MCQ about Ampoule and Vial washing machine & Depyrogenation tunnel October 4, 2023September 7, 2023 by Flair Pharma Results HD Quiz powered by harmonic design Table of Contents Toggle Results#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? #1. What is the primary purpose of an ampoule and vial washing machine in an injectable manufacturing plant? a. To sterilize containers a. To sterilize containers b. To wash the containers, external & internal b. To wash the containers, external & internal c. To label containers c. To label containers d. To seal containers d. To seal containers #2. Which of the following contaminants is primarily removed during the washing process in these machines? a. Microorganisms a. Microorganisms b. Particulate matter b. Particulate matter c. Endotoxins c. Endotoxins d. Chemical impurities d. Chemical impurities #3. Which cleaning method is commonly used in ampoule and vial washing machines to ensure thorough cleaning of the containers? a. High-pressure steam cleaning a. High-pressure steam cleaning b. Ultrasonic cleaning b. Ultrasonic cleaning c. Manual scrubbing c. Manual scrubbing d. Air blowing d. Air blowing #4. What is the typical water temperature range used in ampoule and vial washing machines during the cleaning process? a. 20-30°C a. 20-30°C b. 40-50°C b. 40-50°C c. 80-90°C c. 80-90°C d. 121-134°C d. 121-134°C #5. What is the recommended frequency for the validation and re-qualification of ampoule and vial washing machines in pharmaceutical manufacturing? a. Every 5 years a. Every 5 years b. Annually b. Annually c. Monthly c. Monthly d. Before each batch d. Before each batch #6. What is the primary purpose of the air blowing step in the washing process? a. To remove excess water a. To remove excess water b. To sterilize the containers b. To sterilize the containers c. To dry the containers c. To dry the containers d. To inspect the containers d. To inspect the containers #7. What is the typical acceptable limit for particles remaining on the container after washing, as per regulatory standards? a. 100 particles a. 100 particles b. 500 particles b. 500 particles c. 1,000 particles c. 1,000 particles d. 10,000 particles d. 10,000 particles #8. In a typical ampoule and vial washing process, what is the order of the steps following pre-rinsing? a. Drying, ultrasonic cleaning, final rinse a. Drying, ultrasonic cleaning, final rinse b. Ultrasonic cleaning, final rinse, drying b. Ultrasonic cleaning, final rinse, drying c. Final rinse, ultrasonic cleaning, drying c. Final rinse, ultrasonic cleaning, drying d. Drying, final rinse, ultrasonic cleaning d. Drying, final rinse, ultrasonic cleaning #9. What is the primary purpose of an ampoule and vial depyrogenation tunnel in an injectable manufacturing plant? a. To sterilize containers a. To sterilize containers b. To label containers b. To label containers c. To remove endotoxins c. To remove endotoxins d. To fill containers with the drug product d. To fill containers with the drug product #10. Which of the following contaminants is primarily targeted and removed during the depyrogenation process? a. Microorganisms a. Microorganisms b. Particulate matter b. Particulate matter c. Endotoxins c. Endotoxins d. Chemical impurities d. Chemical impurities #11. What is the primary method used in depyrogenation tunnels to achieve the removal of endotoxins from containers? a. Steam sterilization a. Steam sterilization b. Dry heat b. Dry heat c. Ultraviolet (UV) light c. Ultraviolet (UV) light d. Chemical disinfection d. Chemical disinfection #12. What is the typical temperature range for dry heat depyrogenation in tunnels? a. 50-60°C a. 50-60°C b. 100-150°C b. 100-150°C c. 250-350°C c. 250-350°C d. 500-550°C d. 500-550°C #13. What is the recommended frequency for the validation and re-qualification of depyrogenation tunnels in pharmaceutical manufacturing? a. Every 5 years a. Every 5 years b. Annually b. Annually c. Monthly c. Monthly d. Before each batch d. Before each batch #14. What is the typical acceptable limit for endotoxin levels on containers after depyrogenation, as per regulatory standards? a. 10 EU/mL a. 10 EU/mL b. 100 EU/mL b. 100 EU/mL c. 1,000 EU/mL c. 1,000 EU/mL d. 10,000 EU/mL d. 10,000 EU/mL #15. Which of the following is a common challenge associated with depyrogenation tunnels? a. Excessive cooling a. Excessive cooling b. Insufficient sterilization b. Insufficient sterilization c. Glass breakage c. Glass breakage d. Overheating d. Overheating #16. What is the primary function of the HEPA (High-Efficiency Particulate Air) filters in depyrogenation tunnels? a. To maintain temperature a. To maintain temperature b. To remove endotoxins b. To remove endotoxins c. To label containers c. To label containers d. To load containers d. To load containers Finish
