The sample is inoculated into media that support the growth of bacteria and fungi and incubated for several days, usually 14. If no growth appears, the sample meets the sterility specification. The methods are described in the pharmacopoeias, such as the US or European ones.
It is important to understand what it shows and what it does not. It shows the absence of detectable live microorganisms in the units tested. It does not detect endotoxins, which are remnants of dead bacteria and need their own test. And because a sample of the batch is tested, its reliability also depends on the manufacturing process being aseptic.
A closed vial's sterility is lost the moment it is punctured without proper technique; from then on, its preservation depends on handling and, where applicable, on the solvent's preservative.
Sterility and absence of endotoxins are two separate controls. A product can pass one and not the other, so it is worth knowing which ones have been performed.
Related terms
Learn it in depth at the Peptide University
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Definition for educational and scientific purposes. It is not medical advice or a recommendation for use. NeoPeptidos products are sold labelled for research use only (RUO).