What is the significance of the particle size specified in ISO classifications?

The significance of the particle size specified in ISO classifications is essential for various aspects of cleanroom environments. Particle size directly influences the design and operation of cleanroom facilities because different classes of cleanrooms are defined by the maximum allowable levels of particulate contamination. A cleanroom designed for a specific ISO classification must incorporate appropriate air filtration systems, material handling procedures, and operational protocols to maintain the required level of cleanliness.

For instance, lower ISO classification numbers correlate with stricter cleanliness levels, meaning that the design must effectively mitigate the presence of tiny particles, which can compromise the purity of products or processes within that environment. This necessitates specific designs for ventilation, airlocks, gowning areas, and other features aimed at controlling the introduction and retention of particles. Therefore, particle size and corresponding ISO classifications are crucial determinants in ensuring that cleanroom environments meet the necessary standards for quality and safety across various industries, especially in pharmaceuticals and biotechnology.