particle counters Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/particle-counters/ Contamination control instruments and expertise Sun, 20 Aug 2023 16:24:09 +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 particle counters Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/particle-counters/ 32 32 BLOG: How Particle Counters Work https://www.pmeasuring.com/how-particle-counters-work-1/ Wed, 07 Jul 2021 15:30:33 +0000 https://www.pmeasuring.com/?p=102742 ...inside a cleanroom we could measure flakes of skin, small pieces of silicon or metal, or fungal spores... Most particles are non-uniform in structure, and this poses a question: How is the size qualified?

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]]> Viable and Non Viable Particle Counts https://www.pmeasuring.com/viable-non-viable-particle-counts/ Tue, 28 Apr 2020 06:22:09 +0000 https://www.pmeasuring.com/?p=65589 Environmental and Process Monitoring- Annex 1, Section 9.4 In Part 3 of our 5 part blog series, we look at Viable Non Viable (V/NV ) Particle counts regarding Environmental and Process Monitoring as found in Annex 1, Section 9.4: RA should be done to develop a comprehensive environmental monitoring program...

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]]> Contamination Control Strategy and Annex 1 https://www.pmeasuring.com/contamination-control-strategy/ Mon, 27 Apr 2020 15:26:08 +0000 https://www.pmeasuring.com/?p=66185 Science vs standardization: justification vs blindly following rules. The new auditors’ expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the...

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]]> Quality Risk Management in Annex 1; 6.1 https://www.pmeasuring.com/quality-risk-management-in-annex-1-6-1-3/ Wed, 29 Apr 2020 15:17:53 +0000 https://www.pmeasuring.com/blog/quality-risk-management-in-annex-1-6-1/ The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. In part 2 of our five-part series,...

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