中英文-pda-tr03-干热灭菌验证.pdf

???????????????????????????????????????????????????????????????????????????????????????????????????????????????? ?????????????????????????????????????1 1.0 Introduction 简介简介 This technical report is an update of PDA's Technical Report No. 3, Validation of Dry Heat Processes used for Sterilization and Depyrogenation which was issued in 1981. The technical report focuses on the microbiology and engineering qualification of dry-heat sterilization and depyrogenation processes and the general approach to sterilization and depyrogenation science in batch and continuous sterilizers (ovens and tunnels). This technical report is based on standard depyrogenation and sterilization science. 这份技术报告是1981年发布的PDA第3号技术报告“用于灭菌和除热原的干热灭菌工艺验证”的更新。

这份技术报告着重于干热灭菌和除热原工艺的微生物和设计确认，以及批次生产和连续性灭菌器（烘箱和隧道）中灭菌和除热原的通用方法这份报告的依据是标准除热原和灭菌科学 The primary objective of the Technical Report Team was to develop a scientific technical report on dry-heat depyrogenation and sterilization processes that provides recommendations for use by industry and regulators. References to appropriate and current scientific publications, international regulatory documents, journal articles, technical papers and books are used where more detail and supportive data can be found. 技术报告团队的主要目的是开发有关干热除热原和灭菌工艺的科学技术报告，能够对用于工业生产和法规提供建议。

采用了适宜并是当前的科学出版物、国际法规文件、期刊论文、技术报告以及书籍这些参考资料，其中有更详细和更具支持性的数据 The Technical Report Team is composed of diverse international team of professionals to ensure the methods, terminology and practices of dry-heat depyrogenation and sterilization processes reflect sound science and can be used globally. This technical report was disseminated in draft for public review and comment prior to publication to ensure its suitability as a recommendation of best practices to industry. 技术报告团队由不同的国际团队专家组成以保证干热除热原和灭菌工艺的方法，术语以及实践能够反映全面的科学性并能够全球通用。

这份技术报告在正式发表前以公众评论的形式传播，以保证其作为工业中最佳实践建议的合理性 1.1 Purpose and Scope 目的和范围目的和范围 This technical report provides information to the manufacturers of pharmaceutical products for validating dry-heat depyrogenation and sterilization processes. The concepts and methods presented within this technical report are not intended to be a regulatory standard, but rather as points to be considered during the validation of dry-heat processes. Other technically equivalent methods may exist and may be used if they can be supported by sound scientific methods. 这份技术报告提供了关于制药生产企业进行干热除热原和灭菌工艺验证的相关信息。

该技术报告中提到的概念和方法不是一项法规标准，但是可作为干热工艺验证中的指导其他等效的技2 术方法也可能存在并被应用，如果这些其他方法有合理的科学方法做支持 This technical report is intended to give information about current industry practices and approaches to validating dry-heat depyrogenation and sterilization processes. In addition, sections will cover various aspects of dry-heat sterilization using biological indicators. 这份技术报告的目的是为目前工业实践以及干热除热原和灭菌工艺验证方法提供信息支持此外，报告的一些章节覆盖了干热灭菌使用的生物指示剂的各方面 This technical report is organized in a chronological fashion, starting with a discussion of the general concepts of depyrogenation and sterilization science which are the foundation upon which to build a robust process. This includes use of biological indicators and endotoxin indicators. Also included are points to consider in equipment design, equipment verification, process development and performance qualification for new systems and the development and validation of processes for existing systems. 该技术报告是以时间顺序排列，以除热原和灭菌科学的通用概念开始，而这是建立稳固工艺的基础。

其中包括了生物指示剂和内毒素指示剂的使用也包括了新系统的设备设计、设备确证、工艺开发以及性能确认，还包括现有系统中工艺设计和验证中所需考虑的问题 In the discussion of process development, particular attention has been given to the load type, loading patterns, and temperature profiles for depyrogenation and sterilization in both ovens and tunnels. The sections are followed by a brief discussion of items for consideration during routine processing and ongoing maintenance of the validated process. 工艺开发的讨论中，对于在烘箱和隧道中进行除热原和灭菌的负载种类、负载模式以及温度曲线都给予特殊的关注在已验证工艺的日常操作和持续维护中所需考虑的内容在这一部分也做了简要讨论。

The background sections on depyrogenation/sterilization science and endotoxin/biological indicators are not comprehensive—but provide information specific to dry-heat processes. Information within the technical report is applicable to both forced hot air dry-heat batch processes (chambers) and to continuous processes (tunnels). Information within this technical report does not apply to dry-heat processes used for the sterilization of oil bases and oil based products, fixed processing streams or to those processes using infrared and microwave heating media. 关于除热原/灭菌科学和内毒素/生物指示剂的背景部分并不全面——但是所提供的信息是针对干热工艺的。

技术报告中的信息既适用于强制热空气干热批生产工艺（腔体），也适用于连续性工艺（隧道）本技术报告中的信息不适用于油性基质及油性基质产品，固定工艺流程或者那些使用红外及微波加热介质的工艺中灭菌所用的干热工艺 Current FDA, ICH, and other regulatory definitions are used except when more clarity is added by the Technical Report Team. Regulatory guidelines offer other definitions that maybe considered. Variations in the use of some terms may differ from company to company and 3 some may be subject to change in the f。