Dry Heat Sterilization EUGMP- Annex-1
Questions 1. Dry heat sterilization uses high temperatures of:
A) Water
B) Steam
C) Air or gas
D) Infrared radiation
Answer: C
Questions 2. Dry heat sterilisation is particularly useful for removing:
A) Viruses
B) Moisture
C) Endotoxin/pyrogen
D) Organic solvents
Answer: C
Questions 3. Dry heat sterilisation is often used in preparation of components for:
A) Freeze-drying
B) Final packaging
C) Aseptic filling
D) Visual inspection
Answer: C
Questions 4. Adequate lethality in dry heat sterilisation is achieved by:
A) Pressure and humidity
B) Gas concentration
C) Time and temperature combination
D) Radiation exposure
Answer: C
Questions 5. Dry heat sterilisation may be performed in:
A) Autoclaves only
B) Freeze dryers
C) Ovens or continuous tunnel processes
D) Water baths
Answer: C
Questions 6. Tunnel sterilisation systems must maintain integrity of the grade A zone by:
A) Using UV lamps
B) Maintaining appropriate pressure differentials and airflow
C) Running at maximum belt speed
D) Minimizing temperature changes
Answer: B
Questions 7. Air supplied to dry heat tunnels must pass through:
A) Carbon filters
B) HEPA filters
C) Chemical absorbers
D) Ion exchange filters
Answer: B
Questions 8. Air filter integrity tests on tunnel HEPA filters should be performed at least:
A) Monthly
B) Quarterly
C) Biannually
D) Every 5 years
Answer: C
Questions 9. Tunnel parts that contact sterilised components must be:
A) Painted
B) Disinfected or sterilised
C) Lubricated
D) Replaced weekly
Answer: B
Questions 10. A critical dry heat tunnel parameter is:
A) Steam quality
B) Belt speed (dwell time)
C) Vacuum level
D) UV intensity
Answer: B
Questions 11. Heat penetration studies assess:
A) Power consumption
B) Colour change of materials
C) Heating of the material/article
D) Container closure integrity
Answer: C
Questions 12. Heat distribution/uniformity ensures that:
A) Operators avoid hot surfaces
B) All areas reach effective temperatures
C) Belt speed is increased
D) Air pressure is reduced
Answer: B
Questions 13. Air pressure difference profiles must correlate with:
A) Maintenance intervals
B) Operator training
C) Heat distribution and penetration studies
D) Equipment purchase records
Answer: C
Questions 14. A depyrogenation process must achieve at least:
A) 1 log₁₀ reduction
B) 2 log₁₀ reduction
C) 3 log₁₀ reduction
D) 6 log₁₀ reduction
Answer: C
Questions 15. When a validated depyrogenation process achieves the required endotoxin reduction:
A) Additional sterilisation is still required
B) Sterilisation validation is not required
C) No additional sterilisation requirement applies
D) Product must be reprocessed
Answer: C
Questions 16. Containers spiked with endotoxin during validation must be:
A) Destroyed immediately
B) Loaded randomly
C) Fully reconciled
D) Washed after study
Answer: C
Questions 17. Containers used for validation should be:
A) Smaller than production items
B) Representative of normally processed materials
C) Any available containers
D) Newer than production items
Answer: B
Questions 18. Endotoxin quantification during validation must include assessment of:
A) pH
B) Colour
C) Recovery efficiency
D) Viscosity
Answer: C
Questions 19. Dry heat ovens are typically used to sterilise or depyrogenate:
A) Secondary packaging
B) Office supplies
C) Primary packaging components and starting materials
D) Finished drug products only
Answer: C
Questions 20. Dry heat ovens should be maintained at:
A) Negative pressure
B) Neutral pressure
C) Positive pressure relative to lower grade areas
D) Vacuum conditions
Answer: C
Questions 21. Air entering a dry heat oven must pass through:
A) A carbon filter
B) A HEPA filter
C) A dehumidifier
D) Cooling coils
Answer: B
Questions 22. A critical dry heat oven parameter is:
A) Humidity
B) Air speed
C) Light intensity
D) Chemical concentration
Answer: B
Questions 23. Slow-to-heat spots in the load relate to:
A) Heat penetration
B) Air quality
C) Chamber pressure
D) Load configuration only
Answer: A
Questions 24. Heat distribution studies measure:
A) Thermal uniformity throughout chamber
B) Operator technique
C) Packaging material cost
D) Air filter age
Answer: A
Questions 25. Load pattern and configuration must consider:
A) Minimum and maximum load conditions
B) Operator preference
C) Installation date
D) Production cost
Answer: A
Questions 26. Dry heat sterilisation can be used for:
A) All biological products
B) Cooling vials
C) Active substances and primary packaging components
D) Final sterile filtration
Answer: C
Questions 27. Positive pressure during the hold phase is required unless:
A) The oven is too hot
B) Packaging integrity prevents contamination risk
C) Operator is absent
D) The load is small
Answer: B
Questions 28. Belt speed in tunnel sterilisation directly affects:
A) Particulate load
B) Material cost
C) Dwell time in the sterilising zone
D) Air filter clogging
Answer: C
Questions 29. Air quality within the oven is important because:
A) It affects internal corrosion
B) It may introduce contaminants
C) It changes product potency
D) It regulates humidity
Answer: B
Questions 30. Minimum and maximum temperatures are critical because:
A) They influence operator comfort
B) They determine proper sterilizing lethality
C) They control energy consumption
D) They maintain chamber humidity
Answer: B