Utility validation – water, steam, HVAC, air MCQs With Answer

Introduction: Utility validation – water, steam, HVAC, air MCQs With Answer is designed for M.Pharm students preparing for exams and professional roles in pharmaceutical quality and regulatory affairs. This set focuses on validation principles, testing strategies, monitoring requirements and regulatory expectations for critical utilities — purified water, water for injection (WFI), steam for sterilization, HVAC systems and compressed/clean air. Questions cover system design, documentation (DQ/IQ/OQ/PQ), microbiological and chemical monitoring, particle and HEPA filter testing, steam quality and condensate control, routine requalification and alarm management. These MCQs reinforce theory, practical considerations and decision-making used in Good Regulatory Practices for pharmaceutical utilities.

Q1. What is the primary purpose of validating pharmaceutical utilities such as water, steam, HVAC and air systems?

• To reduce energy consumption of the facility
• To ensure equipment lifespan is maximized
• To demonstrate and document that utilities consistently meet predefined quality attributes required for product safety and regulatory compliance
• To increase production capacity

Correct Answer: To demonstrate and document that utilities consistently meet predefined quality attributes required for product safety and regulatory compliance

Q2. Which document defines the user’s functional and quality requirements for a utility system and is the starting point for validation activities?

• Site Master File
• Validation Master Plan
• Design Qualification (DQ)
• User Requirements Specification (URS)

Correct Answer: User Requirements Specification (URS)

Q3. In pharmaceutical water systems, why is Total Organic Carbon (TOC) routinely monitored?

• TOC directly measures microbial counts in real time
• High TOC indicates probable non-volatile chemical contamination and organic load that can support microbial growth
• TOC is used to calculate conductivity
• TOC determines water hardness

Correct Answer: High TOC indicates probable non-volatile chemical contamination and organic load that can support microbial growth

Q4. Which type of steam is preferred for terminal sterilization of product contact equipment and why?

• Superheated steam, because it provides extra energy for faster sterilization
• Saturated clean steam with minimal non-condensable gases, because it transfers heat efficiently and ensures reproducible sterilization
• Dry steam, because it eliminates condensate formation
• Wet steam from boilers without filtration, because it is cost effective

Correct Answer: Saturated clean steam with minimal non-condensable gases, because it transfers heat efficiently and ensures reproducible sterilization

Q5. When validating a steam-in-place (SIP) cycle for a sterilizer or manifold, what is a critical parameter to document?

• Electrical power consumption during the cycle
• Maximum steam pressure at the boiler room only
• Time-temperature profile at product-contact and representative locations showing required sterile exposure
• The color of steam condensate

Correct Answer: Time-temperature profile at product-contact and representative locations showing required sterile exposure

Q6. For HVAC cleanroom qualification, which order of qualification phases is correct?

• PQ → OQ → IQ → DQ
• IQ → DQ → OQ → PQ
• DQ → IQ → OQ → PQ
• OQ → PQ → DQ → IQ

Correct Answer: DQ → IQ → OQ → PQ

Q7. Which test aerosol is commonly used to challenge HEPA filters during integrity testing in pharmaceutical HVAC systems?

• Salt aerosol (NaCl) only
• Polyalphaolefin (PAO) or DEHS aerosol
• Carbon black aerosol
• Latex beads in suspension

Correct Answer: Polyalphaolefin (PAO) or DEHS aerosol

Q8. What is the main regulatory rationale for segregating purified water (PW) and water for injection (WFI) in pharma facilities?

• PW is cheaper to produce than WFI so it is reserved for non-critical tasks
• WFI must meet additional requirements for endotoxin and sterility for parenteral uses, while PW is for non-parenteral applications
• There is no practical difference; segregation is historical only
• PW has higher temperature than WFI

Correct Answer: WFI must meet additional requirements for endotoxin and sterility for parenteral uses, while PW is for non-parenteral applications

Q9. During routine monitoring of HVAC and cleanroom air, which combination of measurements provides both contamination and functional performance assessment?

• Only carbon dioxide and oxygen levels
• Non-viable particle counts and viable microbial air sampling
• Thermal imaging and vibration analysis
• Relative humidity only

Correct Answer: Non-viable particle counts and viable microbial air sampling

Q10. Why are pressure differentials between adjacent cleanroom areas maintained and monitored?

