Sterility Test

Sterility test; It is an analysis method used to prove that no living microorganisms are present in the sample. It is done to prove that a product is sterile.

In the sterility analysis carried out in our GMP laboratory in a Class B area, under a Class A cabinet, it is determined whether there are aerobic and anaerobic bacteria, fungi (mold, yeast) in the product.

Sterility testing is performed on medical devices, biomaterials, medicines, cosmetic products, cellular products, exosomes, mesotherapy products, etc. that are sterilized by autoclave, gamma, ethylene oxide, filtration or other sterilization methods. is applied.

At least 3 samples from the same LOT are required for sterility testing. The product is finalized and reported 14 days after it is analyzed.

Analysis is carried out in accordance with the current European Pharmacopoeia 2.6.1 and ISO11737-2.

You can use the following communication channels for detailed information and planning.

Specialist Bioengineering. Yesim Erdogan
Tel: 05301276494