ISO Classification of Clean Rooms: Complete Guide

What is ISO 14644 Classification?

ISO 14644-1 establishes the classification of air cleanliness in clean rooms and controlled zones. It defines nine classes (ISO 1 to ISO 9) based on the maximum particle concentration per cubic meter of air.

Most Used ISO Classes in Industry

ISO 5 (Class 100) - **Allowed particles:** 3,520 particles ≥0.5μm per m³ - **Typical use:** Operating rooms, semiconductor manufacturing, sterile medical device assembly - **Airflow:** Unidirectional laminar - **Air changes:** 240-600 per hour

ISO 7 (Class 10,000) - **Allowed particles:** 352,000 particles ≥0.5μm per m³ - **Typical use:** Pharmaceutical production, research laboratories, medical device manufacturing - **Airflow:** Controlled turbulent - **Air changes:** 30-60 per hour

ISO 8 (Class 100,000) - **Allowed particles:** 3,520,000 particles ≥0.5μm per m³ - **Typical use:** Quality control laboratories, packaging areas, preparation zones - **Airflow:** Turbulent - **Air changes:** 10-25 per hour

How to Choose the Right Classification?

Classification depends on three main factors:

1. Applicable regulation: COFEPRIS, FDA, ISO 13485 or industry-specific standards determine the minimum required classification.
2. Product or process: The sensitivity level of your product to particle contamination.
3. Operating cost: Each stricter ISO level significantly increases construction and operating costs.

The Sinergix Approach

At Sinergix, classification is determined during the initial technical visit. Adrián evaluates your regulatory requirements, manufacturing process and site conditions before recommending a classification. We don't quote blindly — each clean room is specifically designed for your operation.