Utilities & Equipment Layout MCQs With Answer

Utilities & Equipment Layout MCQs With Answer

This quiz collection is designed for M.Pharm students studying MIP 203T – Pharmaceutical Production Technology. It focuses on utilities (water systems, steam, compressed air, HVAC, gases) and principles of equipment layout in pharmaceutical manufacturing. Questions probe deeper concepts like cleanroom pressure cascades, HEPA filtration, CIP/SIP processes, validation stages (IQ/OQ/PQ), piping design issues (dead legs), and redundancy strategies (N+1). Each question aims to test applied knowledge relevant to GMP-compliant facility design, operation, and monitoring, helping students prepare for exams and real-world production challenges. Answers are provided to support self-assessment and targeted revision.

Q1. Which of the following best describes the primary purpose of utilities in a pharmaceutical manufacturing facility?

• To reduce production costs by minimizing energy usage
• To provide controlled services (water, steam, air, HVAC) that support process integrity and product quality
• To supply packaging materials and labels
• To manage human resources and staffing schedules

Correct Answer: To provide controlled services (water, steam, air, HVAC) that support process integrity and product quality

Q2. Which water grade is required for final formulation and sterilization processes for parenteral products?

• Potable water
• Purified water (PW)
• Water for Injection (WFI)
• Distilled water

Correct Answer: Water for Injection (WFI)

Q3. HEPA filters in pharmaceutical cleanroom HVAC systems are primarily used to:

• Remove gaseous contaminants such as VOCs
• Remove particles and microorganisms down to approximately 0.3 µm with very high efficiency
• Control room temperature and humidity
• Provide sound insulation for the AHU

Correct Answer: Remove particles and microorganisms down to approximately 0.3 µm with very high efficiency

Q4. In a pressure cascade for cleanrooms, how is differential pressure typically arranged?

• Higher differential pressure in less clean areas to drive air into cleaner rooms
• Same pressure in all rooms to maintain equilibrium
• Higher differential pressure in cleaner areas to ensure airflow from clean to less clean zones
• Negative pressure in the cleanest rooms to prevent contamination

Correct Answer: Higher differential pressure in cleaner areas to ensure airflow from clean to less clean zones

Q5. Which characteristic is most critical for compressed air used in critical pharmaceutical processes?

• High humidity to prevent electrostatic discharge
• Oil-laden, unfiltered air to lubricate pneumatic equipment
• Dry, oil-free air with particulate and microbial removal, validated to specification
• High oxygen content for enhanced reaction rates

Correct Answer: Dry, oil-free air with particulate and microbial removal, validated to specification

Q6. For steam sterilization of equipment, which steam quality is required?

• Superheated steam with high dryness fraction and no condensate carryover
• Saturated, clean steam free of oil and particulates with minimal carryover
• Low pressure wet steam for rapid cooling
• Steam mixed with air to improve heat transfer

Correct Answer: Saturated, clean steam free of oil and particulates with minimal carryover

Q7. What does CIP stand for and what is its main purpose in pharmaceutical equipment?

• Control-In-Process; to monitor manufacturing variables continuously
• Clean-In-Place; to clean internal surfaces of process equipment without disassembly
• Calibration-In-Place; to calibrate sensors installed on equipment
• Cool-In-Process; to rapidly cool product in vessels

Correct Answer: Clean-In-Place; to clean internal surfaces of process equipment without disassembly

Q8. SIP commonly refers to Sterilize-In-Place. What is a primary advantage of SIP systems?

• They eliminate the need for routine maintenance of valves
• They allow sterilization of interior surfaces without breaking down equipment, reducing contamination risk
• They reduce the amount of steam required compared to autoclaves
• They are only used for terminal sterilization of final packaged goods

Correct Answer: They allow sterilization of interior surfaces without breaking down equipment, reducing contamination risk

Q9. When designing equipment layout, which flow pattern best minimizes cross-contamination and material handling conflicts?

