What is the storage requirement for opened single-dose containers maintained in ISO class 5?

Opened single-dose containers maintained in ISO class 5 are required to be used within 6 hours to ensure safety and sterility. This guideline is in place because once a single-dose container has been opened, the manufacturer can no longer guarantee the sterility of the contents, which could lead to contamination. Additionally, the shorter time frame is meant to mitigate the risk of microbial growth that could compromise patient safety.

In the context of compounding and medication dispensing, keeping opened single-dose containers out of the controlled environment of ISO class 5 for too long can increase the risk of contamination. Therefore, the 6-hour limit helps maintain the integrity of the medication and aligns with established standards for aseptic processing in healthcare settings.