• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+45 7070 2855

  • Youtube
  • Twitter
  • Linkedin
  • Denmark
    • 中文
    • 台灣
    • Singapore
    • English
    • English / CH
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português
    • Español
Newsletter

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Aerosol Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gas Contamination Monitoring
    • Molecular Monitors
    • Software / Data Management
  • Education
    • Knowledge Center
      • Application Notes
      • Beginner Guide to Particle Counting
      • Videos
      • Particle Counting Webinars
    • Software / Data Management
    • Contamination Monitoring Blog
  • Applications
    • Industries
      • Pharma
      • Semi
      • Photonics & Optics
      • Aerospace
      • ISO 22716 Solutions for Cosmetics & Personal Care
    • USP 797
    • USP 788
    • ISO 21501-4
    • Parts Cleanliness Testing
    • Annex 1 Latest Draft Revision Updates
  • Service and Support
    • Product Calibration and Service
    • FMS/EMS Project Management Services
    • Customer Service
    • Advisory Service
  • About Us
    • Contact Us
    • Why PMS
    • Executives
    • Particle Measuring Systems’ Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • Credibility & Registrations
    • Trademarks & Patents
Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring 

Understanding ISO 14644-2:2015 Cleanroom Monitoring

After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

This document underlines the major changes between the previous version of ISO 14644-2 and the latest,
second edition, dated December, 12th 2015.

A specific approach to the best practices to be adopted for an
efficient and compliant cleanroom monitoring process are discussed.

In combination with the revision to Part 1. Classification of air cleanliness by particle concentration of ISO 14644-1:2015, the ISO Technical Committee TC 209 has been working on the update to the basic airborne cleanliness monitoring guidelines contained in ISO 14644-2.

The TC 209 community voted in favor of the revision to update and improve the standard specifically to:

  • Simplify and clarify requirements and guidance tables that specify frequency of testing and monitoring of cleanrooms used to demonstrate continued compliance with the cleanliness classification
  • Refine how these intervals may be extended, provided that automated monitoring systems show the cleanroom is under control
  • Provide new guidance on aspects that should be considered when configuring a monitoring system for a cleanroom

The new standard’s introduction also lists the goals of the ISO 14644-2, when successfully applied:

  • Emphasize the needs and advantages of a planned cleanroom contamination monitoring
  • Provides the method for a correct particles contamination alarm and warning limits setting, based on a careful evaluation of data trends
  • Define the differences between a simple periodic cleanroom control and a more intensive/complex monitoring strategy
  • Enhance the installation and process knowledge, as to improve the risk assessment evaluation and a faster reaction to any unexpected cleanroom performance
  • Concretely reduce the operation cost by preventing production loss

Download the paper to learn more..

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

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

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Application Notes
  • Videos
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • 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:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • 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

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

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • 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:

  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company