• Randomized islands of equipment mixed by function
• Unidirectional linear flow from raw materials → processing → packaging → finished goods
• Centralized single-room processing for all products
• Layout focused only on maximizing aesthetic appeal

Correct Answer: Unidirectional linear flow from raw materials → processing → packaging → finished goods

Q10. In utility design the redundancy concept “N+1” means:

• There are N units and one unit operates as a standby, providing one unit above required capacity for reliability
• One unit supports N units simultaneously
• There is only one critical unit and N non-critical units
• All units are operated at N% capacity plus an additional 1%

Correct Answer: There are N units and one unit operates as a standby, providing one unit above required capacity for reliability

Q11. The standard stages of validation for a new utility system (e.g., water or HVAC) are:

• Design Qualification (DQ) only
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Commissioning without qualification
• Process Validation followed by Routine Monitoring only

Correct Answer: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Q12. What is a “dead leg” in piping systems and why is it problematic?

• A pipe that is fully insulated; it improves temperature control
• A stagnant branch or section with minimal flow where product or water can stagnate, promoting microbial growth
• A section designed for sampling; it enhances quality control
• A high-flow bypass line that increases system redundancy

Correct Answer: A stagnant branch or section with minimal flow where product or water can stagnate, promoting microbial growth

Q13. What is the main function of laminar airflow benches in aseptic processing areas?

• To provide turbulent mixing to dilute contaminants
• To supply unidirectional, particle-free air that sweeps particulates away from critical zones
• To increase room humidity for personnel comfort
• To provide heating for process equipment

Correct Answer: To supply unidirectional, particle-free air that sweeps particulates away from critical zones

Q14. Why is segregation of utilities (e.g., potable, purified, WFI) and process streams important in pharmaceutical facilities?

• To simplify inventory management of piping components
• To prevent cross-contamination and ensure each service meets its own quality specification
• To increase the length of piping runs for aesthetic symmetry
• To reduce the need for valves and controls

Correct Answer: To prevent cross-contamination and ensure each service meets its own quality specification

Q15. Proper grounding and earthing of equipment in production areas are important principally to:

• Prevent unauthorized access to control systems
• Reduce static accumulation and protect personnel and sensitive electronic equipment
• Improve the taste of water for human consumption
• Increase air flow efficiency in HVAC ducts

Correct Answer: Reduce static accumulation and protect personnel and sensitive electronic equipment

Q16. Which layout consideration improves maintenance access while minimizing contamination risk?

• Placing equipment tightly together to save space
• Providing adequate clearance around equipment for maintenance and segregating maintenance aisles from clean pathways
• Locating maintenance areas inside primary aseptic zones
• Removing access panels to simplify cleaning

Correct Answer: Providing adequate clearance around equipment for maintenance and segregating maintenance aisles from clean pathways

Q17. Which inert gas is most commonly used for blanketing or inerting reactors and storage vessels in pharmaceutical manufacturing?

• Oxygen
• Nitrogen
• Chlorine
• Hydrogen

Correct Answer: Nitrogen

Q18. The role of a point-of-use (final) filter on a water or WFI line is to:

• Heat the water to the required process temperature
• Provide the final barrier against particulates and microorganisms immediately before use
• Reduce the flow rate to match equipment demand
• Change the chemical composition of the water

Correct Answer: Provide the final barrier against particulates and microorganisms immediately before use

Q19. Which components are typically found in an Air Handling Unit (AHU) serving a cleanroom?

• HEPA filter, fan, pre-filters, cooling/heating coil, humidifier
• Autoclave, filter dryer, vacuum pump
• Only fans and lights
• Raw material feeders and packaging machines

Correct Answer: HEPA filter, fan, pre-filters, cooling/heating coil, humidifier

Q20. Routine monitoring of critical utilities (e.g., WFI microbial counts, HVAC differential pressure) is primarily intended to:

• Increase laboratory workload without operational benefit
• Detect deviations or trends early so corrective actions can maintain system control and product quality
• Replace the need for periodic maintenance
• Document operator productivity only

Correct Answer: Detect deviations or trends early so corrective actions can maintain system control and product quality

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