Parametric release can be defined as a sterility assurance release program where demonstrated control of the sterilization process enables a company to use defined critical process controls, in lieu of the sterility test.
For a product released using the Sterility Tests, once the device is terminally sterilized, there is an incubation period of several days to allow for possible microbial growth in samples before obtaining results from this test. During this waiting period, the device is placed on hold (not released for sale), potentially occupying valuable space, but more importantly delaying patient access to critical devices.
For a device released using parametric release, once the device is terminally sterilized and the acceptance criteria for the critical process parameters are documented as being met, the product can be released for commercial sale, provided that all other release test criteria have been met. In Esterilizacion,s.l. we are adapting our facilities, as well as our control software to comply with the technical specifications of parametric release, being able to offer shortly all our customers this other way to release their products.