Question

*opened or needle-punctured single dose* containers of sterile products shall be used within ____ if opened in *worse than* ISO Class ____ air quality and remaining contents must be discarded.

Answer 1

Opened or needle-punctured single-dose containers need to be used within one hour in worse than ISO Class 5 air quality, with remaining contents discarded afterward.

Step-by-step explanation:

According to USP General Chapter <797>, opened or needle-punctured single dose containers of sterile products shall be used within 1 hour if opened in worse than ISO Class 5 air quality and remaining contents must be discarded.

The question relates to the use and storage of sterile products in medical settings, specifically single-dose containers. The USP guidelines state that opened or needle-punctured single-dose containers should be used within one hour if opened in air quality worse than ISO Class 5. Any remaining contents must be discarded after this period to avoid risk of contamination and ensure patient safety.