Particle Measuring Systems has been an active supporter of the Parenteral Drug Association (PDA) over the years. Recently, we sponsored a course on environmental monitoring that was held at the PDA Training & Research Institute at PDA’s headquarters in Bethesda, MD. The Institute’s courses cover a broad range of subject areas reflecting PDA’s core competencies — aseptic processing, biotechnology, environmental monitoring, filtration, microbiology, quality/regulatory affairs, and validation; as well as specialized areas such as cold chain, lyophilization, pre-filled syringes and visual inspection.
Archives for February 2016
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.
Particle Measuring Systems just completed another successful MD&M show with strong results, meeting with current clients and reaching out to new businesses. Our show message was As experts in good manufacturing practice regulations (GMPs), microbiology and environmental monitoring, we help you assure sterility when and where you need it most. Supporting this statement, PMS brought a comprehensive range of microbial and particle products including the BioCapt Single Use Microbial Impactor and the MiniCapt Mobile Air Sampler. The Lasair III particle counter rounded out the contamination monitoring solutions. As a special attraction this year, PMS provided a sneak peek to the soon to be released SurCapt Microbial Surface Detection Kit (learn more next week).
Carrying on a global Semicon tradition, Particle Measuring Systems (PMS) had a notable booth presence at Semicon Korea in January. The overall theme of the booth was “Global experts in contamination monitoring solutions since 1972.” PMS had over 220 visitors from a large variety of semiconductor companies. Most of the booth visitors were from Korea, but there were also visitors from China, Taiwan, Japan, Malaysia, America, and Europe.
Particle Measuring Systems Releases the SurCapt™ Microbial Surface Detection Kit.
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.
Mark Hallworth will be presenting in the Barrier Track at ISPE 2016 Aseptic Processing Technology Conference, held Feb. 29 – March 1 in Arlington, Virginia. Mark is the Pharmaceutical Sales Manager, North America, for Particle Measuring Systems, and has managed the design, installation and validation of more than 300 environmental monitoring system projects worldwide. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has authored many papers including Choosing the Most Suitable Non-Viable Sample Point Locations. For his presentation at ISPE, he will be discussing environmental monitoring challenges in isolator technologies.
Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?
Register now! Date: March 1, 2016 Time: 9:00 AM PST, 12:00 PM EST, 18:00 GMT+1 Personnel pose the greatest risk of false positives in aseptic processing. Investigations are required when microbial activity is detected, along with the risk of batch loss. Learn a new approach that eliminates false positives and costly investigations by preventing direct […]
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.
For immediate release
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NEW MICROBIAL TESTING TECHNOLOGY FOR CLEANROOMS ANNOUNCED BY MOCON, PARTICLE MEASURING SYSTEMS
Minneapolis (February 3, 2016) – Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than traditional solutions. The capability is a result of a global marketing agreement between MOCON, Inc. (NASDAQ: MOCO) and Particle Measuring Systems (PMS).