The transition to a continuous monitoring system now continuously demonstrates adherence to control parameters (which you use to define alert and action levels), and only instances…
Catching Up with GMP Requirements
…current good manufacturing practices (GMPs) and how they can be applied to a continuous monitoring system installed within a facility. Quality and Production teams can then establish new monitoring understandings and harmonize with standards.
How Particle Counters Work: The Technology
Regardless of manufacturer, the technology behind these devices uses the principle of light scattering. In this blog, we look inside the equipment to see how particle counters work.
How Particle Counters Work: The Tiny Things We Can’t See
…inside a cleanroom we could measure flakes of skin, small pieces of silicon or metal, or fungal spores… Most particles are non-uniform in structure, and this poses a question: How is the size qualified?
Highlights of the New Lasair Pro Airborne Particle Counter
Paul Hartigan sits down with Blu Buquoy, both of Particle Measuring Systems (PMS), to discuss the new Lasair Pro airborne particle counter. Topics covered include an overview of the instrument and its features, how it meets the most up to date industry needs including regulatory requirements for calibration and data integrity, why the product was built and more.
Considerations and Steps for Building a Contamination Control Strategy – Series Part 4 of 4
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.
Build the Ideal Contamination Control Strategy
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.
Finding Root Causes of Contamination
In our previous blog in this series, we introduced you to the contamination control strategy (CCS), and why you need one. This time, we look at the quality risk management approach to preparing the CCS in order to design the ideal cleanroom for your Pharma process.
Consideration and Steps for Building a Contamination Control Strategy (CCS) – Series Part 1 of 4
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 will go into depth on both topics.
How Tubing Affects Particle Counts
Multiple mechanisms emerge when sample tubing of any length is placed between the sampling location and the particle counter inlet probe. By standardizing set-up variation where possible, these mechanisms are further classified into their principal loss mechanisms.
