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Application Note

Choosing the Most Suitable Cleanroom Particle Sample Point Locations for Certification, Qualification and Monitoring Activities

As environmental monitoring system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).

The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored. The goal of this article is to identify the considerations, establish the most suitable locations for monitoring a process, and build a scientific rationale for that decision.

Particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification, and monitoring. Additionally, this paper covers considerations for sample point placement for each of these activities to achieve the most representative results for your process.

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2670 Greve, Denmark

T. +45 7070 2855
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Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • 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

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

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • 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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