Question: “What is the need of taking a nonviable particle count after a power shut down for an hour? Our Class C area is stabilizing after 30 minutes of a power cut?” Answer: There are several reasons for deploying your Nonviable Environmental Monitoring Program following a power outage…
Started in 1972 as a cloud microphysics company, PMS has grown into a solutions and thought leader for contamination monitoring and control within clean manufacturing facilities at sites around the globe.
A new challenge in Data Quality is approaching. The fourth industrial revolution (Pharma 4.0™) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies based on the concepts of Data Quality.
Particle Measuring Systems software solutions are NOT impacted by the recently discovered Java Apache Log4j vulnerability.
…any loss can be deemed to be unacceptable. However, let us look at the uncertainties, the acceptable errors for particle counting…
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…
…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.
…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?
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.
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.