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

+41 79 261 67 41

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

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Advisory Services
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
Blog: Cleanroom Monitoring Regulations

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 (PMS) continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

ISO 14644-1:2015 Cleanroom monitoring

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

Complete the form to download the paper 

More regulatory information

ISO 14644-1/2: 2015 Insights & Solutions

Annex 1 Latest Draft Revision Updates

21 CFR Part 11 & Data Integrity

ISO 21501-4 Particle Size Distribution

Products

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

Industries

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

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

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:

Products

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

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

Education and Training

  • 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:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company