Qualification of Autoclave MCQs With Answer

Qualification of Autoclave MCQs With Answer

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Qualification of Autoclave MCQs With Answer

Introduction: This quiz collection covers the qualification and validation of steam sterilization autoclaves, a critical topic in pharmaceutical scale-up and technology transfer. M.Pharm students will review practical and theoretical aspects including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), cycle development, biological and chemical indicators, Bowie-Dick tests, F0 value and lethality concepts, load patterns, heat distribution and penetration studies, and documentation requirements. Questions are designed to deepen understanding of regulatory expectations, validation protocol design, troubleshooting common failures, and interpreting monitoring data to ensure consistent sterility assurance during commercial manufacturing.

Q1. What is the primary objective of Performance Qualification (PQ) for an autoclave?

  • To verify equipment is installed according to manufacturer specifications
  • To demonstrate consistent sterilization under routine production conditions
  • To calibrate temperature and pressure sensors
  • To test alarm and emergency shut-off functions

Correct Answer: To demonstrate consistent sterilization under routine production conditions

Q2. Which biological indicator organism is most commonly used for steam sterilization validation?

  • Geobacillus stearothermophilus spores
  • Bacillus subtilis spores
  • Clostridium botulinum spores
  • Pseudomonas aeruginosa vegetative cells

Correct Answer: Geobacillus stearothermophilus spores

Q3. The Bowie-Dick test is primarily used to detect which issue in a pre-vacuum autoclave?

  • Insufficient sterilant concentration
  • Poor steam penetration due to air entrapment
  • Incorrect sterilization temperature setting
  • Excessive drying time

Correct Answer: Poor steam penetration due to air entrapment

Q4. What does the term F0 represent in steam sterilization?

  • The final pressure achieved in the autoclave chamber
  • The equivalent time at 121.1°C providing the same lethality
  • The frequency of calibration checks per year
  • The fraction of surviving spores after the cycle

Correct Answer: The equivalent time at 121.1°C providing the same lethality

Q5. During an autoclave OQ, which study specifically examines heat penetration into the product?

  • Leak rate test
  • Heat distribution study
  • Heat penetration study
  • Vacuum decay test

Correct Answer: Heat penetration study

Q6. A key acceptance criterion for biological indicator results in PQ is usually:

  • All BI strips show growth after incubation
  • No BI shows growth after specified incubation period
  • At least 50% of BI strips show no growth
  • BI results are not required if chemical indicators are used

Correct Answer: No BI shows growth after specified incubation period

Q7. Chemical indicators in autoclave loads primarily provide information about:

  • Sterility assurance level achieved
  • Temperature and presence of steam exposure
  • Pressure stability during the cycle
  • Microbial load reduction

Correct Answer: Temperature and presence of steam exposure

Q8. Which parameter is NOT directly controlled during a steam sterilization cycle?

  • Temperature
  • Holding time
  • Relative humidity inside the chamber
  • Chamber pressure

Correct Answer: Relative humidity inside the chamber

Q9. What is the typical target temperature for a standard saturated steam sterilization cycle measured by F0?

  • 115°C
  • 121.1°C
  • 134°C
  • 100°C

Correct Answer: 121.1°C

Q10. In autoclave qualification, ‘load mapping’ is used to:

  • Configure software controls for automatic runs
  • Identify cold spots and hot spots within the load
  • Map electrical wiring of the autoclave cabinet
  • Determine required maintenance intervals

Correct Answer: Identify cold spots and hot spots within the load

Q11. Which of the following best describes the role of a data logger during qualification?

  • To measure chemical residue on sterilized products
  • To record temperature, pressure and time profiles during cycles
  • To incubate biological indicators post-cycle
  • To act as a backup steam generator

Correct Answer: To record temperature, pressure and time profiles during cycles

Q12. A failed Bowie-Dick test suggests which immediate corrective action?

  • Increase drying time only
  • Investigate and correct vacuum leak or air removal problem
  • Reduce sterilization temperature to compensate
  • Ignore and continue routine PQ runs

Correct Answer: Investigate and correct vacuum leak or air removal problem

Q13. Which document typically details acceptance criteria, test methods and responsibilities for autoclave qualification?

  • Calibration logbook
  • SOP for laboratory testing only
  • Validation Master Plan and Protocols (IQ/OQ/PQ)
  • Production batch record

Correct Answer: Validation Master Plan and Protocols (IQ/OQ/PQ)

Q14. For sterilization of porous loads, which factor is most critical to ensure sterility?

  • Cooling time after sterilization
  • Steam quality and vacuum phases for air removal and penetration
  • Brand of autoclave manufacturer
  • Type of paper used for documentation

Correct Answer: Steam quality and vacuum phases for air removal and penetration

Q15. Which metric quantifies the probability of a viable microorganism surviving sterilization?

  • Colony forming units (CFU)
  • Sterility Assurance Level (SAL)
  • Bioburden index
  • Moisture content

Correct Answer: Sterility Assurance Level (SAL)

Q16. Why are control charts and trend analysis important for autoclave routine monitoring?

  • They replace the need for biological indicators
  • They help detect early drifts or sudden changes in critical parameters
  • They are only used to satisfy auditors and have no practical use
  • They standardize operator training records

Correct Answer: They help detect early drifts or sudden changes in critical parameters

Q17. Which is a common acceptance criterion for heat distribution studies in OQ?

  • Temperature differences between locations within ±1°C of each other during hold time
  • At least one location reaches 150°C during cycle
  • Pressure must be below atmospheric during hold time
  • All thermocouples must read exactly identical values

Correct Answer: Temperature differences between locations within ±1°C of each other during hold time

Q18. If biological indicators show unexpected growth after a validated cycle, the first step should be:

  • Discard the whole batch without investigation
  • Conduct a root cause investigation including cycle data, BI handling and incubation conditions
  • Increase sterilization temperature for future runs without analysis
  • Immediately change all autoclave gaskets

Correct Answer: Conduct a root cause investigation including cycle data, BI handling and incubation conditions

Q19. During PQ, representative worst-case loads are selected because:

  • They make testing faster and cheaper
  • They ensure the autoclave can sterilize the most challenging items under routine conditions
  • They reduce the need for calibration of instruments
  • They are easier to place into the chamber

Correct Answer: They ensure the autoclave can sterilize the most challenging items under routine conditions

Q20. Which regulatory expectation applies to autoclave qualification documentation?

  • Records may be handwritten with no dates required
  • Documentation must be complete, traceable, version controlled and retained per regulations
  • Only verbal approval from supervisor is required
  • Expired validation protocols are acceptable if noted

Correct Answer: Documentation must be complete, traceable, version controlled and retained per regulations

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