What does a cleanroom suite consist of for sterile compounding?

A cleanroom suite for sterile compounding is specifically designed to provide a controlled environment to minimize the risks of contamination during the preparation of compounded sterile preparations (CSPs). It is crucial to maintain the highest level of cleanliness in this environment to ensure patient safety.

The correct understanding of a cleanroom suite includes both an ante-room and a buffer room. The ante-room is the area where personnel can change into clean attire and perform tasks such as hand hygiene and equipment decontamination. The buffer room, also known as the cleanroom, is the area where the actual sterile compounding occurs, and it must maintain specific standards of air quality and cleanliness.

A designated area for category 1 CSPs only does not encompass the complete requirements and infrastructure needed for a cleanroom suite. Category 1 CSPs are those that are prepared with less stringent conditions than more complex category 2 CSPs, which require full sterile compounding capabilities in a cleanroom suite. Thus, the comprehensive setup includes both the ante-room and the buffer room to create a controlled environment conducive to safe and effective compounding practices.