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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 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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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:

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