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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.

Get this paper now

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Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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