MCQ about the Holding & Aseptic Filtrationsin the Sterile Product Manufecturing August 22, 2023 by Flair Pharma Results HD Quiz powered by harmonic design Table of Contents Toggle Results#1. Which type of manufacturing vessel is specifically designed for the aseptic storage of sterile products before packaging? #2. What is the primary function of a "Buffer Vessel" in sterile drug manufacturing? #3. What is the purpose of a "Filtration Vessel" in sterile drug manufacturing? #4. What is the purpose of "Vessel Cleaning" in sterile drug manufacturing? #5. What is the role of the agitator in a holding sterile vessel? #6. What is the purpose of "Riboflavin Testing" of a holding sterile vessel? #7. How does Riboflavin Testing work in the context of a holding sterile vessel? #8. What is the purpose of CIP (Clean-in-Place) in the context of holding sterile vessels? #9. What is the purpose of SIP (Steam-in-Place) in the context of holding sterile vessels? #10. What is the recommended duration of SIP (Steam-in-Place) for sterilizing a holding sterile vessel? #11. What is the purpose of "Vessel Passivation" in the context of holding sterile vessels? #12. How does SIP (Steam-in-Place) work in a holding sterile vessel? #13. What is the purpose of "Hold Time" in a holding sterile vessel after SIP (Steam-in-Place)? #14. What is the purpose of "Aseptic Transfer" in the context of holding sterile vessels? #15. Which parameter is critical to monitor during SIP (Steam-in-Place) to ensure proper sterilization of the holding sterile vessel? #16. What is the purpose of "Drying Phase" after SIP (Steam-in-Place)? #17. Which of the following is a critical parameter to monitor during Riboflavin Testing to ensure accurate results? #18. What is the purpose of "Post-SIP Cooling" after Steam-in-Place? #1. Which type of manufacturing vessel is specifically designed for the aseptic storage of sterile products before packaging? a) Fermentation vessel a) Fermentation vessel b) Filtration vessel b) Filtration vessel c) Buffer vessel c) Buffer vessel d) Storage vessel d) Storage vessel #2. What is the primary function of a "Buffer Vessel" in sterile drug manufacturing? a) To store raw materials a) To store raw materials b) To maintain a controlled environment b) To maintain a controlled environment c) To facilitate heat transfer c) To facilitate heat transfer d) To provide a space for intermediate storage d) To provide a space for intermediate storage #3. What is the purpose of a "Filtration Vessel" in sterile drug manufacturing? a) To store raw materials a) To store raw materials b) To facilitate temperature control during reactions b) To facilitate temperature control during reactions c) To perform filtration and separation processes c) To perform filtration and separation processes d) To provide aseptic conditions d) To provide aseptic conditions #4. What is the purpose of "Vessel Cleaning" in sterile drug manufacturing? a) To monitor the flow rate of raw materials a) To monitor the flow rate of raw materials b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To ensure proper lighting in the manufacturing area c) To ensure proper lighting in the manufacturing area d) To remove residue and contaminants after each use d) To remove residue and contaminants after each use #5. What is the role of the agitator in a holding sterile vessel? a) To measure the pH of the solution a) To measure the pH of the solution b) To prevent overpressure b) To prevent overpressure c) To provide lighting in the vessel c) To provide lighting in the vessel d) To maintain homogeneity of the solution d) To maintain homogeneity of the solution #6. What is the purpose of "Riboflavin Testing" of a holding sterile vessel? a) To measure the color of the product a) To measure the color of the product b) To assess the viscosity of the solution b) To assess the viscosity of the solution c) To evaluate the integrity & CIP of vessel c) To evaluate the integrity & CIP of vessel d) To monitor the temperature and humidity inside the vessel d) To monitor the temperature and humidity inside the vessel #7. How does Riboflavin Testing work in the context of a holding sterile vessel? a) Riboflavin is used to flavor the product inside the vessel a) Riboflavin is used to flavor the product inside the vessel b) Riboflavin is added to the solution, and UV light is used to detect leaks b) Riboflavin is added to the solution, and UV light is used to detect leaks c) Riboflavin is used to adjust the pH of the solution c) Riboflavin is used to adjust the pH of the solution d) Riboflavin is added to measure the concentration of active ingredient d) Riboflavin