What are the requirements for an ante area located adjacent to a buffer area?

The correct choice is that the ante area must maintain an ISO Class 8 certification. In the context of sterile compounding, different areas within a pharmacy are classified according to ISO standards, which define the allowable levels of airborne particulate contamination.

The ante area serves as a transition space that helps prepare staff and materials before entering the more critical environment of the buffer area, where sterile products are actually compounded. An ISO Class 8 environment allows for a moderate level of contamination control, which is sufficient for the ante area, as it is not directly involved in the compounding process.

Maintaining this standard is critical in minimizing contamination risks as materials move from the ante area to the buffer area, which is expected to be at a higher classification (ISO Class 7 or 5, depending on specific procedures). The regulation of airflow and filtration within the ante area aligns with the overall goal of maintaining sterility in compounded products, ensuring patient safety while allowing the area to function effectively as a preparatory space.