ISO 14644 and healthcare cleanrooms
Cleanroom classes are defined by particle counts at specified channels (typically ≥0.5 µm and ≥5 µm). Healthcare-pharmacy environments use Grade A/B/C/D zoning with associated cleanroom classes and operational state requirements. Monitoring must be sized to provide enough data to demonstrate ongoing classification, not just commissioning compliance.
What we monitor
Continuous particle counts at critical and supporting positions, pressure differentials between grades, temperature and humidity within design bands, and air change rates verified periodically. Alarms route to both estates and the responsible pharmacist or quality lead.
Linking cleanroom data to validation
Continuous data and periodic full validation work together. We map our monitoring output into the cleanroom validation file so renewal of classification is a review exercise rather than a from-scratch rebuild.
Next step
Talk to a healthcare air quality specialist
Independent technical support for hospital ventilation, HTM 03-01 compliance, environmental monitoring and infection control air quality.