is added to measure the concentration of active ingredient #8. What is the purpose of CIP (Clean-in-Place) in the context of holding sterile vessels? a) To monitor the flow rate of raw materials a) To monitor the flow rate of raw materials b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To clean the interior surfaces of the vessel without disassembly c) To clean the interior surfaces of the vessel without disassembly d) To measure the pressure inside the vessel d) To measure the pressure inside the vessel #9. What is the purpose of SIP (Steam-in-Place) in the context of holding sterile vessels? a) To measure the pH of the solution a) To measure the pH of the solution b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To sterilize the interior surfaces of the vessel using steam c) To sterilize the interior surfaces of the vessel using steam d) To adjust the temperature of the vessel contents d) To adjust the temperature of the vessel contents #10. What is the recommended duration of SIP (Steam-in-Place) for sterilizing a holding sterile vessel? a) 5 minutes a) 5 minutes b) 30 minutes b) 30 minutes c) 2 hours c) 2 hours d) 24 hours d) 24 hours #11. What is the purpose of "Vessel Passivation" in the context of holding sterile vessels? a) To test the viscosity of the solution a) To test the viscosity of the solution b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To neutralize and remove contaminants from vessel surfaces c) To neutralize and remove contaminants from vessel surfaces d) To measure the pressure inside the vessel d) To measure the pressure inside the vessel #12. How does SIP (Steam-in-Place) work in a holding sterile vessel? a) Steam is injected into the vessel to maintain temperature a) Steam is injected into the vessel to maintain temperature b) Steam is used to dissolve active ingredients in the solution b) Steam is used to dissolve active ingredients in the solution c) Steam is used to detect leaks using UV light c) Steam is used to detect leaks using UV light d) Steam is injected into the vessel to achieve sterilization d) Steam is injected into the vessel to achieve sterilization #13. What is the purpose of "Hold Time" in a holding sterile vessel after SIP (Steam-in-Place)? a) To monitor the temperature inside the vessel a) To monitor the temperature inside the vessel b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To allow sufficient time for sterilization to occur c) To allow sufficient time for sterilization to occur d) To measure the flow rate of raw materials d) To measure the flow rate of raw materials #14. What is the purpose of "Aseptic Transfer" in the context of holding sterile vessels? a) To assess the color and appearance of the product a) To assess the color and appearance of the product b) To transfer sterile solutions into the vessel without contamination b) To transfer sterile solutions into the vessel without contamination c) To adjust the temperature of the vessel contents c) To adjust the temperature of the vessel contents d) To neutralize and remove contaminants from vessel surfaces d) To neutralize and remove contaminants from vessel surfaces #15. Which parameter is critical to monitor during SIP (Steam-in-Place) to ensure proper sterilization of the holding sterile vessel? a) Ambient light intensity a) Ambient light intensity b) Color of the product b) Color of the product c) Steam temperature and pressure c) Steam temperature and pressure d) Vessel volume d) Vessel volume #16. What is the purpose of "Drying Phase" after SIP (Steam-in-Place)? a) To test the viscosity of the solution a) To test the viscosity of the solution b) To assess the color and appearance of the product b) To assess the color and appearance of the product c) To remove excess moisture from the vessel surfaces c) To remove excess moisture from the vessel surfaces d) To adjust the pH of the solution d) To adjust the pH of the solution #17. Which of the following is a critical parameter to monitor during Riboflavin Testing to ensure accurate results? a) Ambient humidity a) Ambient humidity b) UV light intensity b) UV light intensity c) Ambient temperature c) Ambient temperature d) Color of the product d) Color of the product #18. What is the purpose of "Post-SIP Cooling" after Steam-in-Place? a) To assess the color and appearance of the product a) To assess the color and appearance of the product b) To cool down the vessel before opening b) To cool down the vessel before opening c) To measure the pressure inside the vessel c) To measure the pressure inside the vessel d) To neutralize residual steam d) To neutralize residual steam Finish
