What type of air quality does a Clean Room (Buffer Room) need to achieve?

A Clean Room, specifically the Buffer Room where sterile compounding takes place, must achieve an air quality of ISO Class 7. This classification ensures that the environment is adequately controlled to minimize the risk of contamination during the compounding of sterile preparations. An ISO Class 7 cleanroom allows for a maximum of 352,000 particles per cubic meter that are 0.5 micrometers in size, which is critical for achieving the necessary aseptic conditions required for pharmaceutical manufacturing, particularly for preparing sterile products.

In a Buffer Room, the standards set by ISO Class 7 are vital because these spaces are intended to be the interface between the uncontrolled environment and where the compounding occurs. The stringent air quality requirements help protect the integrity of the compounded sterile preparations by limiting airborne particles that could lead to contamination. The setting also typically uses High Efficiency Particulate Air (HEPA) filtration and strict cleaning practices to maintain the specified air quality.

Higher classifications than ISO Class 7, such as ISO Class 5, provide even cleaner environments but are generally designated for the primary compounding area itself—where the actual aseptic manipulation occurs—rather than the buffer room. Lower classifications, like ISO Class 8 or Class 9, do not provide sufficient