• To ensure staff comfort during long shifts
• To prevent the migration of contaminants from lower to higher cleanliness areas and maintain unidirectional flow of air
• To control light levels in production areas
• To save on HVAC energy costs by reducing airflow

Correct Answer: To prevent the migration of contaminants from lower to higher cleanliness areas and maintain unidirectional flow of air

Q11. Which parameter is most indicative of steam quality affecting sterilization efficacy?

• Steam color
• Percentage of non‑condensable gases and dryness fraction
• pH of condensate only
• Boiler fuel type

Correct Answer: Percentage of non‑condensable gases and dryness fraction

Q12. What is the role of a Building Management System (BMS) in utility validation and routine GMP operations?

• To provide decorative lighting controls for office areas
• To continuously log critical HVAC and utility parameters, alarm deviations and support periodic review and trending
• To replace microbiological testing
• To manufacture purified water automatically

Correct Answer: To continuously log critical HVAC and utility parameters, alarm deviations and support periodic review and trending

Q13. Which of the following is a critical consideration when sampling a circulating purified water loop for microbiology?

• Samples should be taken only from the first sampling point near the storage tank
• Sampling should include representative remote and point-of-use locations, avoiding dead legs unless they are part of routine monitoring
• Only composite samples from multiple points are allowed by regulations
• Samples can be taken only after chlorination

Correct Answer: Sampling should include representative remote and point-of-use locations, avoiding dead legs unless they are part of routine monitoring

Q14. For compressed air used in filling sterile products, which attributes must be controlled and validated?

• Particle counts, oil content and microbial contamination
• Color and taste of air
• Only pressure matters, not purity
• Noise level of the compressor

Correct Answer: Particle counts, oil content and microbial contamination

Q15. What is the purpose of conducting a challenge test (e.g., using biological indicators) when qualifying sterilization utilities or processes?

• To verify that the sterilizer door closes properly
• To demonstrate the process achieves the required microbial reduction under realistic load and worst-case conditions
• To calibrate pressure gauges
• To test personnel competence only

Correct Answer: To demonstrate the process achieves the required microbial reduction under realistic load and worst-case conditions

Q16. Which action is expected when routine monitoring of a utility indicates an excursion beyond the defined action limit?

• Ignore it if production is on schedule
• Immediate investigation, containment where required, root cause analysis and corrective/preventive actions, with documentation
• Only notify the staff and resume normal operation
• Replace the entire utility system immediately

Correct Answer: Immediate investigation, containment where required, root cause analysis and corrective/preventive actions, with documentation

Q17. What is the most appropriate frequency for full requalification (PQ) of HVAC systems in critical sterile manufacturing areas under normal conditions?

• Never required after initial qualification
• At defined intervals such as annually or when significant changes occur, as per quality risk assessment and regulatory expectations
• Daily full PQ
• Only if a regulatory inspector requests it

Correct Answer: At defined intervals such as annually or when significant changes occur, as per quality risk assessment and regulatory expectations

Q18. Which characteristic of condensate in steam systems can indicate inadequate steam quality or heat transfer problems?

• Condensate temperature equals saturation temperature at steam pressure
• Condensate contains oily film, discoloration or unusual odors indicating carryover or contamination
• Condensate is clear and free of particles
• Condensate pH is neutral in all cases

Correct Answer: Condensate contains oily film, discoloration or unusual odors indicating carryover or contamination

Q19. During DQ/IQ/OQ/PQ lifecycle, which activity is typically performed during Operational Qualification (OQ)?

• High-level business case and conceptual layout
• Verification that installed components operate over their intended ranges and alarm setpoints and that controls function as designed
• Routine monitoring during long-term production only
• Disposal of obsolete equipment

Correct Answer: Verification that installed components operate over their intended ranges and alarm setpoints and that controls function as designed

Q20. Which water type is the preferred source for preparing parenteral products and for use in injectable drug manufacturing due to its stringency for endotoxin and sterility?

• Tap water
• Purified Water (PW)
• Water for Injection (WFI)
• RO permeate only

Correct Answer: Water for Injection (WFI)

Download