What does a Class 100 Environment (ISO Class 5) refer to?

A Class 100 environment, also known as ISO Class 5, refers to a specific level of air cleanliness in controlled environments, particularly in cleanrooms and sterile compounding areas. In this context, the classification means that the environment has less than 100 particles sized 0.5 microns or larger per cubic meter of air.

This standard is essential for ensuring the safety and effectiveness of compounded sterile preparations, as lower particle counts reduce the risk of contamination. Such rigorous air quality standards are critical in pharmaceutical settings to protect both the products being made and the patients who will ultimately receive them. The classification dictates operational practices and equipment used in facilities to maintain these cleanliness standards.

The other options specify different limits for particle concentrations of sizes and counts that do not align with the definitions established for ISO classifications. A Class 100 environment is particularly stringent, requiring a specific threshold that is commonly recognized in the industry.