In dieser sechsteiligen Blog-Reihe untersuchen wir häufig auftretende Probleme in Bezug auf Datenübertragung, Integrität, Analyse, Berichterstellung und Speicherung, auf die wir als Reinraumbesitzer und -benutzer täglich stoßen. Wir werden untersuchen, wie Automatisierungs- und elektronische Lösungen im Rahmen der Parameter der Aufsichtsbehörden und des cGMP zur Verbesserung der Effizienz und der Produktqualität beitragen können.
Elektronische Daten in der Arzneimittelherstellung: Vorteile der papierlosen Berichterstattung (Serie Teil 2 von 6)
In dieser sechsteiligen Blog-Reihe untersuchen wir häufig auftretende Probleme in Bezug auf Datenübertragung, Integrität, Analyse, Berichterstellung und Speicherung, auf die wir als Reinraumbesitzer und -benutzer täglich stoßen. Wir werden untersuchen, wie Automatisierungs- und elektronische Lösungen im Rahmen der Parameter der Aufsichtsbehörden und des cGMP zur Verbesserung der Effizienz und der Produktqualität beitragen können.
Steve Kochevar and John Kearns at Space Tech Expo 2019
Steve Kochevar, Aerosol and Gas Product Line Manager and John Kearns, Regional Sales Manager, showcased aerosol monitoring products at Space Tech Expo 2019.
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.
Faster, Simpler Surface Testing Solution for Biological Contamination
February 15, 2016, Boulder, CO – The newly released SurCapt™ Microbial Surface Detection Kit from Particle Measuring Systems (PMS) is an all-inclusive, ready-to-use solution which simplifies and quickens the process of environmental surface testing for biological contamination. The kit uses GreenLight® Technology for the rapid detection of microbial activity on cleanroom surfaces and the design reduces the likelihood of sample cross-contamination and mishandling by the operator.
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.
Gilberto Dalmaso, PhD Contributes to PHSS Book
Gilberto Dalmaso, Global Aseptic Process Development Manager at Particle Measuring Systems, has contributed to a newly released book with Rapid Microbial Methods (RMM), published by The Pharmaceutical and Healthcare Sciences Society. The book, titled PHSS Technical Mongraph No. 20 Bio-contamination, is a comprehensive review and best practice guide on bio-contamination characterization, risk profiling, control, monitoring and deviation management. It applies to controlled environments in GMP and non sterile applications where Bioburden control is required.
