Category: Facility Monitoring

NewsQuality by Design QbD

Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6)

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 Systemsā€™ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

NewsISO EN 17141 smoke study

Viable and 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…

NewsCondensation Particle Counters

Contamination Control Strategy and Annex 1

Science vs standardization: justification vs blindly following rules. The new auditorsā€™ expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the…

NewsAirflow Visualization best particle counter ISO cleanroom standards

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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