Sterilization by Heat EUGMP- Annex-1
1. Each heat sterilization cycle should be recorded:
A. Only in handwritten logs
B. Either electronically or by hardcopy
C. Only when deviations occur
D. Only if requested by inspectors
Answer: B
2. Control and monitoring systems for heat sterilisation should include:
A. No redundancy
B. Only visual indicators
C. Safeguards and/or redundancy to detect non-conforming cycles
D. Single probes only
Answer: C
3. An example of suitable redundancy for heat sterilisation is:
A. Duplicate packaging lines
B. Use of duplex/double probes connected to independent systems
C. Double-layered containers
D. Extra computer terminals
Answer: B
4. Temperature probe positions should be determined:
A. Randomly during routine operation
B. Based on operator preference
C. During validation, considering system design
D. Only after deviations occur
Answer: C
5. Validation studies for probe placement should include:
A. Only reviewing historical data
B. Verification using an independent monitoring probe
C. Operator interviews
D. External laboratory testing only
Answer: B
6. The purpose of selecting appropriate probe locations is to:
A. Measure only the hottest point
B. Correctly record and represent routine cycle conditions
C. Allow operators to reduce documentation
D. Simplify cleaning
Answer: B
7. Before the sterilising time begins, the whole load should:
A. Reach room temperature
B. Reach the required temperature
C. Be visually inspected
D. Be sealed
Answer: B
8. When a reference probe is used to control the cycle, special consideration must be given to:
A. Reducing the number of probes
B. Ensuring the load probe temperature is within defined limits before starting the cycle
C. Using the probe only after sterilisation
D. Only monitoring pressure
Answer: B
9. After completion of the high-temperature phase, precautions are required:
A. Only for liquid loads
B. To avoid contamination during cooling
C. Only in manual systems
D. Only for sealed products
Answer: B
10. Any cooling liquid or gas coming into contact with sterilised materials must be:
A. Filtered
B. Chemically treated
C. Sterilised
D. At room temperature
Answer: C
11. Parametric release may be used only when:
A. Authorized
B. Deemed faster by the manufacturer
C. Manual charts are unavailable
D. Environmental monitoring fails
Answer: A
12. Products under parametric release require:
A. No validation
B. A robust lifecycle validation and routine monitoring system
C. Only sterility testing
D. Reduced documentation
Answer: B
13. The system supporting parametric release should be:
A. Reviewed once every decade
B. Reviewed periodically
C. Changed only during audits
D. Removed after process validation
Answer: B
14. Further guidance on parametric release is found in:
A. Annex 11
B. Annex 15
C. Annex 17
D. Annex 1
Answer: C
15. The purpose of detecting non-conforming sterilisation cycles is to:
A. Save energy
B. Abort or fail the cycle
C. Allow immediate product release
D. Reduce calibration frequency
Answer: B