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Cleanroom Classification, Qualification, Monitoring

Annex 1 Requirements for Particle Monitoring

Cleanroom classification: particle monitoring for verification and certification

Get the latest Annex 1 draft insights on definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring.

In this paper, Maurizio Della Pietra, MPhys, of Particle Measuring Systems (PMS), discusses various aspects of Cleanroom Classification, qualification and monitoring including:

  • When a Risk Assessment is important
  • Which particle sizes to measure
  • Definitions such as cleanroom classification vs. cleanroom qualification
  • Requirements for re-qualification
  • Cleanroom monitoring and it’s relationship to cleanroom classification and qualification
  • Cleanroom monitoring verification
  • Solutions to meet the new Annex 1 expectations

 

Interested in learning more on cleanroom classification, qualification, and monitoring?
Complete the form to get the full paper.

 

Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • PMS Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobile, fixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located.

RELEVANT CONTENT

EU GMP Annex 1 – Insights and Updates

Selecting the Best Particle Counter for Your Needs (Series Part 1 of 4)

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Surrounding Areas (Series Part 2 of 6)

Cleanroom Qualification

Continuous Viable Air Monitoring per Annex 1 Draft, Rev 12

Data Trending Requirements Annex 1, Rev 12

Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1

The New Handilaz® Mini II handheld particle counter for versatility and convenience.

Applying Quality Risk Management to Develop an Isolator Filling Line

Particle Measuring Systems Announces the Release of the Lasair® Pro Airborne Particle Counter

Cleanroom Classification

 

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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® Certificate of Analysis (CofA)
  • 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

  • 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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