Le dernier projet de l’annexe 1 propose plusieurs attentes mises à jour concernant le nettoyage, la décontamination et la désinfection. Definitions Nettoyage (NOUVEAU) Un processus pour éliminer la contamination, par exemple résidus de produits et résidus de désinfectants. Décontamination Processus global d’élimination ou de réduction de tout contaminant (produit chimique, déchet, résidu ou micro-organisme) d’une […]
Comment obtenir de la qualité par le design (QbD) dans une nouvelle ligne de remplissage pharmaceutique: Intro et réglementation (Partie 1 d’une série de 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.
Localiser une source de particules avec le compteur de particules aérosol portable Handilaz® Mini II
Pinpointing particle sources can be a challenge in cleanrooms and laboratory flow equipment where the movement of clean air can mask particle generators such as faulty filters, motors, robots, operators and residual dust.
Le digital en fabrication pharmaceutique: transfert de données sécurisé (série partie 3 de 6)
In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. We’ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.
Le digital en fabrication pharmaceutique: avantages des rapports sans papier (série, partie 2 de 6)
In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. We’ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.
Laborama 2019 – 14-15 mars, Bruxelles
Le 14 et 15 mars dernier, Particle Measuring Systems® a participé à la 20e édition du salon Laborama à Bruxelles Expo.
Le rapport consacré à la surveillance de la contamination dans les systèmes de distribution de produits chimiques a beaucoup intéressé les participants au symposium UCPSS 2018
« Stratégies avancées d’analyse des données pour comprendre la contamination particulaire dans les systèmes de distribution de produits chimiques »
Learn where to place sample points for certification
As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).
A Comparison of Particle Counting Solutions for UPW
Through continuous process and equipment advancements, semiconductor manufacturers are approaching 14 nm feature sizes and heading even smaller, while hard-disk drive fly heights are now less than 10 nm. This ever-reducing device feature size requires comparable cleanliness-level improvements in ultrapure water (UPW). UPW purity is especially important with its high use in direct contact with wafers as a final cleaning and rinsing agent in many production steps. Leveraging recent advances in laser optics and detector technology, UPW particle concentration ≥20 nm (≥9 nm for metallic particles) can be effectively monitored.
Are your particle counters ISO 14644-1 compliant?
Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?
