iso 14644 Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/iso-14644-en-ch-sg/ Contamination control instruments and expertise Sun, 20 Aug 2023 14:19:15 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://www.pmeasuring.com/wp-content/uploads/2018/12/cropped-pms-icon-1-150x150.png iso 14644 Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/iso-14644-en-ch-sg/ 32 32 Cleanroom Monitoring System per Annex 1 draft https://www.pmeasuring.com/cleanroom-monitoring-annex-1/ Tue, 19 May 2020 05:49:20 +0000 https://www.pmeasuring.com/?p=65782 Cleanroom Monitoring v. Classification v. Cleanroom Qualification Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of a cleanroom monitoring system is to assess the potential contamination risk of the product. The...

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]]> Cleanroom Classification https://www.pmeasuring.com/cleanroom-classification/ Fri, 08 May 2020 06:08:25 +0000 https://www.pmeasuring.com/?p=65646 Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest EU GMP Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which is...

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