Manufacture of Sterile Preparations
Question 1. Clean areas for sterile product manufacture are classified according to:
A. Equipment cost
B. Required environmental characteristics
C. Number of personnel
D. Type of raw material
Answer: B
Question 2. The purpose of environmental cleanliness classification is to minimize:
A. Energy consumption
B. Packaging cost
C. Particulate or microbial contamination
D. Airflow noise
Answer: C
Question 3. ISO 14644-1 is used for:
A. Lab safety
B. Classification of airborne particles
C. Personnel proficiency
D. Cleaning validation
Answer: B
Question 4. How many clean area grades are distinguished for sterile manufacturing?
A. Two
B. Three
C. Four
D. Five
Answer: C
Question 5. Grade A areas are used for:
A. Storage rooms
B. High-risk operations such as filling
C. Personnel gowning
D. Packaging
Answer: B
Question 6. Grade A conditions are typically achieved using:
A. Turbulent airflow booths
B. Positive pressure suit rooms
C. Unidirectional airflow workstations
D. Gravity ventilation
Answer: C
Question 7. The guidance air velocity at Grade A unidirectional airflow test position is:
A. 0.1–0.2 m/s
B. 0.36–0.54 m/s
C. 1–2 m/s
D. 5–10 m/s
Answer: B
Question 8. The minimum velocity at working level in Grade A should be:
A. 0.1 m/s
B. 0.25 m/s
C. 0.36 m/s
D. 1 m/s
Answer: C
Question 9. Airflow visualization tests in Grade A are used to:
A. Measure humidity
B. Verify unidirectional airflow uniformity
C. Check CO₂ levels
D. Estimate energy use
Answer: B
Question 10. Grade B is the background environment for:
A. Grade D
B. Grade A
C. Grade C
D. All grades
Answer: B
Sterile Pharmaceutical Products WHO GMP
Question 11. Grades C and D are intended for:
A. High-risk aseptic operations
B. Less critical stages where product is not directly exposed
C. Personnel change rooms only
D. Outdoor storage
Answer: B
Question 12. HEPA filters should undergo leak testing every:
A. Month
B. 3 months
C. 6–12 months
D. 5 years
Answer: C
Question 13. The purpose of HEPA leak tests is to ensure:
A. Color uniformity
B. No microbial growth
C. Filter media and seals are free from leaks
D. Correct pressure differential
Answer: C
Question 14. Clean rooms must be classified according to:
A. ISO 9001
B. ISO 14000
C. ISO 14644
D. WHO PQS
Answer: C
Question 15. The “at rest” state means:
A. Room with no air running
B. No equipment installed
C. Completed installation, equipment operating, no personnel
D. Room under construction
Answer: C
Question 16. The “in operation” state means:
A. Only airflow is running
B. Equipment running with personnel present
C. No operations occurring
D. Gowning only
Answer: B
Question 17. For Grade A classification, minimum sample volume per location is:
A. 0.1 m³
B. 0.5 m³
C. 1 m³
D. 10 m³
Answer: C
Question 18. Grade A corresponds to ISO classification:
A. ISO 8
B. ISO 5
C. ISO 4.8
D. ISO 2
Answer: C
Question 19. Grade B (at rest) corresponds to ISO:
A. ISO 5
B. ISO 6
C. ISO 7
D. ISO 8
Answer: A
Question 20. Grade C (at rest) corresponds to ISO:
A. ISO 5
B. ISO 7
C. ISO 8
D. ISO 4
Answer: B
Question 21. Grade D (at rest) corresponds to ISO:
A. ISO 5
B. ISO 7
C. ISO 8
D. ISO 4.8
Answer: C
Question 22. Lower-grade (C and D) sample volume per location should be at least:
A. 0.1 L
B. 1 L
C. 2 L
D. 10 L
Answer: C
Question 23. Particle counters used for classification should have:
A. Very long sample tubes
B. Short sampling tubes for ≥5 μm particles
C. No tubing
D. Multiple pumps
Answer: B
Question 24. Isokinetic sampling heads are used in:
A. Grade D only
B. Turbulent airflow zones
C. Unidirectional airflow systems
D. Storage rooms
Answer: C
Question 25. Particle monitoring in Grade A should occur:
A. Only at batch end
B. Only once per shift
C. For the full duration of critical processing
D. Never during filling
Answer: C
Question 26. Grade B monitoring frequency compared to A is:
A. Higher
B. Same
C. Lower
D. Not required
Answer: C
Question 27. The purpose of alarms in particle monitoring is to detect:
A. Equipment noise
B. Alert limit exceedances
C. Personnel movement
D. Temperature changes
Answer: B
Question 28. Remote sampling tubing must be evaluated for:
A. Color
B. Particle losses
C. Length only
D. Heat resistance
Answer: B
Question 29. Sample sizes during routine monitoring:
A. Must match classification sample volume
B. Need not match classification sample volume
C. Must be doubled
D. Must be 10× larger
Answer: B
Question 30. “Clean-up” or “recovery” period for Grade A/B is approximately:
A. 1 minute
B. 5 minutes
C. 15–20 minutes
