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News Blog

May 6, 2022 05:13 PM

FAQ’s: Class D clean area viable and non viable monitoring requirements

Written by PMS

Question: “Can you speak to the requirements for monitoring Class D clean areas for viable and non viable particulate. The regulations don’t make it black and white.” Answer: The regulations surrounding viable and non viable monitoring of Class D clean areas…

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May 5, 2022 09:49 PM

FAQ’s: Non viable particle recovery verification after a power outage

Written by PMS

Question: “What is the need of taking a non-viable particle count after a power shut down for an hour. Our Class C area is stabilizing after 30 minutes of a power cut?” Answer: There are several reasons for deploying your Non-Viable Environmental Monitoring Program following a power outage…

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April 18, 2022 06:43 PM

As Particle Measuring Systems reaches its 50th Anniversary, we look back on half a century of innovations and growth.

Written by Stacy Duncan

Started in 1972 as a cloud microphysics company, PMS has grown into a solutions and thought leader for contamination monitoring and control within clean manufacturing facilities at sites around the globe.

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April 7, 2022 02:40 PM

The Data Quality Concept – A New Challenge for Quality Experts

Written by Maurizio Della Pietra

A new challenge in Data Quality is approaching. The fourth industrial revolution (Pharma 4.0™) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies based on the concepts of Data Quality.

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December 28, 2021 04:48 PM

PMS Software is Apache Log4j Vulnerability Immune

Written by PMS

java log4j vulnerability

Particle Measuring Systems software solutions are NOT impacted by the recently discovered Java Apache Log4j vulnerability.

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December 1, 2021 09:30 PM

Classification and Qualification Commonly Asked Questions

Written by PMS

Cleanroom Classes

Classification limits are typically only used as a baseline during data collection for a new facility and EM program. After 6 months, it is a good time to do your data analysis and determine how to adjust alert and action based on your actual data.

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November 24, 2021 09:30 PM

EU GMP Annex 1 Commonly Asked Questions

Written by PMS

EU GMP Annex 1 contamination control

Particle Measuring Systems believes that in the long run the periodic re-evaluation of the EM program will be enforced by authorities, but at the moment it seems the existence of an EM program is enough.

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November 17, 2021 10:00 PM

21 CFR Part 11 and Going Paperless Commonly Asked Questions

Written by PMS

CAS P

The original raw data is composed of the data and information stored in the system that generates the report. In your case, the computerized system is the raw data source that generates the printout and therefore, the raw data contained in this system must be available for data accuracy control.

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November 10, 2021 09:43 PM

Intel Case Study: Ultrapure Water UPW Contamination Control / 20 nm Particle Counting

Written by Nina Morton

Glen Slayter, Intel and Dan Rodier, Particle Measuring Systems (PMS) presented this paper at the 2020 Ultrapure Micro event. This Intel case study discusses the benefits and challenges of monitoring particles in ultrapure water (UPW) down to 20 nm. The presentation was the recipient of the #UPM2020 best presentation award.   Only Particle Measuring Systems has proven and […]

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November 10, 2021 09:30 PM

FMEA Commonly Asked Questions

Written by PMS

FMEA-matrix

When you perform your own FMEA, not only should you rank each value for probability, severity and detection, you should provide a rationale for choosing each value. Regulatory authorities need to understand your scientific rationale for the value chosen.

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Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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