Barrier Technologies in Pharma EUGMP- Annex-1
Questions 1. What is the primary purpose of isolators or RABS?
A. To increase production speed
B. To provide separation between Grade A and surrounding environment
C. To reduce staffing needs
D. To improve HVAC efficiency
Answer: B
Questions 2. What should be minimized when using isolators or RABS?
A. Machine noise
B. Entry/removal hazards
C. Operator training
D. Cleaning frequency
Answer: B
Questions 3. Transfer technologies used with isolators/RABS should be:
A. Low-cost
B. High capability or validated
C. Optional
D. Manual
Answer: B
Questions 4. What must be ensured in the critical zone?
A. Grade B conditions
B. Proper lighting
C. Appropriate conditions to protect exposed product
D. Operator comfort
Answer: C
Questions 5. Open isolators must ensure:
A. Grade C conditions
B. Grade A with first air protection and unidirectional airflow
C. Grade B conditions
D. Turbulent airflow
Answer: B
Questions 6. Closed isolators must ensure:
A. Partial Grade C conditions
B. Grade A conditions with adequate product protection
C. Only HEPA filtration
D. Natural airflow
Answer: B
Questions 7. In closed isolators, turbulent airflow is acceptable if:
A. It reduces costs
B. It does not increase contamination risk
C. The operation is simple
D. It comes from HVAC
Answer: B
Questions 8. Negative pressure isolators are used when:
A. Energy saving is required
B. Containment is essential
C. Products are low risk
D. Grade B is sufficient
Answer: B
Questions 9. What must RABS design ensure?
A. Grade C environment
B. Unidirectional airflow with first air protection
C. Negative pressure
D. Manual cleaning
Answer: B
Questions 10. RABS must maintain:
A. Positive airflow from critical zone to background
B. Negative airflow
C. Zero airflow
D. Recirculating airflow
Answer: A
Questions 11. Background for open isolators is generally:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Questions 12. Background for closed isolators is generally:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Questions 13. Background environment selection must be justified in:
A. HVAC manual
B. Equipment logbook
C. CCS
D. SOP
Answer: C
Questions 14. Which is NOT a factor in CCS risk assessment for isolators?
A. Bio-decontamination program
B. Glove manipulations
C. Operator salary
D. Automation level
Answer: C
Premises – Cleanrooms and Sterile Manufacturing
Questions 15. Airflow studies for open isolators must show:
A. Cooling efficiency
B. Absence of air ingress
C. Operator comfort
D. Pressure differences
Answer: B
Questions 16. RABS background environment minimum grade:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: B
Questions 17. Airflow studies for RABS must include:
A. Lighting tests
B. Door opening interventions
C. Noise tests
D. Cleaning validation
Answer: B
Questions 18. Glove systems must demonstrate:
A. Chemical and mechanical resistance
B. Colour uniformity
C. Low cost
D. Operator comfort
Answer: A
Questions 19. Glove replacement frequency must be defined in:
A. HR policy
B. CCS
C. HVAC SOP
D. Annual report
Answer: B
Questions 20. For isolators, glove leak testing must occur:
A. Monthly only
B. Randomly
C. At defined intervals
D. Once per year
Answer: C
Questions 21. Minimum frequency for isolator glove integrity testing:
A. Once a week
B. Beginning and end of each batch/campaign
C. Only at installation
D. Every 6 months
Answer: B
Questions 22. Glove integrity monitoring includes:
A. Weight measurement
B. Visual inspection
C. Color assessment
D. Sound test
Answer: B
Questions 23. For manual aseptic processing, glove verification frequency may be based on:
A. Shift timing
B. Manufacturing session start/end
C. Operator preference
D. Equipment size
Answer: B
Questions 24. Isolator systems require integrity/leak testing:
A. Only at installation
B. At defined intervals
C. Only during breakdown
D. Not required
Answer: B
Questions 25. Gloves in RABS Grade A must be:
A. Cleaned weekly
B. Sterilized before installation
C. Used repeatedly without cleaning
D. Replaced monthly
Answer: B
Questions 26. RABS gloves exposed to background must be:
A. Sanitized annually
B. Disinfected after each exposure
C. Painted
D. Repaired manually
Answer: B
Questions 27. RABS gloves require integrity testing:
A. Never
B. Only once
C. Periodically
D. Daily
Answer: C
Questions 28. Decontamination methods must be:
A. Arbitrary
B. Defined and controlled
C. Operator-dependent
D. Optional
Answer: B
