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Application Note

ISO 17141 microbial monitor biocapt impactor

A Review of EN ISO 17141, ISO 14698 and Particle Measuring Systems’ Microbial Instrumentation Conformance

There are two sections to the new European standard, EN 17141:

  • Normative: Those parts that are prescriptive. They should be followed to demonstrate compliance with the standard.
  • Informative: Those parts that are descriptive. They aid the reader understand the concepts presented in the standard.

The normative chapters describe the establishment of microbiological control, in identifying the risks associated with environments and processes and how to ally a monitoring plan to those identified risks. Those aspects are covered in a separate technical review. The informative chapters offer guidance on how to apply the monitoring plans to meet specific regulated industrial applications. The standard is also very clear that additional regulatory requirements may be made on these industries by local and international regulatory bodies. It is the Informative Annexes E and F that identify the apparatus that can be used to measure within these applications. Guidance is given on selecting the most suitable solution for an application and verifying and/or validating their suitability.

Read this paper to learn more about:

  • d50 efficiency calculations
  • a comparison of ISO 14698-1/2:2003 to EN 17141:2020
  • requirements of volumetric air samplers

Download the paper by filling out the form on this page.

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Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
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Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

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  • PMS™ Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

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