Introduction: Why Standards Define Cleanroom Success
Without measurable standards, cleanrooms would be impossible to validate. The ISO 14644 series provides the global benchmark for cleanroom classification, defining how many particles of specific sizes are allowed in controlled environments.
From semiconductor fabs to pharmaceutical sterile suites, understanding and applying ISO 14644 is essential for compliance and performance. This article provides a complete guide to ISO 14644 cleanroom classifications, their application across industries, and the role of airflow visualization and particle standards in meeting requirements.
Part 1: Overview of ISO 14644
ISO 14644-1: Defines cleanroom classes by airborne particle concentration.
ISO 14644-2: Specifies monitoring requirements.
ISO 14644-3: Describes test methods (airflow visualization, particle counting).
ISO 14644-5–10: Cover operations, design, separative devices, and nanotechnology.
Part 2: Cleanroom Classifications by Particle Counts
ISO cleanrooms are classified by maximum allowable particles per cubic meter:
| ISO Class | ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1.0 µm | ≥5.0 µm |
|---|---|---|---|---|---|---|
| ISO 1 | 10 | 2 | — | — | — | — |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO 7 | N/A | N/A | 352,000 | 83,200 | 29,300 | 293 |
ISO 5 is equivalent to EU GMP Grade A (aseptic processing).
Part 3: ISO vs GMP Annex 1
ISO 14644: Defines air cleanliness by particle concentration.
GMP Annex 1: Adds microbiological limits and requires airflow visualization for sterile zones.
Together, they form the regulatory foundation for pharmaceutical cleanrooms.
Part 4: Test Methods (ISO 14644-3)
Airflow Visualization
Required by Annex 1, airflow visualization (smoke studies) demonstrates unidirectional airflow in critical zones. Tools like the CRF4 Ultrapure Cleanroom Fogger provide dense, clean fog for video documentation.
Particle Counting
Airborne particle counters must be calibrated using PSL particle standards. This ensures traceability and compliance with ISO accuracy requirements.
Pressure Differentials
ISO 14644 requires documented pressure cascades to prevent cross-contamination.
Part 5: Industry Applications
Semiconductor
ISO 3–5: Lithography and wafer inspection.
ISO 6–7: Packaging and assembly.
Validation Tools: Silicon wafer standards.
Pharmaceutical
ISO 5 / Grade A: Filling zones.
ISO 7–8 / Grade C–D: Background rooms.
Annex 1 Impact: Mandates smoke studies with LN₂ foggers.
Medical Devices
ISO 7–8: Device assembly.
ISO 5: Required for implants and sterile packaging.
Metrology
ISO classes ensure accurate particle measurements for calibration labs.
Part 6: Continuous Monitoring Requirements
ISO 14644-2 mandates continuous monitoring of:
Particle counts (via automated counters).
Air pressure differentials.
Airflow patterns (visualized regularly).
Part 7: Common Pitfalls in Compliance
Misinterpreting ISO vs GMP equivalence.
Failing to requalify after equipment changes.
Using particle counters without calibration against PSL standards.
Poor documentation of smoke study videos.
Conclusion
The ISO 14644 standards form the backbone of cleanroom classification, monitoring, and compliance. By aligning ISO requirements with GMP Annex 1, industries ensure product quality and regulatory approval.
Ultimately, achieving compliance requires not just design, but proof—through airflow visualization, particle counting, and calibration standards. Applied Physics provides the tools, from cleanroom foggers to particle calibration standards, to ensure every cleanroom meets global standards.
