Moist Heat Sterilization EUGMP- Annex-1
1. Moist heat sterilization can be achieved using:
A) Dry hot air only
B) Steam (direct or indirect)
C) UV radiation
D) Gamma radiation
Answer: B
2. Superheated water systems may be used for:
A) Metal instruments
B) Containers easily damaged by other cycles
C) Rubber stoppers only
D) Paper packaging
Answer: B
3. Items to be sterilised should be packaged in a barrier system that:
A) Prevents air removal
B) Blocks steam penetration
C) Allows air removal and steam penetration
D) Keeps items moist
Answer: C
4. After sterilisation, all loaded items should be:
A) Warm and moist
B) Completely dry
C) Vacuum-sealed
D) Chemically disinfected
Answer: B
5. Load dryness should be confirmed by:
A) Weight measurement
B) Moisture sensors
C) Visual inspection
D) Smell
Answer: C
6. Porous loads (hard goods) must be monitored for:
A) Weight and colour
B) Time, temperature, and pressure
C) Humidity and pH
D) Conductivity
Answer: B
7. Sterilised porous items must be inspected for:
A) Rust
B) Packaging integrity, moisture, damage
C) Chemical residues
D) Colour change
Answer: B
8. Items not fit for purpose after sterilisation must be:
A) Re-sterilised
B) Ignored
C) Removed and investigated
D) Returned to production
Answer: C
9. For prevacuum autoclaves, temperature must be recorded at:
A) The chamber door
B) The top of the load
C) The chamber drain
D) Outside the chamber
Answer: C
10. In steam-in-place systems, temperature must be recorded at:
A) Product contact surfaces only
B) Condensate drain locations
C) Steam generator outlet
D) Air handling unit
Answer: B
11. Porous cycle validation includes calculation of:
A) Steam purity
B) Equilibration and exposure times
C) Load colour stability
D) Chemical concentration
Answer: B
12. Validation of fluid cycles includes:
A) Humidity control
B) Time, temperature, and/or F₀
C) Colour change
D) Bubble formation
Answer: B
13. Critical processing parameters must:
A) Have no tolerance
B) Not be documented
C) Be defined with limits and tolerances
D) Be ignored during routine monitoring
Answer: C
14. Leak tests should be performed:
A) Hourly
B) Weekly normally
C) Annually
D) Only when equipment breaks
Answer: B
15. Leak tests are required when:
A) The cycle uses no vacuum
B) The cycle includes a vacuum phase
C) The load is heavy
D) Using gas cycles
Answer: B
16. Adequate air removal is essential when:
A) Using dry heat
B) No steam is present
C) Air purging is part of the cycle
D) Autoclaves are in storage
Answer: C
17. Air removal verification may include:
A) Measuring smell
B) Daily air removal test cycle
C) Using coloured tape
D) Weight checks
Answer: B
18. Loads should be designed to be free draining to avoid:
A) Rust
B) Condensate build-up
C) Excessive heat
D) Product deformation
Answer: B
19. Damage to non-rigid terminally sterilised containers is prevented by:
A) Increasing cycle speed
B) Using chemical disinfectants
C) Appropriate cycle design and control
D) Reducing the temperature randomly
Answer: C
20. Blow-Fill-Seal or Form-Fill-Seal containers require:
A) Extremely high pressure
B) No steam exposure
C) Protection from distortion during sterilisation
D) Dehydration before the cycle
Answer: C
21. Steam-in-place systems must be designed to ensure:
A) Only half of the system is heated
B) All parts receive required sterilisation treatment
C) Only pipes are heated
D) Only tanks are treated
Answer: B
22. SIP systems must be monitored for:
A) Vibration and noise
B) Temperature, pressure, and time
C) Colour and density
D) Flow rate only
Answer: B
23. SIP monitoring locations must correlate with:
A) The hottest points
B) The fastest-to-heat points
C) Slowest-to-heat locations
D) Areas closest to operators
Answer: C
24. After SIP sterilisation, the system must remain:
A) Completely open
B) Under negative pressure
C) Closed and integral, possibly under positive pressure
D) Unmonitored
Answer: C
25. In superheated water cycles, water must reach:
A) Only the top of the load
B) The drain only
C) All required contact points
D) No product contact points
Answer: C
26. Initial qualification of superheated water cycles must include:
A) Moisture saturation testing
B) Temperature mapping of the entire load
C) Load colour testing
D) Chemical decomposition analysis
Answer: B
27. Routine equipment checks must ensure:
A) Nozzles are blocked for pressure buildup
B) Drains remain closed
C) Nozzles are not blocked and drains are free from debris
D) Temperature gauges are removed
Answer: C
28. Validation of fluids load sterilisation includes:
A) Steam colour testing
B) Heat penetration and reproducibility studies
C) Load density measurements
D) Chemical probe testing
Answer: B
29. All parts of the load in superheated water autoclaves must:
A) Heat uniformly and reach required temperature
B) Remain half-heated
C) Be intentionally uneven
D) Cool before heating
Answer: A
30. Routine temperature monitoring probes must be correlated to:
A) The hottest area
B) The operator room temperature
C) Worst-case load positions
D) The autoclave pressure gauge
Answer: C