cleanroom control Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/cleanroom-control-da/ 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 control Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/cleanroom-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...

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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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]]> 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...

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]]> Cleanroom Contamination Control in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6) https://www.pmeasuring.com/cleanroom-contamination-fill-line-cleaning-disinfection/ Wed, 15 Apr 2020 08:54:09 +0000 https://www.pmeasuring.com/?p=63978 Cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of cleanroom contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this form of control wrong without applying the standards of QbD to...

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