There are two principal test formats; the British and European pharmacopeias (which have been harmonised with the United States and Japanese pharmacopeias), and the ISO 11737:1 test method.   

The “pharmacopoeia” methods are primarily designed for testing medicinal products, but can also be applied to medical devices intended for clinical trials before the sterilisation process has been fully validated. The “ISO” method is specifically designed for validating the sterilisation process of medical devices.

Our consulting laboratory will assist you in determining how to test your product according to the standards set out by the relevant governing body. In general, liquid products are filtered through a membrane in a closed system, while a direct inoculation method is used to assess the sterility of solid medical devices. All products are tested for sterility in our clean-room facility.

Principle of test

Pharmacopoeia methods

The pharmacopoeia methods advocate that the membrane filtration method be used to test products wherever possible. Where there are solubility issues or antibiotic suspensions that are unable to be filtered, it is permissible to directly inoculate the product into the test medium.

ISO 11737:1 method

The ISO 11737:1 method differs from the pharmacopoeia methods by using 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 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 required incubation period has completed.

Sample requirements

Please contact our laboratory for assistance on sampling requirements. This can vary according to the nature of the product, batch size, and sterilisation method, etc.

Contact us