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Application Note

continuous particle monitoring systemAlarm Rationale for Continuous Particle Counting Systems

This paper, written by industry experts at Particle Measuring Systems (PMS) is a description of current good manufacturing practices (GMPs) and how they can be applied to a continuous monitoring system installed within a facility. This process should enable Quality and Production teams to establish new monitoring understandings and harmonization with standards. This review will look at the configuration of alert and action levels and potential reactions, and the reporting requirements of such systems.

Read this paper to learn more about:

  • How particle monitoring regulations have harmonized in the past decades
    Learn how Alert and action limit requirements started with the 2008 version of the EU Commission Annex 1 and are expanded on in the latest draft that now discuss Risk Assessment and Contamination Control Strategy (CCS).

  • Determining alarm and alert threshold limits
    Alert and action limits can be applied to reflect a particle trending condition referred to as an N:M, where the number of events (N) is within a population of events (M). Learn more about what this means and how to define and alarm vs. alert and which criteria to consider. 
  • The scope of the recent changes to GMP regulations
  • Alert and Action reports

Complete the Form to Download

RELEVANT CONTENT

Data Trending Requirements Annex 1, Rev 12

Trend Analysis of Total and Viable Particle Monitoring Data and Definition of Alert and Action Limits

Cleanroom Microbial Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations

Electronic Data in Pharmaceutical Manufacturing: Benefits of Paperless Reporting (Series Part 2 of 6)

 

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Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • PMS™ Knowledge Center
  • Software / Data Management
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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