Cleanroom monitoring system qualification made easy

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作者：
Solmaz, Haslm
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来源：
Cleanroom Technology | 2019年 / 27卷 / 11期
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摘要：
A step-by-step guide to the required activities leading to the qualification of a cleanroom monitoring system as per the right-hand side of GAMP 5 V Scheme. In conversations leading up to establishing an online particle monitoring systems, most cleanroom users mention the following request for their User Requirement Specification (URS) document: IQ, OQ and PQ will be provided by the supplier. The acronyms stand for installation, operation and performance qualification, respectively.
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