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Application Note

Particle Monitoring to Meet USP 797

Abstract

Particle Monitoring to Meet USP 797The current USP requirements for particle monitoring can be summarized as ‘to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications.’ Therefore, laminar flow hoods used in the manipulation of sterile product should meet ISO 5 limits. Background areas and ante rooms should meet either ISO 7 or ISO 8, depending on the activities performed in those areas.

To ensure that the designated zone is maintained in a clean state, a particle monitoring program should be designed based upon contamination risk to finished product quality. The ISO 14644-2 standard is referenced and is the recertification schedule for proving continued compliance. However, this is not a monitoring program. The Parenteral Drug Association (PDA) offers guidance pertaining to monitoring frequency which is based upon risk in manufacturing environments and is in accord with FDA requirements.

Interested in learning more? Complete the form on this page to receive a free copy of the Particle Monitoring to Meet USP 797 application note.

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Products

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

Industries

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

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Software / Data Management
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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