What is the ISO Class 8 Colony Forming Unit Action Level?

The ISO Class 8 Colony Forming Unit Action Level is set at 100 CFU for a specific volume of air. This standard is crucial in the context of sterile compounding environments, as it helps maintain an appropriate level of cleanliness and safety for compounded sterile preparations. When air samples are taken, discovering a level of 100 CFU or more indicates that the environment is not meeting the required cleanliness standards. It prompts a review and corrective action to restore compliance, emphasizing the importance of maintaining stringent environmental controls in compounding areas to minimize the risk of contamination. Understanding these standards plays a significant role in ensuring patient safety and product integrity.