Why is it important?

It helps in defining the freedom of the microorganisms that are viable which is present. That is why sterility tests are done with different methods that include broad sensitivity and the incubation of the growth samples.

To check the sterility test, you need to check if the added microorganisms have grown, and that needs to be observed within the 5 days for the fungi and 3 days for the bacteria.

Evident Viable contaminating microorganisms

• The test is essential, and it is required to ensure the viable contamination of the microorganism that is not evident in the product. It is the test conducted by the membrane filtration or the direct inoculation method.
• It does not matter what type of method you consider, whether direct or membrane filtration; it can be performed with the isolator or the clean room environment.

Confirm the sterile products

• Another reason it is essential to take the sterility test is that it helps confirm the sterile product. It is applied to the substance, preparations, and other things that need to be sterile.

• It is required to confirm the sterile product that does not contain any kind of microorganisms.