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Implementation of a cleaning validation program in a multi-product manufacturing facility.

机译：在多产品制造工厂中实施清洁验证程序。

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摘要

The general objective of cleaning and sanitizing of pharmaceutical manufacturing facilities is to ensure that the products manufactured and cleaning agents used do not leave residues behind that will adulterate the quality of the finished product. Cleaning validation is the documented proof that a particular pharmaceutical facility can consistently and effectively clean a system or equipment item. Every pharmaceutical organization is mandated to put in place a validated cleaning program. It is required by the regulations of GMP (Good Manufacturing Practice) and enforced by the U.S. Food and Drug Administration. It is the intent of this document to increase the awareness of the cleaning validation concept to all levels of employees so as to facilitate the execution of such a major undertaking. This thesis will describe and examine the various key elements of a cleaning validation program by focusing on the fundamentals and strategies of cleaning and presenting a series of mathematical calculations on how to derive cleaning limits.
机译：药品生产设施的清洁和消毒的总体目标是确保所生产的产品和使用的清洁剂不会留下残留物，这些残留物会污染最终产品的质量。清洁验证是有记录的证明，证明特定的制药设施可以始终有效地清洁系统或设备项目。每个药品组织都必须执行经过验证的清洁程序。它是GMP（良好生产规范）的规定所要求的，并由美国食品药品监督管理局执行。本文档旨在向所有级别的员工提高对清洁验证概念的认识，以便于执行这项重要任务。本文将着重于清洁的基本原理和策略，并就如何得出清洁极限提出一系列数学计算方法，以描述和检验清洁验证程序的各个关键要素。

著录项

  • 作者

    Hsu, Hussein.;

  • 作者单位

    California State University, Dominguez Hills.;

  • 授予单位 California State University, Dominguez Hills.;
  • 学科 Engineering Chemical.;Engineering Industrial.
  • 学位 M.S.
  • 年度 2000
  • 页码 68 p.
  • 总页数 68
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 现代史（1917年~）;
  • 关键词

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