PDATR13环境监控.docVIP

[翻译] PDA TR13 环境监控 2015-09-21?北京齐力佳  文章来源：北京齐力佳整理 1.0 INTRODUCTION简介 The purpose of this document is to identifymicrobiological and particulate control concepts and principles as they relateto the manufacture of sterile pharmaceutical products. It expandssubstantially upon the first edition of Technical Report No. 13, Fundamentalsof a Microbiological Environmental Monitoring Program, published by PDA in1990. While this publication cannot possibly supplant the wealth ofinformation published on this subject, it provides summary information andappropriate references for the reader to consult, if necessary. The objectivewas to contemporize the first edition through the utilization of current definitions,recognition of improved environmental monitoring procedures, and equipment. 本文件目的是确定微生物和微粒控制的概念和原则，因为这涉及到无菌药品的生产。文件全称为第13号技术报告第一版，微生物的环境监测计划基础，PDA于1990年出版。尽管本出版物不可能取代题目的信息价值，它提供了读者查阅必要的主要信息及相关参考。其目的是通过使用当前定义，改善后的环境监测程序和设备来与第一版同步。 This document should be considered asguidance; it is not intended to establish any mandatory or implied standard.此文件应作为指南；而不是建立任何强制或隐含的标准。 The task force consisted of membersrepresenting global companies, to ensure that the methods, terminology, andpractices reflect the procedures utilized globally. Technical reviews wereperformed by some of the more prominent environmental monitoring scientists inthe world today. 工作团队由代表全球性公司的成员组成，以确保方法，术语和规程反映了全球范围内使用的程序。技术审查由一些全球重要的环境监测科学家进行。 This document serves as a source on cleanroom environmental test methods, and although some non-viable particulate andendotoxin testing data are included, its primary focus is microbiologicalcontrol. The concepts for sterile product manufacturing are the most stringentapplication, but these concepts can also be applied to non-sterile productmanufacture. The focus is environmental monitoring as it relates to facilitycontrol and compliance. This document was compiled to aid in setting up aprogram that is meaningful, manageable, and defendable. 这份文件作为洁净室环境测试方法的来源，虽然包括一