Tag: contamination control

NewsContinuous Monitoring Concept

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 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.

NewsCleanroom Design particle loss in tubing

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. Cleanroom Process Risk Assessment: Why it’s important A process risk assessment helps you…

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.

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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