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.
Electronic Data in Pharmaceutical Manufacturing: Secure Data Transfer (Series Part 3 of 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 (séries, 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?
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.
