Where can a CAI be placed according to ISO Class standards?

The correct response indicates that a Controlled Area for Intermediates (CAI) must be placed in environments classified as ISO Class 7 or higher. ISO Class standards are designed to ensure that environments maintain specific levels of particulate contamination, which is crucial for activities involving sterile compounding and the production of pharmaceuticals.

ISO Class 7 environments allow for a controlled number of airborne particulate matter, which is essential for the proper functioning of a CAI. These areas ensure that the quality and integrity of compounded sterile preparations are maintained by minimizing contamination risks. Furthermore, placing a CAI in such environments aligns with regulations and best practices for sterility assurance.

The other options suggest placements in environments that do not meet the necessary cleanliness and air quality standards required for the safe operation of a CAI. For instance, positioning it adjacent to a positive pressure room or within any area may expose the CAI to higher levels of contaminants, thus compromising the sterility of the preparations. Limiting placement to ISO Class 5 environments would be overly restrictive and may not be feasible for all operations that utilize a CAI, as not all areas can maintain that high level of cleanliness.