#1. What is the primary goal of aseptic filling in pharmaceutical manufacturing?
#2. Which type of pharmaceutical product is typically filled using aseptic techniques?
#3. Which of the following is NOT a common container for aseptic filling of injectable products?
#4. What is the purpose of sterilizing vials, ampoules, and other containers in aseptic filling?
#5. Which of the following is an essential component of a cleanroom environment for aseptic filling?
#6. Which technology is commonly used for the sterilization of aseptic filling equipment?
#7. What is lyophilization in the context of injectable manufacturing?
#8. Which of the following is an example of an excipient used in injectable manufacturing?
#9. During aseptic filling, what is the primary purpose of continuous monitoring and validation?
#10. What is the most common method for sealing vials during aseptic filling?
#11. What is the primary advantage of using pre-filled syringes in injectable manufacturing?
#12. Which of the following is not a critical parameter monitored during aseptic filling?
#13. What is the purpose of depyrogenation in the preparation of containers for aseptic filling?
#14. Which material is commonly used for the construction of ampoules and vials for injectable products?
#15. What is the recommended temperature range for sterilizing vials and ampoules using autoclaving?
#16. In a typical ISO 5 cleanroom for aseptic filling, what is the maximum allowable number of particles per cubic meter of air (0.5 μm and larger)?
#17. What is the common maximum allowable microbial contamination level for sterile water for injection (WFI)?
#18. What is the typical acceptable rate of microbial contamination for aseptic filling equipment surfaces (per square centimeter)?
#19. How often should environmental monitoring be performed in aseptic filling cleanrooms, as recommended by regulatory guidelines?
#20. What is the approximate maximum allowable particle size (in micrometers) in an injectable product for it to be considered sterile?
