What equipment is needed to prepare medium-risk sterile preparations?

To prepare medium-risk sterile preparations, the essential equipment needed is an ISO 5 or better Biological Safety Cabinet (BSC), Compounding Aseptic Isolator (CAI), or Laminar Air Flow (LAF) hood. This equipment is crucial because it provides the necessary sterile environment to minimize the risk of contamination during the compounding process.

ISO 5 environments are designed to have a maximum allowable particle count, ensuring that the air quality is sufficiently sterile for handling materials that will be introduced directly into the bloodstream or other sterile body areas. The use of a BSC, CAI, or LAF hood provides both protection for the compounded preparations and the personnel working with potentially hazardous materials.

In contrast, a cleanroom environment classified as ISO 7 is generally too permissive for the sterile compounding process, as it does not maintain stringent sterility levels required for medium-risk sterile preparations. The absence of airflow restrictions in connection to ISO 7 cleanrooms further undermines the sterile conditions necessary for the preparation. Similarly, ISO 6 equipment with positive airflow, while an improvement over lower classifications, does not meet the sterility standards required for such preparations, thus making them insufficient for the risk level indicated.

Overall, the use of ISO