USP30-1211翻译-灭菌和无菌保证.docVIP

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 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71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 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 sterility 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 likelihood 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 on sterility testing. The basic principles for validation and certification of a sterilizing process are enumerated as follows: 许多无菌状态据说是消过毒的,因此是或然论的定义污染的个体和物品可能性是在可以接受的细小范围的.这样一个无菌状态保证,仅能通过适当的灭菌周期和无菌的后续加工,即便要,在当前合适的GMP程序下,无菌测试也不可靠.一个无菌过程验证的基本原理如下: Establish that the process equipment has capability of operating within the required parameters. 确定加工设备的操作性能处在正确的参数. Demonstrate that the critical control equipment and instrumentation are capable of operating within the prescribed parame