contamination control Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/contamination-control-da/ Contamination control instruments and expertise Fri, 07 Feb 2025 15:04:50 +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 contamination control Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/contamination-control-da/ 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...

The post Data Analytics in Pharmaceutical Manufacturing appeared first on Particle Measuring Systems.

]]> Considerations and Steps for Building a Contamination Control Strategy – Series Part 4 of 4 https://www.pmeasuring.com/building-a-contamination-control-strategy-series-part-four/ Mon, 28 Jun 2021 21:28:20 +0000 https://www.pmeasuring.com/?p=104911 Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.

The post Considerations and Steps for Building a Contamination Control Strategy – Series Part 4 of 4 appeared first on Particle Measuring Systems.

]]> Filter Contamination Testing with the Chem 20 Particle Counter https://www.pmeasuring.com/filter-performance-check-chem-20/ Wed, 24 Mar 2021 15:00:34 +0000 https://www.pmeasuring.com/?p=92154 The Chem 20 was placed inline with a dedicated filter-wetting machine used by a semiconductor manufacturer to study the effect of wetting and flushing new particle filters before they are used in production.

The post Filter Contamination Testing with the Chem 20 Particle Counter appeared first on Particle Measuring Systems.

]]> Controlling Particle Contamination in Chemical Distribution https://www.pmeasuring.com/chemical-particle-contamination-distribution-module/ Wed, 17 Mar 2021 15:00:54 +0000 https://www.pmeasuring.com/?p=92109 Chemical distribution modules control the supply of ultrapure process chemicals to the point of use. The chemical shouldn't contain yield-threatening particle contamination here due to contact with wafers, masks, and other critical surfaces.

The post Controlling Particle Contamination in Chemical Distribution appeared first on Particle Measuring Systems.

]]> 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.

The post How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) appeared first on Particle Measuring Systems.

]]> Cleanroom Process Risk Assessment per Annex 1 https://www.pmeasuring.com/cleanroom-process-risk-assessment-annex-1/ Fri, 01 May 2020 06:45:39 +0000 https://www.pmeasuring.com/?p=65617 In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Cleanroom Process Risk Assessment: Why it’s important A process risk assessment helps you...

The post Cleanroom Process Risk Assessment per Annex 1 appeared first on Particle Measuring Systems.

]]> Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6) https://www.pmeasuring.com/how-to-achieve-quality-by-design-qbd-in-a-new-pharmaceutical-fill-line-environmental-monitoring-series-part-5-of-6/ Wed, 29 Apr 2020 07:22:51 +0000 https://www.pmeasuring.com/?p=64053 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.

The post Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6) appeared first on Particle Measuring Systems.

]]> Quality Risk Management Principles in Annex 1, Section 2 https://www.pmeasuring.com/quality-risk-management-principles-in-annex-1-section-2/ Wed, 29 Apr 2020 15:12:49 +0000 https://www.pmeasuring.com/blog/quality-risk-management-principles-in-annex-1-section-2/ 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. Here we highlight requirements related to Quality...

The post Quality Risk Management Principles in Annex 1, Section 2 appeared first on Particle Measuring Systems.

]]>