Biological indicators, tools to verify the effect of sterilisation processes - position paper prepared on behalf of group 1 (biological methods and statistical analysis).

Q4 Medicine
Pharmeuropa bio & scientific notes Pub Date : 2011-11-01
K Haberer, H van Doorne
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引用次数: 0

Abstract

Biological indicators (BIs) are test systems containing viable microorganisms (usually spores of bacteria) providing a defined challenge to a specified sterilisation process. General chapter 5.1.2 of the European Pharmacopoeia [1] (Ph. Eur.) sets specifications for BIs and gives some guidance for their use. As shown in this text, the approach followed by Ph. Eur. as well as by ISO standards is outdated and could create nowadays some confusion among the users of the pharmacopoeia. It is the objective of this paper to provide the theoretical background of BIs as tools for the design and qualification of reliable moist heat sterilisation processes. The principles laid down in this article will form the basis of a future draft on a revised chapter on BIs in Pharmeuropa.

生物指标,验证灭菌过程效果的工具-代表第1组(生物方法和统计分析)准备的意见书。
生物指示剂(BIs)是含有活菌(通常是细菌孢子)的测试系统,对特定的灭菌过程提供确定的挑战。欧洲药典通论5.1.2章[1](Ph. Eur.)规定了BIs的规格并给出了一些使用指南。如本文所示,Eur博士所采用的方法。以及ISO标准已经过时,并且可能在药典用户中造成一些混乱。本文的目的是提供BIs作为设计和确定可靠的湿热灭菌工艺的工具的理论背景。本条规定的原则将构成今后关于《Pharmeuropa》中关于BIs的修订章节草案的基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
CiteScore
0.70
自引率
0.00%
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