Disinfectant Efficacy Testing
Disinfectant efficacy testing is the mainstay of our business and we are primarily guided by the European Norms.
We have 23 Europena Norms listed under the scope of ISO/IEC 17025 accreditation for disinfectant efficacy testing.
EN 14885:2015 stipulates the European standards (or more specifically, laboratory test methods) to which chemical disinfectants and antiseptics must conform in order to support the claims for microbiocidal activity. It is applicable to all products that claim efficacy against vegetative bacteria (including mycobacteria and Legionella), yeasts, fungal spores, viruses (including bacteriophages) and bacterial spores. As different areas of application have different requirements, separate tests and pass criteria have been established for medical, veterinary and food, industrial, domestic & institutional sectors.
The microbial enumeration test, also called the bioburden test or the microbial load test, is performed to monitor the microbial content in raw materials, in-process samples, and finished product in the pharmaceutical, biological, cosmetics, nutritional products, and
medical device industry.
Sterility testing is required for medical devices that are labelled as sterile for manufacturers to prove that their production lots are free of contaminants and safe for use on people. There is a common misconception among manufacturers that sterility testing and test of sterility are the same. Here, we would like to explain the differences between the two so that our clients are aware what the two tests entail. Sterility testing is conducted to assess if a product or medical device is sterile after undergoing sterilisation process and the assessment is commonly conducted according to USP 71. Test of sterility on the other hand is used to evaluate the effectiveness of the sterilisation process used to sterilise medical devices and it is governed by ISO 11737-2:1998. Although one tests the product and the other the process, the method used to achieve both is the same, which is by testing the sterility of the end product. In a test of sterility however, 10 individual medical devices are tested and at least 9 of them must yield no growth of microbes in order to pass the test. Further investigation is
required if more than 2 devices yield growth.