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.
The Data Quality Concept – A New Challenge for Quality Experts
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.
Entraves dans les Sterilisateurs à la Vapeur
Cet article apporte des précisions sur la stérilisation thermique à la vapeur.
Le logiciel PMS est à l’abri de la vulnérabilité Apache Log4j
Les solutions logicielles Particle Measuring Systems ne sont PAS affectées par la vulnérabilité Java Apache Log4j récemment découverte.
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.
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.
Argonaut Manufacturing et PMS: une réussite en matière de monitoring de la contamination!
Lorsque Argonaut Manufacturing a mis en place sa nouvelle ligne de remplissage à la pointe de la technologie, ils voulaient la meilleure solution de monitoring de la contamination en temps limité. Regardez comment Argonaut et PMS ont travaillé ensemble pour mener à bien cette mission.
Data Trending Requirements Annex 1, Rev 12
Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three key components in the latest […]
Continuous Viable Air Monitoring per Annex 1 Draft, Rev 12
Continuous viable air monitoring is now a consideration, or even a recommendation in the new sections of Annex 1 draft, rev 12. Here I discuss this as well as the overall environmental monitoring requirements as part of Particle Measuring System’s series on the newest Annex 1 draft. Learn what Annex 1 is saying it will […]
Audits à distance dans cette nouvelle normalité
Covid-19 a amené le besoin de la manière de travailler de demain nous écraser aujourd’hui. Cette «nouvelle normalité» signifie que de nombreuses personnes travailleront à distance aussi souvent que possible. Cela présente des défis, y compris la façon de mener un audit. Heureusement, il existe une solution disponible aujourd’hui pour résoudre ce problème «nouveau normal» […]
