Terminal Sterilization WHO GMP
Question 1. Heat-sterilization cycles should be recorded using:
A. Visual inspection
B. Time/temperature chart
C. Sound alarms
D. Pressure only
Answer: B
Question 2. Temperature during heat sterilization should be measured at:
A. The hottest part
B. The center of the chamber only
C. The coolest part of the load
D. The chamber walls
Answer: C
Question 3. The coolest point for temperature measurement is determined during:
A. Routine operations
B. Validation
C. Equipment cleaning
D. Packaging
Answer: B
Question 4. Temperature should preferably be checked against:
A. A humidity probe
B. A weight scale
C. A second independent temperature probe
D. A visual thermometer
Answer: C
Question 5. Sterilization records must be available for:
A. Weekly cycles only
B. Every sterilization run
C. Only large batches
D. Only failed cycles
Answer: B
Question 6. Chemical or biological indicators:
A. Replace physical controls
B. Do not replace physical controls
C. Are unnecessary
D. Are mandatory only for liquids
Answer: B
Question 7. The sterilizing time begins after:
A. Loading the chamber
B. The entire load reaches target temperature
C. Chamber door closes
D. Cycle ends
Answer: B
Question 8. Required heating time must be determined for:
A. Each operator
B. Each type of load
C. Each batch size
D. All steam sterilizers
Answer: B
Question 9. After high-temperature sterilization, contamination risk arises during:
A. Preheating
B. Cooling
C. Storage
D. Unloading
Answer: B
Question 10. Fluids or gases used during cooling must be:
A. Chilled
B. Sterilized
C. Colored
D. Pressurized
Answer: B
Moist Heat Sterilization
Question 11. Moist heat sterilization requires monitoring of:
A. Only pressure
B. Only temperature
C. Both temperature and pressure
D. Neither
Answer: C
Question 12. Control instrumentation should be:
A. The same as monitoring instrumentation
B. Independent from monitoring instrumentation
C. Optional
D. Manual only
Answer: B
Question 13. Automated control systems must be:
A. Avoided
B. Validated
C. Used without checking
D. Replaced yearly
Answer: B
Question 14. System faults during sterilization should be:
A. Ignored
B. Registered and observed
C. Reset automatically only
D. Hidden from operators
Answer: B
Question 15. Independent temperature readings should be checked against:
A. Pressure readings
B. Chamber humidity
C. Chart recorder
D. Room temperature
Answer: C
Question 16. The drain temperature may need recording when:
A. It is above 200°C
B. The load is large
C. A drain exists at chamber bottom
D. Only liquids are sterilized
Answer: C
Question 17. Leak tests are required when:
A. A humidification phase is used
B. A vacuum phase is part of the cycle
C. The sterilizer is new
D. A pressure gauge is unavailable
Answer: B
Question 18. Items sterilized by moist heat should be wrapped to allow:
A. Only heat penetration
B. Steam penetration and air removal
C. Air retention
D. UV penetration
Answer: B
Question 19. Wrapping must prevent:
A. Water absorption
B. Recontamination after sterilization
C. Temperature changes
D. Steam circulation
Answer: B
Question 20. Stainless steel sterilization containers must allow:
A. UV light entry
B. Steam entry and air exit
C. Air trapping
D. Dry heat penetration only
Answer: B
Question 21. All load parts must be in contact with:
A. Dry heat
B. Filtered air
C. Water or saturated steam
D. Ionizing radiation
Answer: C
Question 22. The steam used for sterilization must be:
A. Sterile and of suitable quality
B. Untreated
C. Cooled below 60°C
D. Mixed with additives
Answer: A
Question 23. Steam must be tested for:
A. Only endotoxins
B. Dryness, superheat, and non-condensable gases
C. UV reflectivity
D. Color
Answer: B
Dry Heat Sterilization
Question 24. Dry heat sterilization is suitable for:
A. Aqueous solutions
B. Non-aqueous liquids
C. Water-based injections
D. Sterile filters
Answer: B
Question 25. Dry heat chambers must have:
A. Air circulation and positive pressure
B. UV lamps
C. No ventilation
D. Ambient airflow
Answer: A
Question 26. Air supplied to dry heat systems must pass through:
A. Activated carbon
B. Microorganism-retaining filters (e.g., HEPA)
C. UV lights
D. Water baths
Answer: B
Question 27. Pyrogen removal validation requires:
A. Sterility testing
B. Endotoxin challenge tests
C. Visual checking
D. Pressure testing
Answer: B
Radiation Sterilization
Question 28. Radiation sterilization is mainly for:
A. Heat-stable materials
B. Heat-sensitive materials
C. Liquids
D. Suspensions
Answer: B
Question 29. UV irradiation is:
A. A valid terminal sterilization method
B. Not acceptable for terminal sterilization
C. Suitable for sealed vials
D. Preferred for powders
Answer: B
Question 30. Radiation use must be confirmed to cause:
A. Degradation only
B. No deleterious product effects
C. Increased viscosity
D. Color change
Answer: B
Question 31. When using outside radiation contractors, manufacturers must:
A. Avoid validation
B. Ensure requirements are met and process validated
C. Ignore internal quality rules
D. Rely solely on contractor testing
Answer: B
Question 32. Radiation dose must be measured using:
A. Pressure gauges
B. Dosimeters
C. Thermometers
D. Volumetric flasks
Answer: B
Question 33. Dosimeters must provide measurement of:
A. Exposure time only
B. Radiation dose received by product
C. Ambient temperature
D. Humidity
Answer: B
Question 34. Plastic dosimeters must be used:
A. Before calibration
B. With expired calibration
C. Within calibration time-limits
D. Only once per cycle
Answer: C
Question 35. Dosimeter absorbance should be read:
