Sterility & Mycoplasma Testing

For bank release

Sterility and mycoplasma testing are the minimal assays to be performed as bank release testing. For both assays a method suitability (stasis testing/interference testing) is required once for each product. Method suitability must be repeated whenever there is a change in composition or in the method of manufacture that might affect mycoplasma or bacteria detection.

The sterility testing could be performed according to EP, JP, USP and ICH Q5D as well as 21 CFR compliant.

The mycoplasma testing is available in compliance with EP and USP either as traditional culture assay or for faster results a qPCR test.

A Range of Available In Vitro Tests

In Vitro Tests


Sterility Testing is performed to detect the presence of microbiological contaminations and is carried out under aseptic conditions using the Direct Transfer method. An Evaluation of each sample matrix is required once in the course of a Method Suitability to demonstrate that the sample isn’t bacteriostatic or fungistatic.

The sample is tested in two different broth to cover the detection of possible anaerobic bacteria as well as aerobic bacteria and fungi contaminations.


A Bioburden assay allows quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions and is used for microbial examination of non-sterile products only. A Method Suitability Testing must be performed at least once for each sample matrix to demonstrate that the sample does not inhibit the growth of microorganisms under the test conditions.

Mycoplasma by culture method

Mycoplasma Testing is traditionally performed as culture method combined with an indicator cell method to detect the presence of mycoplasma species but is now adays replaced by qPCR testing. The Culture method consist of culturing the sample on agar media directly, as well as inoculation of broth media with multiple subculture on agar media.

The indicator cell culture method is most common using Vero cells which are stained with a fluorescent dye to show possible contaminations. Mycoplasmastasis testing is performed at least once for each sample matrix to detect any presence of inhibitory substances which might affect the assay.

Mycoplasma by qPCR testing

The Mycoplasma qPCR assays are designed on the 16S rRNA gene and are performed according to the European and Japanese Pharmacopoeia. The Mycobacteria qPCR designed on the 16S rRNA gene and are performed according to the European Pharmacopoeia.

Mycoplasma is a bacteria that is also the smallest free-living organism. It is important to assure that cell substrates used for manufacturing are free of mycoplasmas.

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