What is the minimum ISO classification necessary for a buffer room?

The minimum ISO classification for a buffer room is ISO Class 7. This classification is essential because buffer rooms are critical environments in sterile compounding, where sterile preparations are made. An ISO Class 7 environment allows for a limited number of particles per cubic meter, which helps ensure that the risk of contamination during the compounding process is minimized.

In the context of sterile compounding, a buffer room must maintain cleanliness to protect sterile products from airborne contaminants. The requirements for ISO Class 7 include a maximum allowable particle count in the air, which helps create a controlled environment where compounding staff can work safely and effectively.

This classification is different from other classes, which may allow for a higher level of particles and thus a greater risk for contamination. For instance, an ISO Class 8 environment allows for a greater number of particles than Class 7, which would not provide the same level of assurance needed for sterile compounding activities. Therefore, ISO Class 7 is the minimum necessary standard for maintaining the integrity of the sterile products handled within a buffer room.