Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.
The CCS is designed to ensure quality risk management is built into every pharmaceutical process from the ground up, and every quality decision made has a foundation in scientific reasoning.
How Particle Measuring Systems Support Pharmaceutical Cleanroom Monitoring After deciding on a cleanroom Facility Monitoring System (FMS) it is time to implement it. Many things can go wrong. You want an implementation that does not negatively impact production, that is smooth and successful, and is ready to hand off on schedule. Eric Gottlieb talks to Blu Buquoy about […]
In this blog series, we’ll be looking at the signal pathway for a typical liquid particle counter and two case studies with the Ultra DI liquid particle counters to understand how the detection of the smallest contamination was revolutionized and recharged for counting on the nano-scale.
When particle counters work together to give data on the state of contamination control, they’re going to disagree on the numbers. But why do the counts not match? The answer encompasses model, manufacturing, engineering design, and calibration.
Remote working, and allowing fewer vendors onsite can make projects very challenging, sometimes pausing projects indefinitely. David Quelle, GM of PMS Brazil, discusses one example where the Particle Measuring Systems’ team was able to work with a customer to remotely validate their FaciltyPro Environmental monitoring system & MiniCapt Monitors and conduct training.
Interview with Frank Panofen, Life Science Marketing Manager at Particle Measuring Systems How do we solve cleanroom contamination control issues when face to face discussions and in-person visits are not an option? In this interview, Dr. Frank Panofen of Particle Measuring Systems (PMS) explains how PMS advisors tackled travel restrictions and the inability to visit […]
The 2020 release of the EU GMP Annex 1 includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity that is referenced multiple times. We discuss the changes here.
When Argonaut Manufacturing was setting up their new state-of-the-art fill line they wanted the best contamination monitoring solution in a tight timeframe. Watch how Argonaut and PMS worked together to complete the mission.
The HandiLaz® Mini II handheld particle counter offers a powerful and nimble solution for pre-certification steps, identifying potential contamination hotspots, and troubleshooting high particle areas.