filling line Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/filling-line-da/ Contamination control instruments and expertise Mon, 06 Nov 2023 16:40:55 +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 filling line Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/filling-line-da/ 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...

The post Cleanroom Monitoring System per Annex 1 draft appeared first on Particle Measuring Systems.

]]> Potential Cleanroom Sampling Points per Annex 1 Draft https://www.pmeasuring.com/cleanroom-sampling-points-annex-1/ Thu, 30 Apr 2020 06:33:28 +0000 https://www.pmeasuring.com/?p=65594 EU GMP Annex 1 provides guidance on choosing effective cleanroom sampling points. Definition: Cleanroom Sample points include particle counters and microbial monitors. Identification of critical areas by HACCP analysis and process understanding Choose points within the critical areas according to defined criteria When performed this way, you can demonstrate a...

The post Potential Cleanroom Sampling Points per Annex 1 Draft 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.

]]> 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...

The post Cleanroom Contamination Control in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6) appeared first on Particle Measuring Systems.

]]>