What is the minimum ISO class required for the buffer area of the SEC?

The minimum ISO class required for the buffer area of the sterile compounding area is ISO class 7. This classification is crucial as it helps to maintain the cleanliness and sterility of the environment in which compounded sterile products are prepared. An ISO class 7 environment allows for a controlled level of airborne particulate contamination, which is essential in preventing contamination of sterile products.

The buffer area provides a space where the actual compounding takes place, and it is designed to minimize exposure to microorganisms and other contaminants to ensure patient safety. An ISO class 7 requirement ensures that there is a low maximum allowable count of particles, which aligns with the strict regulations needed for sterile preparation areas.

While lower ISO classifications such as ISO class 8 may provide adequate conditions for certain less sterile operations, they do not meet the higher standards required for sterile compounding, which necessitates the stricter ISO class 7 standard.