Alarm Rationale for Continuous Particle Counting Systems

Alarm 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

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