Qualification of autoclaves MCQs With Answer

Qualification of autoclaves MCQs With Answer

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Introduction

This quiz collection on the Qualification of Autoclaves is designed specifically for M.Pharm students studying Pharmaceutical Validation. It covers the essential theory and practical aspects of autoclave qualification including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Questions explore steam generation and quality, Bowie‑Dick tests, biological and chemical indicators, D‑, Z‑ and F0 concepts, cycle development for different product types, probe placement, mapping protocols, acceptance criteria and routine monitoring. Answers are provided to help reinforce understanding and prepare you for exams and laboratory practice. Use these MCQs to test and deepen your knowledge of autoclave validation principles and regulatory expectations.

Q1. What is the primary objective of Installation Qualification (IQ) for an autoclave?

  • To demonstrate consistent microbial kill during routine sterilization cycles
  • To verify that the autoclave is installed correctly and all factory and site utilities meet specifications
  • To optimize cycle parameters for different product loads
  • To perform daily Bowie‑Dick testing

Correct Answer: To verify that the autoclave is installed correctly and all factory and site utilities meet specifications

Q2. Which test is recommended daily for a prevacuum (dynamic air removal) steam sterilizer to detect residual air and non‑condensable gases?

  • Biological indicator test using Geobacillus stearothermophilus
  • Bowie‑Dick or equivalent air removal test
  • Vacuum leak test with soap solution
  • Steam dryness fraction measurement

Correct Answer: Bowie‑Dick or equivalent air removal test

Q3. In Performance Qualification (PQ) of an autoclave, where should biological indicators (BIs) typically be placed?

  • Only near the steam entry jet
  • At defined worst‑case (coldest, least accessible) locations within representative loads
  • In the autoclave control panel
  • Exclusively on the outermost trays

Correct Answer: At defined worst‑case (coldest, least accessible) locations within representative loads

Q4. What does the D‑value represent in steam sterilization validation?

  • The time required at a specified temperature to reduce the microbial population by 90% (one log)
  • The temperature increase required to reduce D‑value by a factor of ten
  • The total sterilization time including cooling
  • The pressure required to achieve saturation temperature

Correct Answer: The time required at a specified temperature to reduce the microbial population by 90% (one log)

Q5. The Z‑value in thermal inactivation kinetics is defined as which of the following?

  • The temperature change required to change the D‑value by a factor of 10
  • The time necessary to destroy 12 log of spores
  • The activation energy of microbial inactivation in kJ/mol
  • The time at 121°C to achieve commercial sterility

Correct Answer: The temperature change required to change the D‑value by a factor of 10

Q6. What does F0 (F zero) value represent in moist heat sterilization?

  • The sterilization equivalent minutes at 121.1°C with z = 10°C
  • The steam quality expressed as dryness fraction
  • The final temperature achieved during a cycle
  • The frequency of preventive maintenance per year

Correct Answer: The sterilization equivalent minutes at 121.1°C with z = 10°C

Q7. For sterilization of aqueous pharmaceutical formulations in sealed bottles, which autoclave cycle characteristic is most important to control?

  • Rapid depressurization to increase cooling rate
  • Controlled slow exhaust and appropriate exposure time to avoid bumping and superheating
  • Maximum steam injection to create turbulent flow
  • Short heat‑up time regardless of product complexity

Correct Answer: Controlled slow exhaust and appropriate exposure time to avoid bumping and superheating

Q8. Which biological indicator organism is most commonly used to validate moist heat sterilization cycles?

  • Geobacillus stearothermophilus (previously Bacillus stearothermophilus)
  • Bacillus atrophaeus
  • Escherichia coli
  • Saccharomyces cerevisiae

Correct Answer: Geobacillus stearothermophilus (previously Bacillus stearothermophilus)

Q9. During temperature mapping (thermal distribution study) for PQ, what is the key acceptance consideration?

  • All recorded temperatures must reach at least 140°C
  • Recorded temperatures and exposure times at worst‑case locations must meet predefined acceptance criteria demonstrating lethality for the specified F0
  • Only the chamber seam temperature is relevant
  • The fastest heating locations determine cycle acceptance

Correct Answer: Recorded temperatures and exposure times at worst‑case locations must meet predefined acceptance criteria demonstrating lethality for the specified F0

Q10. Which parameter is most indicative of steam quality for sterilization effectiveness?

