What is the beyond-use date (BUD) for opened or needle-punctured single-dose containers in ISO 5 air?

In sterile compounding, the beyond-use date (BUD) is a critical concept that ensures the safety and efficacy of compounded preparations. For opened or needle-punctured single-dose containers in an ISO Class 5 environment, the BUD is set at 6 hours. This timeframe is established based on sterility considerations; once a single-dose container is punctured, it may become susceptible to contaminants from the environment, and thus has a limited period during which it can be utilized safely.

The selection of a 6-hour BUD reflects the balance between safe use and the risk of microbial growth once the integrity of the container is compromised. This short period emphasizes the importance of maintaining stringent aseptic techniques and the necessity of using these preparations promptly after opening to avoid compromising patient safety. Other BUDs mentioned in the choices do not align with the established guidelines for single-dose containers in ISO 5 conditions.