Particle Measuring Systems (PMS)

Cleanroom Standards, Classification and Compliance - Quick-Reference Guide

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Mar. 15, 2025

Need a fast way to check cleanroom contamination limits?
Get your free quick-reference guide here.

That’s why Particle Measuring Systems has created the Cleanroom Standards At-a-Glance Cards, free quick-reference tool designed to help you navigate cleanroom standards with ease.

Download Your Free Clean Room Compliance Cards Here

In pharmaceutical manufacturing, cleanroom compliance is critical—but keeping up with evolving global regulations can be overwhelming. From EU GMP Annex 1 to ISO 14644-1, the standards governing cleanroom classification and contamination control are complex and constantly updated. Whether you’re managing cleanroom qualification, regulatory compliance, or contamination monitoring, you need fast access to accurate information—without spending hours searching through lengthy regulatory documents.

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Cleanroom standards differ between ISO, FDA, and EU GMP, making it challenging to compare classifications, understand particle count limits, and ensure regulatory compliance. Our quick-reference cards provide:

  • Side-by-side cleanroom classification comparisons
  • Microbial and particle contamination limits at a glance
  • Regulatory insights from ISO 14644-1, EU GMP Annex 1, and more
  • A time-saving tool to improve compliance and contamination control

Instead of digging through multiple documents, get the key information you need—all in one place

These two full-page cards provide a concise, easy-to-read breakdown of essential cleanroom requirements, including:

Cleanroom Classification Levels – Compare ISO and EU GMP particle count limits
Microbial Contamination Limits – Know the CFU thresholds for different cleanroom grades
Regulatory Guidelines Breakdown – Stay informed on key compliance requirements

Whether you work in quality assurance, regulatory affairs, or cleanroom operations, this tool is designed to help you maintain compliance and audit readiness.

With updates to EU GMP Annex 1 focusing on a risk-based approach to contamination control, now is the time to ensure you have the right tools to stay compliant. Don’t risk falling behind on the latest cleanroom requirements.

Access to accurate, up-to-date regulatory information is key to ensuring cleanroom compliance, product safety, and operational efficiency.