Sterility Testing and Developing or Validating Product-Specific Methods Are Critical Steps in Drug Development

Prominent players in the pharmaceutical Sterility Testing sector, as well as a number of smaller companies providing specialised services or goods. These include companies that specialise in testing specific types of products, such as biologics or gene therapies. There are also companies that focus on specific testing methods and technologies.

Sterility Testing is required to ensure that viable contaminating micro-organisms are not detectable in a product. This testing is carried out by direct inoculation or membrane filtration methods and can be carried out in an isolator or clean room environment.

A bacteriostasis/fungistasis test is conducted in conjunction with the sterility test to determine whether the test item inhibits the growth of microorganisms. The B/F test is necessary to verify the sterility result and to ensure that the device does not have any antibacterial capabilities that would prevent the detection of microorganisms during the sterility test.

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