D. 1 hour
Answer: C
Question 31. Clean-up tests must demonstrate reduction in particles by a factor of:
A. 2
B. 10
C. 100
D. 1000
Answer: C
Question 32. Environmental monitoring should detect:
A. Only airborne particles
B. Airborne and microbial contamination
C. Only pressure changes
D. Only temperature
Answer: B
Question 33. Microbiological monitoring methods include all EXCEPT:
A. Settle plates
B. Air sampling
C. Surface swabs
D. X-ray scans
Answer: D
Question 34. Monitoring results influence:
A. Personnel salaries
B. Product release decisions
C. HVAC energy usage
D. Manufacturing schedule only
Answer: B
Question 35. Microbial contamination limits are expressed in:
A. mg/mL
B. % contamination
C. CFU
D. ppm
Answer: C
Question 36. Grade A microbial limit for air sample is:
A. <1 CFU/m³
B. <10 CFU/m³
C. <50 CFU/m³
D. Not defined
Answer: A
Question 37. Grade B microbial limit for air sample is:
A. <1
B. 10
C. 100
D. 1000
Answer: B
Question 38. Grade C microbial limit for air sample is:
A. <1
B. 10
C. 100
D. 200
Answer: C
Question 39. Grade D microbial limit for air sample is:
A. <1
B. 10
C. 200
D. 400
Answer: D
Question 40. After exceeding action limits:
A. No action needed
B. Investigation required
C. Increase airflow only
D. Change personnel
Answer: B
Question 41. Examples of operations in Grade A for terminally sterilized products include:
A. Handling washed components
B. Preparation when unusually at risk
C. Filling when unusually at risk
D. Storage
Answer: C
Question 42. Grade C operations for terminally sterilized products include:
A. Aseptic filling
B. Preparation of solutions when unusually at risk
C. Handling sterile components
D. Finished product storage
Answer: B
Question 43. Grade D for terminally sterilized products includes:
A. Aseptic filling
B. Handling components after washing
C. Aseptic connections
D. Final packaging
Answer: B
Question 44. Aseptic preparation must occur in:
A. Grade A
B. Grade B only
C. Grade C
D. Grade D
Answer: A
Question 45. Preparation of solutions to be filtered occurs in:
A. Grade A
B. Grade C
C. Grade D
D. Grade B
Answer: B
Question 46. Microbiological monitoring in aseptic areas should be:
A. Rare
B. Occasional
C. Frequent
D. Not required
Answer: C
Question 47. Surfaces and personnel should be monitored:
A. Only weekly
B. After critical operations
C. Only before operations
D. Never
Answer: B
Question 48. Trends in microbial levels are used to establish:
A. Staff training time
B. Alert and action limits
C. HVAC maintenance invoices
D. Batch size
Answer: B
Question 49. Table 3 microbial limits are:
A. Regulatory specifications
B. Minimum mandatory limits
C. For information only
D. Not permitted
Answer: C
Question 50. Alert/action limit exceedances must be:
A. Ignored
B. Documented and investigated
C. Sent to marketing
D. Bypassed by retesting only
Answer: B
Question 51. Area grade selection should be based on:
A. Financial decisions
B. Process operations and validation
C. Employee preference
D. Equipment age
Answer: B
Question 52. Media fills are used to establish:
A. Airflow velocity
B. Processing hold times
C. Equipment costs
D. Personnel holidays
Answer: B
Question 53. Maximum fill duration is determined by:
A. Room color
B. Aseptic simulation results
C. Management decision
D. Weather conditions
Answer: B
Question 54. Bioburden levels influence:
A. Cleaning materials
B. Required process area grade
C. Batch expiry date
D. Vial closure color
Answer: B
Question 55. Monitoring in Grade C/D is based on:
A. Operator preference
B. Quality risk management
C. Random sampling
D. Annual plan only
Answer: B
Question 56. Environmental parameters like temperature/humidity:
A. Must be fixed at WHO levels
B. Should not interfere with cleanliness
C. Are not important
D. Must match the monograph
Answer: B
Question 57. For Grade A filling, ≥5 μm particles may be present due to:
A. HVAC failure
B. Equipment vibration
C. Product droplets generation
D. High humidity
Answer: C
Question 58. Monitoring locations should be selected based on:
A. Managerial preference
B. Risk analysis and classification studies
C. Room layout only
D. Distance from HEPA filters
Answer: B
Question 59. Automated monitoring systems’ sample volume depends on:
A. Personnel
B. Sampling rate
C. Shift timing
D. Product potency
Answer: B
Question 60. Additional microbiological monitoring is required:
A. Only before product release
B. After sanitation or validation
C. Only in Grade D
D. Never
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products