PDA技术报告第30号（2012年修订）:湿热灭菌药物的参数释放提供了这种无菌产品释放方法的当前最佳实践，重点是在开发湿热灭菌药物和医疗器械产品的参数释放程序期间使用基于科学的方法。最初的报告是开创性的，因为它支持对无菌检测问题的合理解决方案。该文件最初发表于1999年，概述了一个无菌保证发布计划，该计划建立在对经验证的无菌产品制造过程进行有效控制、监控和记录的基础上，其中无菌释放取决于关键操作参数的证明实现，而非最终产品无菌测试。 在该计划中，关键操作参数和性能属性是针对灭菌过程之前和期间发生的工艺步骤确定的。自1999年以来，全球许多监管机构和药典组织已经认可了参数释放的使用，并通过制定支持标准、指南和推荐做法促进了其实施。由于越来越多地采用参数化发布，因此有必要对1999年的报告进行更新。参与修订TR的工作组- 30名专家由来自全球各地的行业科学家、微生物学家和工程师组成，以确保在湿热灭菌药品和医疗设备的参数释放方面提供科学合理的最佳实践。

PDA Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release program for pharmaceutical and medical device products terminally sterilized by moist heat. The original report was groundbreaking in that it espoused a rational solution to the problem of the sterility test. Published originally in 1999, the document outlined a sterility assurance release program that is founded upon effective control, monitoring, and documentation of a validated sterile product manufacturing process where sterility release is dependent upon demonstrated achievement of critical operational parameters in lieu of end product sterility testing. In this program, critical operational parameters and performance attributes are determined for process steps that occur prior to and during the performance of the sterilization process. Since 1999, many regulatory agencies and pharmacopoeial organizations across the globe have recognized the use parametric release and have fostered its implementation through the development of supporting standards, guidances and recommended practices. This growing adoption of parametric release necessitated an update to the 1999 report. The task force that participated in revising TR-30 was comprised of industry scientists, microbiologists and engineers from regions across the globe to ensure scientifically sound best practices were presented regarding parametric release of moist heat sterilized pharmaceutical products and medical devices.