The sterility of cell lines, media, in-process material and final products must be demonstrated during the manufacture of biopharmaceuticals. We conduct sterility testing in our GMP compliant facility in compliance with pharmacopeial standards.
Testing is carried out by the Direct Inoculation Method and the test article is added directly to growth media and incubated. The assay duration is typically 14 days up to a maximum of 21 days depending on the sample type.
Prior to conducting a sterility assay, a qualification assay is carried out to test for any bacteriostatic or antimicrobial substances in the test article. This is undertaken at the start of a production or process run and would not require to be performed again unless there have been changes in the production process.
Please contact us to discuss sample volumes required for different sample types.