For opened single-dose containers maintained in air quality inferior to ISO class 5, what is the maximum time for use after needle puncture?

After a needle puncture, opened single-dose containers must be utilized within a maximum of one hour if they are stored in air quality conditions that are inferior to ISO class 5. This guideline is established to minimize the risk of microbial contamination, which increases over time in environments that do not maintain strict sterile conditions.

Single-dose containers are typically intended for immediate use once opened. However, when compromised by needle puncture, they may become susceptible to contamination if not used swiftly. Limiting the time frame to one hour balances the need for safety while allowing for practical use by healthcare practitioners, ensuring both efficacy and patient safety in medication administration.

The other time frames suggested, such as 30 minutes, 6 hours, and 12 hours, extend beyond the defined safety limit and do not align with the established guidelines for maintaining sterility and minimizing contamination risk in inferior air quality settings.