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» […]
Particle Counter Data and Cleanroom Solutions in the New Normal: Part 1
Particle Counter Data Remote Access, 21CFR11 Electronic Signatures…. The new normal is here. Companies want to protect their employees, keep pharmaceutical manufacturing running, while working efficiently and effectively and getting product to market safely and quickly. This presents a wide range of challenges that we did not face at the beginning of 2020. Fortunately, Particle […]
Incubation sur plaque microbiologique et évaluation des risques pharmaceutiques
Le nouveau projet de l’annexe 1 des BPF de l’UE, Rev 12, spécifie les exigences d’une évaluation des risques pharmaceutiques pour définir les conditions microbiologiques appropriées des plaques. Ce blog traite de ces exigences pour utiliser une évaluation des risques, puis fournit une interprétation sur la façon de l’appliquer et de l’utiliser à différentes étapes […]
Cleanroom Qualification
Part 2 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies […]
Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6)
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
Stratégie de Contrôle de la Contamination et Annexe 1
Science vs standardisation: faut-il justifier ou suivre les règles a l’aveuglette. Les attentes des nouveaux auditeurs L’annexe 1 exige la conception d’une stratégie efficace de contrôle de la contamination (CSC) basée sur une évaluation scientifique pour comprendre le processus et appliquer les principes de gestion des risques. Le dernier projet d’annexe 1 utilise fréquemment les […]
