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Without measurement there is no control
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Application Note

Advice for EU GMP 0.5 and 5.0 μm Particle Limits

Abstract

Advice for EU GMP 0.5 and 5.0 μm Particle LimitsThe EU GMP Annex 1 Guide requires continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counting system, such as the Airnet II or IsoAir 310P. This is because the risk of contamination of finished product is very high and the greatest risk, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also a random generator of those particles. These are not all inert particles; some will be viable, which pose an even greater risk to the finished aseptic product. Since we cannot control the risk, we must measure it, because “without measurement there is no control”

Interested in learning more? Complete the form on this page to receive a free copy of the Advice for EU GMP 0.5 and 5.0 μm Particle Limits application note.

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Particle Measuring Systems

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

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

Industries

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

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • USP 788
  • Parts Cleanliness Testing
  • EU GMP Annex 1
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College
  • Software / Data Management
  • Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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