Cleanrooms & Annex 1
Contamination control, cleanroom behaviour, EM and Annex 1 principles.
The 2022 revision of EU GMP Annex 1 significantly raised expectations for contamination control across pharmaceutical manufacturing, and cannabis facilities are no exception. This section covers cleanroom classification, environmental monitoring programme design, airflow visualisation (smoke studies), isolators versus RABS, and building a facility-wide Contamination Control Strategy that ties these elements together.
For a complete section-by-section walkthrough of EU GMP Annex 1 (2022), see the Annex 1 Complete Guide.
Cleanrooms & Annex 1 — where to start
Contamination control, cleanroom design, EM and Annex 1 principles. Use the resources below to learn, assess your readiness and take the next step.
Cleanroom Classification Explained
ISO classes, EU GMP grades, at-rest and in-operation states, classification testing and routine monitoring for medical cannabis facilities.
Read article → PUBLICGMP Readiness Index™
Assess your facility's cleanroom and contamination control readiness — free, 2 minutes, instant score.
Open → FREECCGP Certification
The core EU GMP compliance certification covering contamination control, Annex 1 and cleanroom management.
View course → NEXT STEPCCS Template
Download the ECI Contamination Control Strategy template — Annex 1 (2022) aligned with 35-failure-mode FMEA.
Open → AVAILABLEArticles in this section
Cleanroom Classification Explained
Understand ISO classes, EU GMP grades, at-rest and in-operation states, classification testing and routine monitoring for medical cannabis facilities.
Environmental Monitoring Explained
Design and operate a risk-based EM programme covering viable monitoring, non-viable monitoring, alert/action limits, trends and excursions.
Smoke Studies / Airflow Visualisation
Understand airflow visualisation studies, dynamic scenes, pressure cascades, interventions and acceptance principles for cleanroom contamination control.
Contamination Control Strategy (CCS)
Build a risk-based contamination control framework linking facility design, HVAC, personnel, cleaning, EM, smoke studies, validation and quality systems.
Isolators vs RABS for Cannabis Manufacturing
A technical comparison of isolators and Restricted Access Barrier Systems — design differences, GMP requirements and when each is appropriate.
Test your knowledge
Complete the free GMP Lite Assessment to benchmark your current readiness across ten quality dimensions.