TY - JOUR T1 - Parametric Release of Moist Heat Sterilized Products: History and Current State JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 527 LP - 536 DO - 10.5731/pdajpst.2022.012740 VL - 76 IS - 6 AU - Michael J. Sadowski AU - Stephen E. Langille Y1 - 2022/11/01 UR - http://journal.pda.org/content/76/6/527.abstract N2 - 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 severely limited in 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. This article examines the limitations and shortcomings of 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 of products terminally sterilized with moist heat is presented with a summary of the current status, including a listing of global regulatory standards and guidances along with a 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. ER -