Introduction to Sterility Testing in the Pharmaceutical Industry

When you pick up medicine from the pharmacy, you trust it’s clean and safe, right? That trust comes from various tests performed and certified by the quality control laboratory. One of those tests is sterility testing. Nobody wants to take a medicine if it’s full of germs. Sterility testing ensures that medicines are clean and safe to use. Let’s talk about why it’s so important.

What is Sterility Testing?

The term, “sterility” is defined as the absence of all viable microorganisms. Therefore, any product can be considered sterile, only if there are no viable microorganisms at all. Sterility is an absolute term, which means, a product can be claimed as either sterile or non-sterile. But a product can never be claimed as, 50% sterile, or almost sterile.

Sterility testing helps make sure medicines are free from harmful germs, like bacteria and fungi.

Many types of pharmaceutical products are required to be sterile depending on their routes of administration, such as eye drops and intravenous products. If such products are not sterile, it may harm the patient or may even lead to death.

Sterility is not the only test to confirm the product’s sterility and release into the market. Sterility test represents one set of data…