• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+41 71 987 01 01

  • Youtube
  • Linkedin
  • English / CH
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português, Brazil
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • PMS™ Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility, Sustainability, Health & Safety
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
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.

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

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:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • 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

  • PMS™ 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:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2022 - Particle Measuring Systems is a Spectris company