  • Steam color
  • Steam dryness fraction (percentage of vapor vs liquid water)
  • Chamber pressure alone
  • Time since last maintenance

Correct Answer: Steam dryness fraction (percentage of vapor vs liquid water)

Q11. What is the principal purpose of a vacuum leak test in autoclave qualification?

  • To measure biological kill directly
  • To ensure the chamber and door seals are tight and air removal/sterility conditions can be achieved
  • To test steam temperature accuracy
  • To calibrate pressure sensors

Correct Answer: To ensure the chamber and door seals are tight and air removal/sterility conditions can be achieved

Q12. Which of the following is a common acceptance criterion for Bowie‑Dick test results?

  • Complete color change of the test pack indicating effective air removal
  • No growth of biological indicators after 24 hours
  • Negative pressure decay within 5 minutes
  • Chamber pressure reaching 3 bar

Correct Answer: Complete color change of the test pack indicating effective air removal

Q13. During OQ of an autoclave, which activities are typically performed?

  • Verification of installation drawings only
  • Demonstration that all controls, interlocks, alarms and instrumentation operate across the intended ranges and tolerances
  • Routine daily cleaning procedures
  • Placement of BIs in routine production loads only

Correct Answer: Demonstration that all controls, interlocks, alarms and instrumentation operate across the intended ranges and tolerances

Q14. What is the most appropriate loading pattern consideration when qualifying an autoclave for heat‑sensitive packaged products?

  • Maximizing steam flow by blocking vents with trays
  • Using representative packaging, spacing, and rack configurations to create worst‑case heat penetration conditions
  • Filling all trays tightly to minimize movement
  • Irradiating samples before autoclaving

Correct Answer: Using representative packaging, spacing, and rack configurations to create worst‑case heat penetration conditions

Q15. What is a correct interpretation of a 12‑log reduction claim in sterilization?

  • The process heats a product to 12°C above ambient
  • A reduction of a microbial population by 10^12, commonly used for sterile pharmaceutical products
  • The cycle runs for 12 minutes at any temperature
  • An indicator changes color 12 times during the cycle

Correct Answer: A reduction of a microbial population by 10^12, commonly used for sterile pharmaceutical products

Q16. Which documentation is essential to retain after completing an autoclave qualification study?

  • Only the final acceptance statement
  • IQ/OQ/PQ protocols, raw data, calibration certificates, deviation reports and final approved reports
  • Only operator training records
  • Just the biological indicator growth curves

Correct Answer: IQ/OQ/PQ protocols, raw data, calibration certificates, deviation reports and final approved reports

Q17. If non‑condensable gases are present in the steam supply, which effect is most likely during sterilization?

  • Improved heat transfer and faster lethality
  • Formation of cold spots and reduced sterilization effectiveness
  • Increased steam purity resulting in shorter cycles
  • Automatic correction by the autoclave controller

Correct Answer: Formation of cold spots and reduced sterilization effectiveness

Q18. Which practice is recommended when validating sterilization cycles for packaged porous loads (e.g., surgical linens) in a steam autoclave?

  • Use a prevacuum cycle to assure effective air removal and steam penetration
  • Always use the shortest possible exposure time
  • Exclude biological indicators since packaging protects them
  • Place temperature probes only outside the packages

Correct Answer: Use a prevacuum cycle to assure effective air removal and steam penetration

Q19. During PQ mapping, why are multiple temperature probes used across the chamber?

  • To reduce the cost of validation studies
  • To identify the coldest and hottest locations and ensure the entire load meets lethality criteria
  • To average readings and hide worst‑case spots
  • Because single‑point measurement is more accurate

Correct Answer: To identify the coldest and hottest locations and ensure the entire load meets lethality criteria

Q20. What is an appropriate frequency for repeating full PQ (thermal mapping with BIs) after a major autoclave repair or relocation?

  • Only perform a visual inspection; PQ is not required
  • Repeat full PQ before returning to routine production use
  • Wait one year before revalidating
  • Perform a single Bowie‑Dick test and resume operations

Correct Answer: Repeat full PQ before returning to routine production use

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