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 United States and Japanese Pharmacopeias, and ISO 11737:1 test method. The “pharmacopoeia” methods are usually used for testing medicinal products but may also be used for checking medical devices to be used for clinical trial purposes before the method of sterilization has been fully validated. The “ISO” method is used when validating a sterilization process for a medical device.
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 our clean-room facility.
PRINCIPLE OF TESTS:
1. Pharmacopoeia Methods
The pharmacopoeia methods advocate wherever 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 allowable to directly inoculate the product into 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.
2. ISO 11737 Method
The ISO 11737 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 required incubation period has completed.
- Current BP Appendix XVI A/EP Supplement 2.6.1
- ISO 11737-2:2009 (E): Sterilisation of Medical Devices – Microbiological Methods, Part 2.
- EU Guide to GMP for Medicinal Products, Annex 1- Manufacture of Sterile Medicinal Products.
- USP <71> Sterility Test.
Please contact our laboratory for assistance on sampling requirements. This can vary according to the nature of the product, batch size, sterilization method, etc as shown below.
Table 2 below shows the sampling schedule that clients will need to provide. (Table is taken from TGA Guidelines for Sterility Testing of Therapeutic Goods - 2006)
Table 3 below shows the minimum quantity that needs to be tested by the testing laboratory. (Table is taken from TGA Guidelines for Sterility Testing of Therapeutic Goods - 2006)