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…
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.
Per sottolineare l’importanza del COP26, Particle Measuring Systems sta incoraggiando il coinvolgimento dei nostri dipendenti per evidenziare il ruolo che possiamo svolgere individualmente e come squadra nel ridurre il nostro impatto ambientale. Come parte del nostro impegno per la sostenibilità, a tutti i dipendenti della Particle Measuring Systems è stata offerta l’app Giki per aiutarli […]
New flow imaging technologies and therapeutic protein solutions widened the scope of <1788>. Three primary technologies are discussed in each of the sub-parts of the guidance document…
Part of Particle Measuring Systems’ role in making the world make the world cleaner, healthier & more productive As part of the Spectris PLC family of businesses, we aim to deliver value to society by providing solutions that make the world cleaner, healthier, and more productive. As part of Spectris, Particle Measuring Systems (PMS) supports […]
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.
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.
…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?