ABSTRACT
Parametric release streamlines the ethylene oxide sterilization process. Increased operational efficiency is realised through accelerated turnaround time for sterilization resulting from the elimination of several manufacturing steps, consumable and laboratory services, as well as reduction in the chance for human error. Parametric release is the release of medical devices from poststerilization quarantine based on a review of the physical cycle data demonstrating conformance to validated process specifications. Implementation of parametric release raises considerable technical questions, regarding upgrades that the user must carefully evaluate in order to validate and maintain a release method effectively. These required changes impact the following areas: staff knowledge, customer communication, equipment performance and control, gas analysis requirements, process validation and routine process control. Economic pressures exerted on the entire medical device supply chain have forced each segment of the industry to seek ways of delivering product to the market faster and more economically.
