Parametric Release of Moist Heat Sterilized Products: History and Current State

Abstract

The sterility test has been utilized for many years to formally support the sterile release of products terminally sterilized by moist heat and other sterilization modalities. It is well-known that the sterility test is wholly incapable of providing a meaningful scientific and statistical basis to support the sterility of finished products. Accordingly, Parametric Release was developed as a sterility assurance release program that defines critical manufacturing process and sterilization control parameters that are essential for sterile product release thereby eliminating the use of the sterility test. The article examines the limitations and shortcomings for the sterility test and reviews the findings from a case study to illustrate the risks associated with the overreliance on this test for the disposition of sterile products. The history of Parametric Release is presented with summary of current status including a listing of global regulatory standards and guidances along with discussion of applicable results from an industry survey of moist heat sterilization practice. This article is intended to be the initial step to establish a basic understanding of the Parametric Release concept and practices that can be leveraged as a baseline for future promotion and expanded implementation.