How many particles are allowed in ISO Class 8 for sterile compounding?

ISO Class 8 is a classification that delineates the maximum allowable levels of particulate contamination in a controlled environment for sterile compounding. Specifically, for ISO Class 8, the standard allows for a maximum of 3,520,000 particles that are 0.5 micron or larger per cubic meter of air.

Understanding this standard is critical for ensuring that sterile preparations are made in an environment that minimizes contamination risks. This concentration level is established to help protect patient safety by maintaining a clean sterile environment where compounding takes place.

Recognizing the importance of maintaining proper ISO classifications helps technicians assess whether their compounding areas meet the required standards for sterile preparations, thus significantly contributing to quality control practices in pharmacy settings.