Sterility testing must be performed and be demonstrated throughout many stages of the production process of a biologic or viral vaccine.
BioOutsource offers sterility tests by Direct Inoculation and by Membrane Filtration to GMP regulations and in compliance with the European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and the Unites States Pharmacopoeia (USP) standards.
There are two options for sterility testing that BioOutsource provides: Membrane Filtration and Direct Inoculation. Prior to testing, the sample matrix should be qualified in the assay to examine any inhibitory effects; this is achieved by spiking the test material with representative test organisms at low concentrations and acceptable growth should be observed. The following organisms are suitable as model organisms: Aerobic bacteria- Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa; Anaerobic bacterium- Clostridium sporogenes and fungi Candida albicans, Aspergillus brasiliensis.
In the sterility test, two different media are used: fluid thioglycollate and soya-bean casein digest medium. The sample is inoculated into the growth media and the test is incubated for 14 days. BioOutsource is able to report the results of the assay with a Certificate of Analysis within 5 days of the final observations.
It should be noted that these sterility tests are not applicable for test articles that are not intended to be sterile; a Bioburden test should be used in this case.
BioOutsource can advise on the appropriate testing for your test material as well as sample number and volumes.
Ask our experts about your sterility testing requirements.