• 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

  • Linkedin
  • Twitter
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
News Blog
May 12, 2020 06:18 AM

Cleanroom Qualification

Written by Maurizio Della Pietra

Part 2 of 6 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft

Cleanroom QualificationThe definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification.

Qualification methodologies are identified in EU GMP Annex 15 and all verification must comply with the testing methodologies in ISO 14644-3:2019.

Cleanroom Qualification Verification

The next item to consider is which verifications are needed for cleanroom classification?

First, it is important to understand that microbial contamination for airborne and surface must be measured both “at-rest” and “in-operation” states.

Next, the number and location of sampling points should be based on a documented risk assessment. This is not the same RA for microbial monitoring. This RA is to create a microbial map that characterizes the cleanroom.

 Re-qualification

Cleanroom requalification

Re-qualification must be carried out as a minimum following these timelines:

  • A & B: at least every 6 months
  • C & D: at least every 12 months

The new Annex draft also specifies the re-qualification tests needed, and that after changes or an extraordinary event, the cleanroom must be re-qualified.

Looking for Cleanroom Qualification and other Clean Air Services? Learn about our Cleanroom GMP Services or Request a Quote. 

Want to read more? Read our other posts in this series:

  • Part 1 of 6, May 8, 2020: Cleanroom Classification
  • Part 2 of 6, May 13, 2020: Cleanroom Qualification  (you are here!)
  • Part 3 of 6, May 19, 2020 Cleanroom Monitoring
  • Part 4 of 6 May 22, 2020: Cleanroom Verification
  • Part 5 of 6 May 26, 2020: Advisory services for your cleanroom RA and steps
  • Part 6 of 6 May 29, 2020: Facility and data management solutions

See links to additional supporting resources below: 

  • Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
  • Video: Cleanroom Monitoring Updates Discussion
  • Blog: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line

Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.

Filed Under: Cleanroom Classification Qualification Tagged With: annex 1, facility monitoring, gmp

Archives

  • January 2021 (1)
  • December 2020 (1)
  • November 2020 (3)
  • September 2020 (4)
  • August 2020 (1)
  • July 2020 (3)
  • June 2020 (3)
  • May 2020 (6)
  • April 2020 (12)
  • March 2020 (2)
  • February 2020 (3)
  • January 2020 (1)
  • December 2019 (2)
  • November 2019 (3)
  • June 2019 (1)
  • May 2019 (1)

Subscribe to our news feed!

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