To maintain these controlled environments, international standards have been established to classify cleanrooms based on their cleanliness levels. The ISO 14644 - 1, 2, 3 series defines cleanroom classifications, specifying the maximum allowable airborne particles per cubic meter. In this blog, we will break down the different ISO cleanroom classifications and what they mean for your operations.

Understanding ISO 14644 Cleanroom Standards:-

The ISO 14644-1 standard defines cleanrooms based on airborne particle concentration levels. ISO 14644-1 classifies cleanrooms from ISO Class 1, which has the highest level of cleanliness, to ISO Class 9, which allows for the most particles. The lower the class number, the fewer particles are allowed in the cleanroom environment.

Key ISO Cleanroom Requirements

1. Particle Control
– Cleanrooms must maintain specific particle limits based on their classification.

2. Air Changes per Hour (ACPH)
– Higher ISO classes require more frequent air filtration and changes.

3. HEPA/ULPA Filtration
– High-efficiency particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters remove contaminants.

4. Environmental Monitoring
– Regular particle count testing ensures compliance.

5. Personnel and Gowning Protocols
– Cleanroom personnel must follow strict gowning procedures to minimize contamination.

Why ISO Cleanroom Standards Matter

• Regulatory Compliance
– Ensures adherence to global standards such as USFDA, EU GMP, and WHO guidelines.

• Product Quality & Safety
– Reduces contamination risks for sensitive products.

• Operational Efficiency
– Helps maintain consistency and prevents costly recalls.

• Customer Trust
– Demonstrates commitment to maintaining high cleanliness standards.

Conclusion:-

Understanding ISO 14644 cleanroom classifications is essential for ensuring a contamination-free environment in critical industries. Whether you require an ISO Class 1 cleanroom for nanotechnology or an ISO Class 5, 6, 7, or 8 for medical device manufacturing, compliance with these standards guarantees safety, efficiency, and regulatory approval.