What is the ISO Class 5 particle limit for sterile compounding?

ISO Class 5 is a classification for cleanrooms and controlled environments in which sterile compounding occurs. The standards set by the International Organization for Standardization (ISO) define the maximum allowable particle count for a given size in a specific airspace volume.

For ISO Class 5, the limit is 3,520 particles that are 0.5 micron or larger, measured in a volume of 1 cubic meter of air. This standard is crucial as it ensures that the environment is sufficiently clean to minimize the risk of contamination during the preparation of sterile products. Maintaining a low particle count is essential for the safety and efficacy of compounded sterile preparations.

The significance of adhering to this particle limit is foundational in preventing infections and ensuring patient safety, especially in settings where immunocompromised patients are treated. Understanding these standards helps CSPT professionals maintain compliance and uphold the highest levels of safety in pharmaceutical practices.