What is ISO 14644-1:2016?

ISO 14644-1:2016 is an international standard that specifies the classification of air cleanliness in controlled environments, such as cleanrooms and associated controlled environments. It provides guidelines for the design, construction, and operation of these environments to minimize airborne particles and other contaminants. This standard is highly important in various industries, including pharmaceuticals, medical devices, biotechnology, and electronics manufacturing.

The Purpose of ISO 14644-1:2016

The main purpose of ISO 14644-1:2016 is to define the cleanliness level required for different classes of cleanrooms. Cleanrooms are used when air quality is critical for the product or process being conducted within them. The standard classifies the number of airborne particles per cubic meter (particles/m³) based on particle size. It also establishes the maximum allowable concentration limits for particulate contamination in each specified class.

The Classification System

ISO 14644-1:2016 defines the classification system using two numbers that represent particle size and concentration. The particle size is indicated by a letter followed by a numeric value, such as Class ISO 5 or Class ISO 8. The concentration is represented by a numeric value indicating the number of particles larger than the specified size per cubic meter of air.

The standard provides tables that specify the maximum permissible levels of particles for each class. For example, Class ISO 5 allows a maximum particle concentration of 3520 particles/m³ at 0.1 μm size, while Class ISO 8 allows a maximum concentration of 3,520,000 particles/m³ at the same size.

Benefits of Implementing ISO 14644-1:2016

Implementing ISO 14644-1:2016 offers several benefits, including:

Ensuring product quality and reliability by reducing contaminants that could affect the manufacturing process.

Improving worker safety by minimizing exposure to hazardous particles or substances.

Facilitating compliance with regulatory requirements in industries where cleanrooms are essential.

Enhancing customer satisfaction by meeting or exceeding industry cleanliness standards.