Which area classification is acceptable for Low Risk CSPs with BUDs less than 12 hours?

For Low Risk Compounded Sterile Preparations (CSPs) with Beyond Use Dates (BUDs) of less than 12 hours, the appropriate setting is one that ensures a controlled environment to maintain sterility during the compounding process. In this context, using an ISO 5 environment is essential, as it provides a particulate matter limit that helps to minimize contamination risks.

A Compounding Aseptic Intravenous (CAI) in a SCA (Segregated Compounding Area) is designed specifically for this type of operation. The SCA allows for the compounding of CSPs with shorter BUDs without the need for extensive cleanroom certification processes that are required in a more rigorously controlled buffer area. This setting provides sufficient cleanliness while accommodating the shorter shelf life of Low Risk CSPs.

In contrast, the other options present different scenarios that aren't suitable for Low Risk CSPs with short BUDs. For instance, an ISO 7 buffer area requires more stringent controls that often conflict with the immediate use criteria and is generally intended for higher-risk preparations or preparations that require longer BUDs. An ISO 6 clean area may not offer the same level of cleanliness as ISO 5, making it less ideal for