Cleanroom Monitoring
ISO 14644 compliant environmental monitoring for pharmaceutical, biotech, and medical device cleanrooms. Real-time differential pressure, temperature, humidity, and particle monitoring.
Comprehensive Cleanroom Monitoring
ATEK provides complete environmental monitoring solutions for classified cleanroom environments. Our platform monitors all critical parameters required to maintain ISO classification and regulatory compliance.
From differential pressure cascades to particle counts, ATEK delivers continuous monitoring with immediate alerts when conditions deviate from specification.
- ISO 14644 cleanroom classification
- EU GMP Annex 1 compliance
- FDA cGMP requirements
- USP 797 and USP 800 environments
- Continuous particle monitoring
- Complete environmental trending
Monitoring Parameters
Complete environmental monitoring for classified spaces
Differential Pressure
Continuous monitoring of room pressurization and cascade pressures across cleanroom suites.
Temperature & Humidity
Precise environmental control monitoring for ISO classified environments.
Particle Counting
Integration with particle counters for real-time contamination monitoring.
Air Changes
Monitor air change rates and HVAC performance for classification compliance.
ISO Classifications Supported
Monitoring for all ISO 14644-1 cleanroom classes
| ISO Class | Particles ≥0.5µm | Typical Applications |
|---|---|---|
| ISO 5 | 3,520/m³ | Aseptic filling, Compounding |
| ISO 6 | 35,200/m³ | Sterile manufacturing |
| ISO 7 | 352,000/m³ | Buffer areas, Support |
| ISO 8 | 3,520,000/m³ | Anteroom, Gowning |
Frequently Asked Questions
How does ATEK monitor differential pressure?
ATEK uses precision differential pressure sensors that continuously monitor room-to-room and room-to-corridor pressure differentials. Alerts are triggered immediately if pressures fall outside specification, helping maintain classification.
Can ATEK integrate with particle counters?
Yes, ATEK integrates with major particle counter manufacturers including Lighthouse, Particle Measuring Systems, and TSI. Particle data is displayed alongside environmental parameters in a unified dashboard.
What cleanroom classifications does ATEK support?
ATEK monitors all ISO cleanroom classifications from ISO 5 through ISO 8. Our system tracks the parameters required to demonstrate ongoing classification compliance including particle counts, pressure, temperature, and humidity.
Does ATEK support EU GMP Annex 1 requirements?
Yes, ATEK provides continuous environmental monitoring required by EU GMP Annex 1, including automated alerts, complete data integrity, and audit trails for Grade A through D environments.
Maintain Your Cleanroom Classification
Get a personalized demo and see how ATEK can help ensure your cleanroom maintains classification compliance.