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Application Note

Viable Non-Viable Environmental Monitoring to Meet USP 797

USP 797 SolutionsAccording to USP 797, critical areas must continuously meet ISO Class 5 or better conditions for 0.5 μm particles and must exclude microbial contamination during compounding of CSPs. These classifications ensure that a designated zone is maintained in a clean state. The monitoring program is designed based upon contamination risk to finished product quality.

An effective environmental monitoring program provides meaningful information on the quality of the compounding environment and any environmental trends in surrounding areas.

In addition, an effective environmental monitoring program will identify potential routes of contamination, allowing for implementation of corrections to prevent CSP contamination.

The paper includes information on the most recent 797 updates and recommendations.

COMPLETE THE FORM TO ACCESS THE PAPER

Particle Measuring Systems can help you meet your USP 797 monitoring requirements with these solutions:

  • Lasair III for Particle Counting
  • MiniCapt Mobile Microbial Air Sampler
  • BioCapt Single-Use Microbial Impactor for viable monitoring.

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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:

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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