March 15, 2016 12:28:31 PM

Learn where to place sample points for certification

Written by Nina Morton

Sample-Points-Pharma

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.).

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February 24, 2016 10:20:02 AM

A Comparison of Particle Counting Solutions for UPW

Written by Nina Morton

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.

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February 15, 2016 09:21:32 AM

Faster, Simpler Surface Testing Solution for Biological Contamination

Written by Nina Morton

Faster, Simpler Surface Testing Solution for Biological Contamination

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.

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February 11, 2016 11:45:42 AM

Are your particle counters ISO 14644-1 compliant?

Written by Nina Morton

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?

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February 4, 2016 09:55:06 AM

New paper: ISO 14644 Revisions Summary

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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.

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January 27, 2016 08:18:25 AM

Gilberto Dalmaso, PhD Contributes to PHSS Book

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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.

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