Baxter Healthcare, Round Lake, IL 60073; and
ValSource, Inc., Downingtown, PA 19335.
PDA J Pharm Sci Technol. 2022 Nov-Dec;76(6):527-536. doi: 10.5731/pdajpst.2022.012740. Epub 2022 Jul 15.
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.
无菌检测多年来一直被用于通过湿热和其他灭菌方式对最终灭菌产品放行提供正式的无菌支持。众所周知，无菌检测在为成品的无菌性提供有意义的科学和统计依据方面受到严重限制。因此，参数放行作为一种无菌保证放行方案得到了发展，该方案定义了无菌放行所必需的关键生产工艺和灭菌控制参数，从而消除了无菌检测的使用。本文探讨了无菌检测的局限性和不足，并通过案例研究的结果说明了过度依赖该检测方法处理无菌产品的风险。本文介绍了湿热灭菌产品的参数放行历史，总结了当前的状况，包括全球监管标准和指南的列表，以及湿热灭菌实践行业调查的相关结果讨论。本文旨在为建立对参数放行概念和实践的基本理解奠定基础，这些概念和实践可以作为未来推广和扩大实施的基准。
