Understanding ISO 14644-1:2015
ISO 14644-1:2015 establishes the international standard for classification of air cleanliness in cleanrooms and associated controlled environments. Published by the International Organization for Standardization, this standard is fundamental to operations across pharmaceutical manufacturing, semiconductor fabrication, biotechnology research, and medical device production.
The Classification System
The standard defines nine ISO classes (1 through 9) based on the maximum concentration of airborne particles at specified sizes from 0.1 µm to 5 µm per cubic meter of air. The following shows maximum particle concentrations at ≥0.5 µm:
- ISO Class 1: classified at ≤0.2 µm only (≤10 particles/m³ at ≥0.1 µm)
- ISO Class 2: classified at ≤0.3 µm only (≤100 particles/m³ at ≥0.1 µm)
- ISO Class 3: ≤35 particles/m³
- ISO Class 4: ≤352 particles/m³
- ISO Class 5: ≤3,520 particles/m³ (common for pharmaceutical aseptic operations)
- ISO Class 6: ≤35,200 particles/m³
- ISO Class 7: ≤352,000 particles/m³
- ISO Class 8: ≤3,520,000 particles/m³
- ISO Class 9: ≤35,200,000 particles/m³ (least stringent, operational state only)
Key Requirements
Particle Counting and Classification: Cleanrooms must be classified through particle counting procedures using calibrated optical particle counters. The counting protocol specifies sampling locations, sample volumes, and statistical analysis methods to ensure accurate classification.
Monitoring and Control: Once classified, cleanrooms must be monitored per ISO 14644-2 to provide evidence of continued compliance. Periodic reclassification is typically performed on an annual basis, and continuous monitoring can extend time intervals between formal classifications.
Occupancy States: Classification must specify the occupancy state — as-built (no equipment or personnel), at-rest (equipment operating, no personnel), or operational (equipment and personnel present). ISO Class 9 is only applicable for the operational state.
Data Documentation: All monitoring data must be recorded, maintained in a traceable format, and available for verification during regulatory inspections and audits.
How ATEK Supports ISO 14644-1 Compliance
ATEK’s environmental monitoring platform is specifically designed to meet the monitoring and documentation requirements of ISO 14644-1:2015. Our integrated approach combines equipment integration, data management, and regulatory documentation capabilities.
Real-Time Environmental Monitoring
ATEK integrates with particle counting equipment and environmental sensors to provide real-time monitoring of all critical cleanroom parameters:
Particle Concentration Tracking: Automatic collection and analysis of particle count data with real-time classification status calculation. The system continuously compares measured particle concentrations against the facility’s ISO classification limits.
Multi-Parameter Integration: Simultaneous monitoring of temperature, humidity, differential pressure, and other environmental parameters. This comprehensive view ensures cleanroom conditions remain within specification across all critical parameters.
Automated Alerts and Notifications: Immediate alerts when any parameter approaches or exceeds specification limits, enabling rapid corrective action before the cleanroom classification is compromised.
Compliance Documentation
ATEK automatically generates the documentation required for ISO 14644-1 compliance verification:
Immutable Records: Every data point is recorded with timestamp, user identification, and system verification. Records cannot be altered or deleted, providing the audit trail required for regulatory submission.
Calibration Tracking: Comprehensive tracking of particle counting equipment calibration status, expiration dates, and maintenance records. This documentation proves that monitoring data was collected using properly calibrated instruments.
Classification Reports: Automated generation of ISO classification status reports demonstrating sustained compliance with the standard’s particle concentration limits.
Monitoring History: Complete audit trail of all monitoring activities, including sampling locations, frequency, dates, times, and personnel responsible. This history demonstrates consistent adherence to monitoring procedures.
Operational Efficiency
Beyond compliance, ATEK improves cleanroom operational efficiency:
Trend Analysis: Historical data analysis identifies emerging trends before they become compliance issues, enabling predictive maintenance and operational adjustments.
Data Export: Export monitoring data in formats suitable for regulatory submission, internal reporting, and statistical analysis.
Flexible Configuration: Easily configure monitoring schedules, alert thresholds, and sampling locations to match facility requirements and operational changes.
Implementation Best Practices
Establish Clear Monitoring Protocols
Define monitoring locations based on the areas critical to product quality and areas most susceptible to contamination. Higher ISO classes require more stringent monitoring protocols with additional sampling points.
Calibrate Equipment Regularly
Maintain a calibration schedule for all particle counting equipment. ATEK tracks calibration status and sends alerts before calibration expiration, ensuring monitoring data comes from properly qualified instruments.
Document Cleanroom History
Establish baseline cleanroom performance during initial classification. Use ATEK’s trending capabilities to monitor performance over time and identify when requalification may be needed.
Define Corrective Action Triggers
Establish clear thresholds for particle concentration levels that trigger investigation and corrective action. ATEK can be configured to automatically alert designated personnel when these thresholds are approached.
Integrate with Quality Systems
Connect ATEK monitoring data with your quality management system to provide comprehensive environmental control documentation supporting product quality and regulatory compliance.
Regulatory Context
ISO 14644-1:2015 is referenced in numerous regulatory requirements:
- FDA CGMP (21 CFR Part 211): Requires cleanroom controls for pharmaceutical manufacturing
- EU Annex 1: The European guideline for pharmaceutical aseptic operations references ISO 14644-1
- GAMP 5: Good Automated Manufacturing Practice guidance incorporates ISO 14644 requirements
- Pharmaceutical Operations Standards: Industry-specific requirements for semiconductor and electronics manufacturing also reference ISO 14644-1
Organizations operating in multiple regions face converging requirements for cleanroom classification and monitoring. ATEK’s comprehensive monitoring platform enables simultaneous compliance with all applicable standards.
Conclusion
ISO 14644-1:2015 compliance requires robust environmental monitoring, accurate documentation, and sustained operational control. ATEK’s platform provides the integrated technology infrastructure needed to meet these requirements efficiently and reliably. By automating particle counting data collection, environmental parameter monitoring, and regulatory documentation, ATEK reduces the manual burden of compliance while improving confidence in cleanroom integrity and product quality.