cleanroom monitoring Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/cleanroom-monitoring-da-sg/ Contamination control instruments and expertise Fri, 28 Jun 2024 19:39:09 +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 cleanroom monitoring Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/cleanroom-monitoring-da-sg/ 32 32 Data Analytics in Pharmaceutical Manufacturing https://www.pmeasuring.com/pharmaceutical-manufacturing-data-management-environmental-monitoring/ Mon, 29 Jan 2024 18:22:39 +0000 https://www.pmeasuring.com/?p=138134 What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without...

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]]> Cleanroom Qualification https://www.pmeasuring.com/cleanroom-qualification/ Tue, 12 May 2020 06:18:29 +0000 https://www.pmeasuring.com/?p=65715 Cleanroom Qualification – Classification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies are identified in EU...

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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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]]> How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) https://www.pmeasuring.com/how-to-achieve-quality-by-design-qbd-in-a-new-pharmaceutical-fill-line-activity-organization-series-part-6-of-6/ Sun, 03 May 2020 20:41:49 +0000 https://www.pmeasuring.com/?p=64052 In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

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