ABSTRACT
Contract laboratories, like contract sterilizers, are an extension of the manufacturer's operation. As such, the contract test lab must comply with the Food and Drug Administration QSR rule. Environmental control in areas where terminally sterilized devices are manufactured is a key component in ensuring low levels of product bioburden. The effects of sterilization on device materials and potential leachables, as well as toxic by-products as a consequence of sterilization should be considered. Historically, vials or glass components have been rendered pyrogen-free by dry heat sterilization at high temperatures. The technician performing the testing should document all activity occurring in the room, including number of operators, equipment in use, overall activity, amount of packaging material, and location of sampling points. In the medical device industry, LAL testing is performed as a batch release test on products that come into contact with blood or cerebrospinal fluid.
