USP301211翻译灭菌和无菌保证Word格式.docx

1、1211 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES灭菌和无菌保证纲要条款This informational chapter provides a general description of the concepts and principles involved in the quality control of articles that must be sterile. Any modifications of or variations in sterility test procedures from

2、those described under Sterility Tests 71 should be validated in the context of the entire sterility assurance program and are not intended to be methods alternative to those described in that chapter.报告章节规定涉及到条款质量控制总的概念描述和原则是必须是无菌的.从无菌测试的章节描述中,无菌保证程序的整个上下文中规定没有可选择的方法,任何有关无菌测试程序变更或修改应该得到验证.Within the

3、 strictest definition of sterility, a specimen would be deemed sterile only when there is complete absence of viable microorganisms from it. However, this absolute definition cannot currently be applied to an entire lot of finished compendial articles because of limitations in testing. Absolute ster

4、ility cannot be practically demonstrated without complete destruction of every finished article. 在最严格的无菌定义里,仅当它不含有任何可存的微生物,样品才被认为无菌.然而, 因为测试的局限性，这个绝对的定义不能普遍应用到整个纲要条款中。实际上每个灭菌的物品没有完全的破坏，绝对无菌性不能得到论证。The sterility of a lot purported to be sterile is therefore defined in probabilistic terms, where the l

5、ikelihood of a contaminated unit or article is acceptably remote. Such a state of sterility assurance can be established only through the use of adequate sterilization cycles and subsequent aseptic processing, if any, under appropriate current good manufacturing practice, and not by reliance solely

6、on sterility testing. The principles and implementation of a program to validate an aseptic processing procedure are similar to the validation of a sterilization process. In aseptic processing, the components of the final dosage form are sterilized separately and the finished article is assembled in

7、 an aseptic manner. 验证一个无菌处理程序的法则和执行和灭菌过程的确认是相似的.在无菌处理中,最终剂量组成成分是分别灭菌的,最后物品的组装是在无菌方式完成的.Proper validation of the sterilization process or the aseptic process requires a high level of knowledge of the field of sterilization and clean room technology. In order to comply with currently acceptable and a

8、chievable limits in sterilization parameters, it is necessary to employ appropriate instrumentation and equipment to control the critical parameters such as temperature and time, humidity, and sterilizing gas concentration, or absorbed radiation.灭菌过程或无菌程序正确确认要求较高的灭菌和绝对无尘室技术领域的知识水平. An important aspe

9、ct of the validation program in many sterilization procedures involves the employment of biological indicators （see Biological Indicators 1035 ）.在许多灭菌程序一个重要的确认纲要方面包括生物指示剂的使用（参见生物指示剂-）.The validated and certified process should be revalidated periodically; however, the revalidation program need not n

10、ecessarily be as extensive as the original program.验证和鉴定的程序应当定时性地重新生效,然而,重新生效程序不必像原始文件那样广泛.A typical validation program, as outlined below, is one designed for the steam autoclave, but the principles are applicable to the other sterilization procedures discussed in this informational chapter. The pr

11、ogram comprises several stages.一个典型的确认程序如下列大纲,一个蒸汽高压灭菌锅设计而作,但原理也是适用于其它的灭菌程序,将在报告章节讨论.The installation qualification stage is intended to establish that controls and other instrumentation are properly designed and calibrated. Documentation should be on file demonstrating the quality of the required u

12、tilities such as steam, water, and air.限定时期安装目的建立调节装置和其它的使用仪器能够得到适当设计和校准.文件能够记录下来备查证明要求效用的质量像蒸汽,水,空气.The operational qualification stage is intended to confirm that the empty chamber functions within the parameters of temperature at all of the key chamber locations prescribed in the protocol.可操作资格的时

13、期是打算确认在协议规定的所有关键锅室区域在温度参数以内的锅室功能.It is usually appropriate to develop heat profile records, i.e., simultaneous temperatures in the chamber employing multiple temperature-sensing devices.它通常适用于显示压力剖面的记录也就是在锅室使用多种温度敏感装置 A typical acceptable range of temperature in the empty chamber is 1 when the chamb

14、er temperature is not less than 121. 当锅室温度不少于121,一个典型的可接受的锅室温度幅度范围是1.The confirmatory stage of the validation program is the actual sterilization of materials or articles. 确认程序的确认时期是原料或物品实际灭菌期.This determination requires the employment of temperature-sensing devices inserted into samples of the arti

15、cles, as well as either samples of the articles to which appropriate concentrations of suitable test microorganisms have been added, or separate BIs in operationally fully loaded autoclave configurations. 决定要求温度敏感装置嵌入到物品样本中,除了添加微生物测试需要的适当的物品浓度,或在操作上二度单独的装满物品的高压灭菌锅装置. The effectiveness of heat delive

16、ry or penetration into the actual articles and the time of the exposure are the two main factors that determine the lethality of the sterilization process. The final stage of the validation program requires the documentation of the supporting data developed in executing the program.热传递或穿透实际物品的效力和曝光时间是两个主要的因素决定灭菌程序的破坏性.确认的最终阶段需要执行程序的数据支持文件发展更新.It is generally accepted that terminally sterilized injectable articles or