Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
Powder Filling: The Monitoring Process and its Background in Regulation
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
High Flowrate Monitoring Uses and Benefits
Sampling standards keep managers of environmental monitoring (EM) on their toes. Read this blog to learn more about how to use high flowrate monitoring to make the most out of your EM practices in less time.
Cleanroom Process Risk Assessment per Annex 1
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. Process Risk Assessment: Why it’s important A process risk assessment helps you to to ensure risks are properly […]
Potential Cleanroom Sampling Points per Annex 1 Draft
In part 4 of our part 5 blog series on Annex 1 Quality Risk Management, we discuss cleanroom sampling points. Definition of potential sampling points 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 […]
Viable Non Viable Particle Counts
Viable, non viable particle counts: 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 […]
Quality Risk Management (QRM), Annex 1, Section 2
In Annex 1 Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations. 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 Risk Management that are specifically mentioned in Annex 1, including: […]
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, we highlight requirements related […]
Compressed Gas Contamination Monitoring in Pharma and Cosmetics Manufacturing: Monitoring Program (Series Part 2 of 2)
The regulatory requirements and best practices for monitoring compressed gasses in the Pharmaceutical and Cosmetics & Personal Care industries are explored.
Compressed Gas Contamination Monitoring in Pharma and Cosmetics Manufacturing: Standards (Series Part 1 of 2)
The regulatory requirements and best practices for monitoring compressed gasses in the Pharmaceutical and Cosmetics & Personal Care industries are explored.
