#1. What is the primary purpose of an ampoule and vial washing machine in an injectable manufacturing plant?
#2. Which of the following contaminants is primarily removed during the washing process in these machines?
#3. Which cleaning method is commonly used in ampoule and vial washing machines to ensure thorough cleaning of the containers?
#4. What is the typical water temperature range used in ampoule and vial washing machines during the cleaning process?
#5. What is the recommended frequency for the validation and re-qualification of ampoule and vial washing machines in pharmaceutical manufacturing?
#6. What is the primary purpose of the air blowing step in the washing process?
#7. What is the typical acceptable limit for particles remaining on the container after washing, as per regulatory standards?
#8. In a typical ampoule and vial washing process, what is the order of the steps following pre-rinsing?
#9. What is the primary purpose of an ampoule and vial depyrogenation tunnel in an injectable manufacturing plant?
#10. Which of the following contaminants is primarily targeted and removed during the depyrogenation process?
#11. What is the primary method used in depyrogenation tunnels to achieve the removal of endotoxins from containers?
#12. What is the typical temperature range for dry heat depyrogenation in tunnels?
#13. What is the recommended frequency for the validation and re-qualification of depyrogenation tunnels in pharmaceutical manufacturing?
#14. What is the typical acceptable limit for endotoxin levels on containers after depyrogenation, as per regulatory standards?
#15. Which of the following is a common challenge associated with depyrogenation tunnels?
#16. What is the primary function of the HEPA (High-Efficiency Particulate Air) filters in depyrogenation tunnels?
