#1. The primary philosophy behind isolator technology is to:
#2. Which statement best differentiates an isolator from a cleanroom?
#3. In isolator systems, “closed processing” mainly refers to:
#4. The effectiveness of VHP decontamination is MOST influenced by:
#5. Which parameter is NOT directly critical during VHP cycle development?
#6. Biological indicators used in isolator validation usually contain spores of:
#7. During routine operation, a glove tear is observed inside an isolator. What is the MOST appropriate action?
#8. Environmental monitoring inside an isolator typically shows:
#9. An isolator shows repeated failure in decontamination at one corner. What is the most likely root cause?
#10. Pressure inside a sterility assurance isolator for aseptic filling is usually:
#11. Which feature is CRITICAL to prevent cross-contamination in isolators?
#12. HEPA filters in isolators are generally integrity tested:
#13. Regulatory agencies prefer isolators because they:
#14. Which document MOST strongly supports routine isolator operation?
#15. Media fill frequency for isolator-based aseptic processing is generally:
#16. Why are isolator gloves considered the highest contamination risk point?
#17. Which practice BEST extends glove integrity life?
#18. Transfer of materials into isolators is commonly achieved through:
#19. Why is environmental monitoring still required in isolators despite decontamination?
#20. Why is environmental monitoring still required in isolators despite decontamination?
#21. The greatest advantage of isolator technology over RABS is:
