Guardtech Nordic AB Cleanroom Blog: GMP cleanrooms and Classification v Monitoring – are you doing it right?

This month the Guardtech Nordic AB team outlines the key difference between classification and monitoring

Ah, Annex 1 – the document that keeps cleanroom operators up at night. If you’ve ever debated whether your particle counter is your best friend or your worst enemy, this post is for you.

Let’s clear up one of the most common sources of confusion: the difference between classification and monitoring of particles in GMP-regulated cleanrooms.

Classification = The ‘Passport Check’

Think of cleanroom classification like airport security. It’s an occasional event, performed under strict conditions to verify your cleanroom meets the airborne particulate limits for its grade. ISO 14644-1 defines the method, and you better believe inspectors love to see the data.

Common mistake? Assuming classification results are a free pass for the next year. Nope! Your cleanroom can fail in real operations even if it passes classification.

Monitoring = The ‘Security Cameras’

While classification is a snapshot, environmental monitoring (EM) is the real-time detective work that ensures day-to-day compliance. It follows the rules of Annex 1 (2022), which stresses continuous monitoring in Grade A and at critical locations in Grade B.

Common mistake? Thinking you only need to monitor during production. Surprise! Annex 1 expects data trends, action levels, and, yes, meaningful reactions to excursions.

Final thought – don’t confuse the two!

Treat classification as your cleanroom’s passport, and monitoring as its health tracker. Mix them up, and you might just get a regulatory headache.