What is the ISO Class 7 particle limit for sterile compounding?

The ISO Class 7 environment for sterile compounding is defined by specific standards for particle contamination. In this classification system, an ISO Class 7 area can have a maximum of 352,000 particles that are 0.5 micron or larger per cubic meter of air. This standard is critical for ensuring the sterility of compounded sterile preparations since particulate contamination can significantly impact patient safety and the efficacy of the compounded products.

The significance of the particle limit directly ties into the overall cleanliness and control measures required in the compounding environment. Maintaining such stringent standards is essential to prevent microbial contamination, which is particularly vital in settings where medications are prepared for injection or other invasive methods.

Understanding these limits helps ensure that Compounded Sterile Preparation Technicians are aware of the necessary conditions to maintain an effective sterile compounding environment, emphasizing the importance of strict adherence to these classifications in practice.