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Annex 1 Draft: Answers to Common Questions

Concerned about how Annex 1 might affect you?

Industry experts answer over 40 common Annex 1 draft questions including:

  • During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
  • Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
  • Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
  • Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?

Get answers to these and other questions by filling out the form and downloading the paper. If you can’t find the answer to your question, the contact information for an Annex 1 expert is included at the end of the paper.

Get started now on meeting the new EU GMP Annex 1. Particle Measuring Systems can help you with:

    • Advisory Services: Risk Assessments, Quality Risk Management and more
    • Software
    • viable and non viable particle counters

 

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Particle Measuring Systems EN-CH

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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:

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