Question: “Can you speak to the requirements for monitoring Class D clean areas for viable and nonviable particulate? The regulations don’t make it black and white.” Answer: The regulations surrounding viable and nonviable monitoring of Class D clean areas…
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.
Classification limits are typically only used as a baseline during data collection for a new facility and EM program. After 6 months, it is a good time to do your data analysis and determine how to adjust alert and action based on your actual data.
Particle Measuring Systems believes that in the long run the periodic re-evaluation of the EM program will be enforced by authorities, but at the moment it seems the existence of an EM program is enough.
The original raw data is composed of the data and information stored in the system that generates the report. In your case, the computerized system is the raw data source that generates the printout and therefore, the raw data contained in this system must be available for data accuracy control.
Glen Slayter, Intel and Dan Rodier, Particle Measuring Systems (PMS) presented this paper at the 2020 Ultrapure Micro event. This Intel case study discusses the benefits and challenges of monitoring particles in ultrapure water (UPW) down to 20 nm. The presentation was the recipient of the #UPM2020 best presentation award. Only Particle Measuring Systems has proven and […]
When you perform your own FMEA, not only should you rank each value for probability, severity and detection, you should provide a rationale for choosing each value. Regulatory authorities need to understand your scientific rationale for the value chosen.