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

+45 7070 2855

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

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Aerosol Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gas Contamination Monitoring
    • Molecular Monitors
    • Software / Data Management
  • Education
    • Live Q&A Event – Scandinavia
    • Knowledge Center
      • Application Notes
      • Beginner Guide to Particle Counting
      • Videos
      • Particle Counting Webinars
    • Software / Data Management
    • Contamination Monitoring Blog
  • Applications
    • Industries
      • Pharma
      • Semi
      • Photonics & Optics
      • Aerospace
      • ISO 22716 Solutions for Cosmetics & Personal Care
    • USP 797
    • USP 788
    • ISO 21501-4
    • Parts Cleanliness Testing
    • Annex 1 Latest Draft Revision Updates
  • Service and Support
    • Product Calibration and Service
    • FMS/EMS Project Management Services
    • Customer Service
    • Advisory Service
  • About Us
    • Contact Us
    • Why PMS
    • Executives
    • Particle Measuring Systems’ Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • Credibility & Registrations
    • Trademarks & Patents
Application Note

Viable Environmental Monitoring Regulations for Sterility Assurance

Updates to the European Union (EU) Good Manufacturing Practice (GMP) Annex 1 are analyzed to better understand the industry’s future trends and possible changes in guidance around viable environmental monitoring for sterilizer assurance.

Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly. With the introduction of modern manufacturing concepts and an increasing number of industry standards, there is a need to adopt viable air monitoring in conjunction with the most recent regulatory trends.

Viable air monitoring is an essential part of the classification and monitoring program of ISO 5 (Grade A) critical environments. The right combination of strategies can lead to substantial improvements, contributing significantly to cost savings programs by reducing the cost of poor quality. Key considerations include:

  • Continuous vs. infrequent sampling
  • Real-time vs. traditional
  • Remote sampling vs. handheld devices
  • Classification vs. monitoring
  • Flexibility vs. single instrument

In this paper industry experts discuss these considerations and more.

Interested in learning more?
Complete the form to get the full paper.

Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • PMS Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobile, fixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

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

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Application Notes
  • Videos
  • 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:

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:

  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company