PDA TR27（中英文）-1998 包装完整性.pdf

Pharmaceutical Package Integrity 药物包装完整性 Technical Report No.27 27 技术报告第 号 PDA April 1998 1998 4 年 月 1. Preface 前言 This report reviews issues of pharmaceutical product package integrity and provides guidance for evaluating the barrier qualities of a pharmaceutical package. It supersedes the previously issued PDA Technical Information Bulletin No. 4,Aspects of Container/Closure Integrity. Inthis updated guideline,the term product package is used, rather than the term container/closure system, as it encompasses any nonporous barriersystemthat protects a pharmaceutical productfromthe environment. Similarly, the term package seal is used generically to mean all types of seals or closure systems.Although it is written to reflect the complexity of all pharmaceutical products and packages, the emphasis throughout the document is clearly on packaging intendedforsterile products. 该报告审核了药物产品包装完整性的主题，为评价药物包装的屏障质量的评价提供了指 PDA 4 / 南。它代替了先前发布的 “ 技术信息通告第 号：包装容器密封完整性方面”。在 该升级的指南中，使用术语 “产品包装”，而不是术语 “包装容器密封系统”，因为它包/ 含了任何用于保护药物产品隔绝于环境的无孔屏障系统。同样，一般也使用术语 “包装 密封”，意味着所有类型的密封或密闭系统。虽然，书面上是反映所有药物产品和包装的 复杂性，整个文件强调的重点明显是意图用于无菌产品的包装。 This report was written by the following members of the PDA Task Force on Container/Closure Integrity: 该报告由PDA 关于容器密封完整性的特别工作组的下列成员撰写：/ Michael C.Carroll,The Liposome Company, Inc. Vivian F.Denny, Peakto Peak PharmaceuticalAssociates Dana M.Guazzo, Ph.D.,The R.W.Johnson Pharmaceutical Research Institute MarkW.Kaiser,Lancaster Laboratories Lee E. Kirsch, Ph.D.,The University of Iowa John D. Ludwig, Ph.D.,G. D.Searle and Company Gerald K. Masover,Genentech, Inc. Jeri L. May,DuPont Merck Pharmaceutical Co. Jeanne E. Moldenhauer, Ph.D., Fujisawa USA, Inc. Jean I.Olsen,SmithKline Beecham Pharmaceuticals Terri M. Poison,Glaxo Wellcome Inc. Glenn E.Wright, Eli Lilly Co. In addition,theTask Force acknowledges the immense help and