• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Biocontrol Science >Validation Study and Routine Control Monitoring of Moist Heat Sterilization Procedures
【24h】

Validation Study and Routine Control Monitoring of Moist Heat Sterilization Procedures

机译：湿热灭菌程序的验证研究和例行控制监控

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The proposed approach to validation of steam sterilization in autoclaves follows the basic life cycle concepts applicable to all validation programs. Understand the function of sterilization process, develop and understand the cycles to carry out the process, and define a suitable test or series of tests to confirm that the function of the process is suitably ensured by the structure provided. Sterilization of product and components and parts that come in direct contact with sterilized product is the most critical of pharmaceutical processes. Consequently, this process requires a most rigorous and detailed approach to validation. An understanding of the process requires a basic understanding of microbial death, the parameters that facilitate that death, the accepted definition of sterility, and the relationship between the definition and sterilization parameters. Autoclaves and support systems need to be designed, installed, and qualified in a manner that ensures their continued reliability. Lastly, the test program must be complete and definitive. In this paper, in addition to validation study, documentation of IQ, OQ and PQ concretely were described.
机译：提出的验证高压灭菌器中蒸汽灭菌的方法遵循适用于所有验证程序的基本生命周期概念。了解灭菌过程的功能，发展和理解执行该过程的周期，并定义适当的测试或一系列测试，以确认所提供的结构适当地确保了过程的功能。与灭菌产品直接接触的产品及零部件的灭菌是制药过程中最关键的部分。因此，此过程需要最严格和详细的验证方法。对过程的理解需要对微生物死亡，对导致死亡的参数，无菌的可接受定义以及定义与灭菌参数之间的关系有基本的了解。高压釜和支撑系统需要以确保其持续可靠性的方式进行设计，安装和鉴定。最后，测试程序必须完整且确定。在本文中，除了验证研究之外，还具体描述了IQ，OQ和PQ的文档。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号