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Sterility Tests |
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BACKGROUND:
Sterility Testing is used to demonstrate that a medicinal product or medical device is sterile. There are two principal test formats. The British and European Pharmacopeias, which have been harmonized with the
Our consulting laboratory will assist you in determining how to test your product according to the governing standards for these tests.
Products are generally filtered through a membrane in a closed system if they are liquids, and for solid medical devices and other such products a direct inoculation method is used to test the product for sterility. All products are tested for sterility in clean-room facilities.
PRINCIPLE OF TEST:
The pharmacopoeia methods advocate whether possible that the membrane filtration method be used to test the product. Where there are solubility issues or antibiotic suspensions that are unable to be filtered, it is allowed to use direct inoculation of the test medium as the test method.
Whichever method is selected it is necessary to qualify the procedure by demonstrating the ability of a prescribed range of microorganisms to grow in the media after the product has been set-up for test.
The ISO 11737:1 method differs from the pharmacopoeia methods by utilizing just one medium type and setting up the test articles as individual tests, rather than combining into a composite sample.
It is necessary to qualify the procedure by demonstrating that the test articles to do not impart any anti-microbial growth properties to the test medium. This is done by inoculating a representative proportion of the test media with low numbers of prescribed microorganisms to demonstrate their ability to grow in the media after the product has been set-up for test.
Contact the laboratory. This can vary according to the nature of the product, batch size, sterilization method, etc.
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