Questions 29. Cleaning before bio-decontamination is essential because:
A. It increases brightness
B. Residues may inhibit decontamination
C. It reduces noise
D. It prevents airflow
Answer: B
Questions 30. Cleaning & bio-decontamination agents must not:
A. Be purchased locally
B. Impact product adversely
C. Be sterile
D. Have color
Answer: B
Questions 31. Isolator interior bio-decontamination must be:
A. Manual
B. Automated and validated
C. Random
D. Optional
Answer: B
Questions 32. Isolator bio-decontamination must include:
A. A perfume agent
B. A sporicidal agent
C. A coloring agent
D. A detergent
Answer: B
Questions 33. Gloves should be extended with:
A. Tape
B. Strings
C. Fingers separated for agent contact
D. Plastic rings
Answer: C
Questions 34. The bio-decontamination process must render interior surfaces:
A. Dry
B. Free from viable microorganisms
C. Colorless
D. Hot
Answer: B
Questions 35. RABS sporicidal disinfection must be:
A. Validated
B. Random
C. Optional
D. Manual only
Answer: A
Questions 36. RABS sporicidal disinfection must cover:
A. Only visible surfaces
B. All interior surfaces
C. Only glove ports
D. Only doors
Answer: B
Questions 37. RABS internal environment must be suitable for:
A. Storage
B. Aseptic processing
C. Packing
D. Calibration
Answer: B
Questions 38. The CCS is used to:
A. Approve employee salaries
B. Justify classification decisions
C. Approve HVAC suppliers
D. Purchase equipment
Answer: B
Questions 39. First air protection refers to:
A. Air from HVAC
B. Cleanest air reaching product first
C. Warm air
D. Unfiltered air
Answer: B
Questions 40. Critical zone refers to:
A. Storage rooms
B. Product exposure area
C. Packaging area
D. Warehouse
Answer: B
Questions 41. RABS should maintain a pressure that is:
A. Negative
B. Neutral
C. Positive
D. Variable
Answer: C
Questions 42. Turbulent airflow in isolators is acceptable only if:
A. It lowers cost
B. It does not compromise product
C. It increases speed
D. It keeps the area cool
Answer: B
Questions 43. Transfer systems must:
A. Be validated
B. Be manual-only
C. Use plastic only
D. Allow frequent openings
Answer: A
Questions 44. Glove integrity testing is performed because:
A. Gloves may discolor
B. Gloves can develop leaks
C. Gloves are expensive
D. Gloves must be soft
Answer: B
Questions 45. RABS gloves must be disinfected when:
A. Shift ends
B. Exposed to background
C. Weekly
D. Monthly
Answer: B
Questions 46. Residues remaining before bio-decontamination may:
A. Prevent cleaning
B. Inhibit sporicidal action
C. Increase humidity
D. Increase pressure
Answer: B
Questions 47. Suitable sporicidal agents may be in:
A. Powder form
B. Liquid only
C. Gaseous or vaporized form
D. Foam form
Answer: C
Questions 48. Bio-decontamination cycle parameters must be:
A. Optional
B. Defined and controlled
C. Hidden
D. Random
Answer: B
Questions 49. RABS disinfection must make environment:
A. Clean only
B. Suitable for aseptic processing
C. Cold
D. Odor-free
Answer: B
Questions 50. Air ingress in isolators indicates:
A. Proper airflow
B. Containment breach
C. Good pressure
D. Clean area
Answer: B
Questions 51. Which system uses glove ports?
A. HVAC
B. RABS and isolators
C. Packaging machine
D. Autoclave
Answer: B
Questions 52. Integrity testing of isolator systems refers to:
A. Checking temperature
B. Leak testing
C. Disinfection
D. Calibration
Answer: B
Questions 53. RABS background must correspond to minimum:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: B
Questions 54. Loss of glove integrity may:
A. Improve airflow
B. Compromise first air protection
C. Reduce bio-decontamination
D. Improve sterility
Answer: B
Questions 55. Grade A environment is required in:
A. Critical zones of isolators/RABS
B. Warehouse
C. Canteen
D. Utility room
Answer: A
Questions 56. Transfer mechanisms must prevent:
A. Air filtration
B. Contamination
C. HVAC operation
D. Door locking
Answer: B
Questions 57. Bio-decontamination automation ensures:
A. Lower costs
B. Operator-independent control
C. Easier cleaning
D. More noise
Answer: B
Questions 58. Sporicidal disinfection in RABS is performed:
A. Once per year
B. Only if contamination occurs
C. Routinely
D. Never
Answer: C
Questions 59. Automation in isolators reduces risk from:
A. HVAC failures
B. Manual interventions
C. Cleaning agents
D. Pressure loss
Answer: B
Questions 60. Decontamination methods must also prevent:
A. Product discoloration
B. Adverse impact on product
C. Loss of profit
D. Downtime
Answer: B