What is the recommended action level for CFU in ISO 5 air sampling?

The recommended action level for colony-forming units (CFU) in ISO 5 air sampling is greater than 1 CFU. This threshold is especially critical in sterile compounding environments, where maintaining air quality is essential to ensure the safety and efficacy of compounded sterile preparations.

An action level of greater than 1 CFU indicates a potential breach in the aseptic technique or air quality standards, prompting immediate investigation and corrective measures. This is important because even a small number of CFUs can lead to contamination of sterile products, posing a risk to patient safety.

Monitoring CFU levels in ISO 5 environments helps ensure compliance with regulatory standards and facilitates the maintenance of a controlled environment free from microbial contamination. Keeping track of CFU counts and understanding these action levels is necessary for sterile compounding practitioners to uphold the highest standards of practice.