A. Immediately after calibration
B. Shortly after exposure
C. After 1 month
D. Before irradiation
Answer: B
Question 36. Color discs used during radiation indicate:
A. Successful sterilization
B. Only whether the package was irradiated
C. Exact dose
D. Moisture content
Answer: B
Question 37. Validation should account for variations in:
A. Lighting
B. Package density
C. Operator experience
D. Cycle speed
Answer: B
Question 38. Irradiated and non-irradiated materials must be:
A. Stored together
B. Prevented from mix-up
C. Marked only by batch number
D. Kept in plastic bags
Answer: B
Question 39. Each package should carry:
A. Radiation-sensitive indicator
B. Product price
C. Storage temperature
D. Test certificate
Answer: A
Question 40. Total radiation dose must be administered:
A. At any random time
B. Within a predetermined period
C. All at once only
D. Slowly over months
Answer: B
Gas and Fumigant Sterilization
Question 41. Gas sterilization should be used:
A. For all products
B. Only when no suitable alternative exists
C. Always before irradiation
D. For tablets
Answer: B
Question 42. Common gases used include:
A. Nitrogen
B. Ethylene oxide and hydrogen peroxide vapor
C. Oxygen
D. Helium
Answer: B
Question 43. Ethylene oxide should be used:
A. As the first choice
B. Only when no other method is practicable
C. For all heat-stable products
D. Only for liquids
Answer: B
Question 44. Validation must show that gas sterilization:
A. Leaves residues unchanged
B. Does not damage the product
C. Is faster than heat
D. Changes product color
Answer: B
Question 45. Degassing time must reduce residues to:
A. Zero
B. Acceptable defined limits
C. Visual pass/fail
D. Negative pressure
Answer: B
Question 46. Packaging materials:
A. Do not affect gas sterilization
B. Significantly affect the process
C. Must be removed
D. Should be metal only
Answer: B
Question 47. Direct contact of gas with microorganisms is:
A. Not required
B. Essential
C. Optional
D. Required only for liquids
Answer: B
Question 48. Microorganisms may be enclosed in:
A. Water
B. Crystals or dried proteins
C. Plastic bags
D. Metal caps
Answer: B
Question 49. Before gas exposure, materials must reach:
A. Desired humidity and temperature
B. Absolute dryness
C. Room temperature only
D. Vacuum conditions
Answer: A
Question 50. Biological indicators must be placed:
A. Only on chamber walls
B. Throughout the load
C. Only near the door
D. Only in the center
Answer: B
Question 51. Information from biological indicators forms part of the:
A. Packaging design
B. Batch record
C. Cleaning schedule
D. Supplier evaluation
Answer: B
Question 52. Biological indicators must be stored per:
A. Operator preference
B. Manufacturer instructions
C. Sterilizer brand
D. Local climate
Answer: B
Question 53. Biological indicator performance must be checked using:
A. Negative controls
B. Positive controls
C. Temperature probes
D. Blank tests
Answer: B
Question 54. Gas sterilization cycle records must include:
A. Only time
B. Pressure, temperature, humidity, gas concentration
C. Only operator name
D. Only product type
Answer: B
Question 55. Pressure and temperature during gas sterilization must be:
A. Estimated
B. Recorded on a chart
C. Measured visually
D. Checked only once
Answer: B
Question 56. After gas sterilization, loads must be stored:
A. In sealed containers
B. In ventilated controlled conditions
C. Under refrigeration
D. In darkness
Answer: B
Question 57. Post-sterilization aeration is needed to:
A. Ensure dryness
B. Reduce residual gas levels
C. Improve packaging
D. Increase humidity
Answer: B
Question 58. Degassing requirements must be:
A. Avoided
B. Validated
C. Randomly set
D. Only operator-based
Answer: B
Question 59. Residual gas levels must fall to:
A. Operator preference
B. Prescribed limits
C. Zero
D. Average values
Answer: B
Question 60. A validated gas sterilization process ensures:
A. No need for batch records
B. Safe product free of harmful residues
C. Higher product cost
D. No need for monitoring
Answer: B
Terminally Sterilized Products WHO GMP
Question 61. Physical controls in sterilization include:
A. Biological indicators
B. Time and temperature records
C. Color change strips only
D. Dosimeter color
Answer: B
Question 62. Heat-sterilization charts must have:
A. No scaling
B. A suitably large scale
C. Only pressure readings
D. Only time intervals
Answer: B
Question 63. A second independent temperature probe helps ensure:
A. Faster sterilization
B. Accuracy and reliability
C. Lower pressure
D. Better cooling
Answer: B
Question 64. Load heating time varies based on:
A. Operator skill
B. Load type
C. Chamber color
D. Air flow
Answer: B
Question 65. Cooling fluids contacting product must be:
A. Distilled
B. Sterilized
C. Heated
D. Alkaline
Answer: B
Question 66. Direct contact of steam with load ensures:
A. Faster drying
B. Proper sterilization
C. Chamber cleaning
D. Faster unloading
Answer: B
Question 67. Radiation dose measurement ensures:
A. Product color consistency
B. Adequate exposure
C. Reduced temperature
D. Faster release
Answer: B
Question 68. Gas sterilization records must be part of:
A. Warehouse logs
B. Batch records
C. Supplier certification
D. Design documents
Answer: B
Question 69. Ventilated post-sterilization storage reduces:
A. Moisture
B. Residual gases
C. Product labeling
D. Mechanical damage
Answer: B
Question 70. Waiting time before gas sterilization must balance:
A. Humidity equilibration vs. minimizing delay
B. Pressure buildup
C. Container cooling
D. Light exposure
Answer: A
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products