Validation of HVAC system MCQs With Answer

Introduction

This quiz set covers Validation of HVAC Systems tailored for M.Pharm students, emphasizing both theory and practical regulatory expectations. Questions address system qualification phases (IQ/OQ/PQ), cleanroom classification (ISO/GMP), air change rates, differential pressure monitoring, HEPA filter testing, airflow patterns, contamination control strategies, environmental monitoring, calibration and documentation. Scenario-based items reinforce risk-based decision making, acceptance criteria, and common validation tests such as particle counting, smoke studies, and recovery tests. These MCQs are designed to deepen understanding, support exam preparation, and help students apply HVAC validation principles in pharmaceutical manufacturing and quality assurance contexts.

Q1. Which activity is primarily performed during Installation Qualification (IQ) of an HVAC system?

• Verifying performance under operational conditions
• Documenting equipment design, location, and utilities
• Performing periodic requalification
• Validating routine cleaning procedures

Correct Answer: Documenting equipment design, location, and utilities

Q2. In HVAC validation, which test is used to verify HEPA filter integrity after installation?

• Particle count trend analysis
• Filter media tensile strength test
• PAO/DOP aerosol challenge (leak test)
• Temperature mapping

Correct Answer: PAO/DOP aerosol challenge (leak test)

Q3. Which cleanroom classification standard is most commonly used internationally for airborne particle limits?

• FDA 21 CFR Part 11
• ISO 14644-1
• ASTM E2500
• WHO Annex 1

Correct Answer: ISO 14644-1

Q4. What does PQ (Performance Qualification) of an HVAC system primarily demonstrate?

• That components are installed per manufacturer recommendations
• The system meets defined performance criteria under routine production conditions
• That design specifications are appropriate
• That maintenance schedules are documented

Correct Answer: The system meets defined performance criteria under routine production conditions

Q5. Which parameter is most critical for maintaining aseptic processing areas and is typically monitored continuously?

• Room paint color
• Differential pressure between adjacent zones
• Operator height
• Light intensity

Correct Answer: Differential pressure between adjacent zones

Q6. For an ISO Class 5 (Grade A) laminar flow hood, which of the following is an appropriate unidirectional airflow velocity range?

• 0.05–0.10 m/s
• 0.3–0.5 m/s
• 1.0–1.5 m/s
• 2.0–3.0 m/s

Correct Answer: 0.3–0.5 m/s

Q7. What is the main objective of a smoke study during HVAC qualification?

• To measure particulate counts
• To visualize airflow patterns and identify turbulence or bypass
• To test HEPA filter efficiency numerically
• To validate temperature control

Correct Answer: To visualize airflow patterns and identify turbulence or bypass

Q8. Which acceptance criterion is typically used for a HEPA filter efficiency test?

• 95% removal of 0.3 µm particles
• 99.97% removal of 0.3 µm particles
• 50% removal of 5 µm particles
• 100% removal of all particle sizes

Correct Answer: 99.97% removal of 0.3 µm particles

Q9. During HVAC OQ (Operational Qualification), which activity would be included?

• Reviewing supplier invoices
• Testing alarms, interlocks, and control setpoints under simulated conditions
• Final product release testing
• Training on gowning procedures

Correct Answer: Testing alarms, interlocks, and control setpoints under simulated conditions

Q10. Which parameter is most useful for determining adequacy of room air cleanliness for aseptic operations?

• Relative humidity only
• Particle counts (number of particles ≥0.5 µm per m3)
• CO2 concentration
• Sound level in dB

Correct Answer: Particle counts (number of particles ≥0.5 µm per m3)

Q11. What is the purpose of a recovery test in HVAC validation?

• To measure filter mechanical strength after stress
• To determine the time required for the system to return to setpoint conditions after a disturbance
• To test electrical backup systems
• To evaluate operator performance

Correct Answer: To determine the time required for the system to return to setpoint conditions after a disturbance

Q12. Which airflow pattern is preferred in Grade A (ISO 5) work zones for aseptic filling to minimize contamination?

• Turbulent mixing airflow
• Unidirectional (laminar) airflow
• Recirculating downflow with high turbulence
• Random crossflow

Correct Answer: Unidirectional (laminar) airflow

Q13. When qualifying cleanroom differential pressures, what cascade principle is usually applied?

• Higher cleanliness areas should be at lower pressure than adjacent less-clean areas
• All rooms must be at equal pressure
• Higher cleanliness areas should be at higher pressure than adjacent less-clean areas
• Pressure cascade is irrelevant if HEPA filters are installed

Correct Answer: Higher cleanliness areas should be at higher pressure than adjacent less-clean areas

Q14. Which instrument is commonly used to perform airborne particle counting during HVAC qualification?

• Hygrometer
• Photometric airborne particle counter
• Manometer
• Sound meter

Correct Answer: Photometric airborne particle counter

Q15. In a risk-based approach to HVAC validation, what determines the extent and frequency of monitoring?

• The color of the facility walls
• Criticality of the product and process, and risk to patient safety
• The age of the HVAC system only
• The number of employees in the facility

Correct Answer: Criticality of the product and process, and risk to patient safety

Q16. Which of the following is a common acceptance criterion for viable particle monitoring in Grade B background areas during aseptic operations?

• Greater than 100 CFU/m3
• 0 CFU/m3 always
• Specific limits defined by site qualification protocol, typically low single digits CFU/m3 during operations
• Not required to monitor viable particles

Correct Answer: Specific limits defined by site qualification protocol, typically low single digits CFU/m3 during operations

Q17. Which regulatory document provides guidance specifically on sterile product manufacture and environmental control?

• ICH Q8(R2)
• EU GMP Annex 1
• ISO 9001
• USP General Notices

Correct Answer: EU GMP Annex 1

Q18. What is the typical purpose of monitoring temperature and relative humidity in HVAC-validated areas?

• To control operator comfort only
• To ensure product stability, operator comfort, and to control static and microbial risks
• To improve electrical efficiency of HVAC
• To determine paint curing times

Correct Answer: To ensure product stability, operator comfort, and to control static and microbial risks

Q19. Which maintenance activity is essential to preserve validated HVAC performance?

• Changing personnel shifts frequently
• Scheduled filter replacement, verification of fan speeds, and periodic calibration of sensors
• Painting the ductwork annually
• Removing all HEPA filters to clean them weekly

Correct Answer: Scheduled filter replacement, verification of fan speeds, and periodic calibration of sensors

Q20. During requalification, which evidence is most important to demonstrate ongoing HVAC control?

• Historical trending of environmental monitoring data showing compliance with acceptance criteria
• The original equipment brochure
• Number of training sessions conducted
• Operator subjective reports of comfort

Correct Answer: Historical trending of environmental monitoring data showing compliance with acceptance criteria

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