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.
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.
Monitoring fréquent ou continue des particules? (Série Partie 2 sur 4)
Dans cette série de blogs, nous examinons les termes communs et les considérations initiales pour sélectionner un moniteur de particules d’aérosol pour diverses applications
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.
New paper: ISO 14644 Revisions Summary
The recent revision of ISO 14644-1 and-2 has introduced several changes for cleanroom classification and monitoring guidelines. This paper highlights the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.