ISO 14644-1: Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness by Particle Concentration

Overview and Purpose

ISO 14644-1 establishes a classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles. This standard is fundamental for industries where the particulate purity of the air is critical to the manufacturing process, product quality, or research integrity. It applies to spaces such as semiconductor manufacturing facilities, pharmaceutical compounding areas, and biotech research labs.

How the Classification Works

1. Particle Concentration Measurement: The standard specifies the methodology for measuring the concentration of airborne particles of different sizes. Measurements are typically conducted using airborne particle counters that can detect and count particles of various diameters.
2. Cleanroom Classification: Based on the particle concentration data, cleanrooms are classified into different levels of cleanliness. The classification ranges from ISO Class 1, the cleanest, to ISO Class 9, based on the allowable number of particles (of specified sizes) per cubic meter of air.
3. Testing and Monitoring: ISO 14644-1 also outlines the requirements for testing and ongoing monitoring of cleanroom environments to ensure they maintain the specified air cleanliness class. This includes the selection of sampling locations, testing frequencies, and the documentation of test results.

Purpose of the Standard

• Standardization of Cleanliness Levels: Provides a standardized and internationally recognized system for classifying the cleanliness of air in controlled environments, facilitating communication and compliance across industries.
• Quality Assurance and Control: Ensures that products susceptible to contamination by airborne particles are manufactured, processed, or packaged in an environment with appropriate air cleanliness levels.
• Health and Safety: In some settings, such as pharmaceutical compounding, maintaining specific air cleanliness levels is critical for ensuring the safety and efficacy of products.