Construction, plant layout and environmental control MCQs With Answer

Introduction

Construction, plant layout and environmental control are central to ensuring product quality and patient safety in pharmaceutical manufacturing. This quiz collection for M.Pharm students focuses on design principles, cleanroom classification, HVAC systems, contamination control, finishes and utilities that underpin Good Manufacturing Practices (GMP). Questions emphasize practical engineering controls—airflow patterns, pressure cascades, HEPA filtration, monitoring strategies, personnel and material flows, and containment for potent compounds—so students can critically evaluate and apply concepts during facility design, validation and operations. The set combines conceptual knowledge and applied details used in regulatory inspections and risk-based decision making relevant to QC & QA roles.

Q1. Which of the following materials is most suitable for manufacturing cleanroom walls in pharmaceutical sterile areas due to its seamless, non-porous and cleanable properties?

• Painted gypsum board
• Stainless steel panels
• High-pressure laminate (HPL) panels
• Epoxy-coated cementitious panels

Correct Answer: Epoxy-coated cementitious panels

Q2. What is the primary purpose of establishing a pressure cascade between adjacent cleanrooms?

• To control room temperature differentials
• To prevent particle migration from less clean to more clean areas
• To reduce energy consumption of HVAC systems
• To maintain relative humidity levels

Correct Answer: To prevent particle migration from less clean to more clean areas

Q3. HEPA filters are rated to remove a minimum of 99.97% of particles at which particle size, commonly referred to as the most penetrating particle size (MPPS)?

• 0.1 µm
• 0.3 µm
• 1.0 µm
• 5.0 µm

Correct Answer: 0.3 µm

Q4. Which cleanroom classification (as per ISO) is typically equivalent to a GMP Grade A zone used for aseptic critical operations?

• ISO 8
• ISO 7
• ISO 6
• ISO 5

Correct Answer: ISO 5

Q5. When designing personnel and material flow in a sterile manufacturing suite, which layout principle best reduces cross-contamination risk?

• Single central gowning room serving multiple flows
• Opposing personnel and material flow paths with intersecting routes
• Unidirectional (linear) flow from raw material to finished product
• Shared corridors for personnel and product movement

Correct Answer: Unidirectional (linear) flow from raw material to finished product

Q6. Which ventilation parameter is most directly increased to dilute airborne contaminants in an ISO 5 cleanroom used for aseptic processing?

• Supply air temperature
• Number of air changes per hour (ACH)
• Return air humidity
• Duct static pressure

Correct Answer: Number of air changes per hour (ACH)

Q7. For a laminar flow workbench used in aseptic operations, the recommended vertical unidirectional air velocity is generally around which value?

• 0.01–0.05 m/s
• 0.1–0.2 m/s
• 0.36–0.54 m/s
• 1.0–1.5 m/s

Correct Answer: 0.36–0.54 m/s

Q8. Which of the following is a primary difference between viable and non-viable environmental monitoring?

• Viable monitoring measures particle size; non-viable measures colony-forming units
• Viable monitoring detects microorganisms capable of growth; non-viable monitors inert particulate matter
• Viable monitoring uses light-scattering particle counters; non-viable uses culture plates exclusively
• Viable monitoring is performed continuously; non-viable only intermittently

Correct Answer: Viable monitoring detects microorganisms capable of growth; non-viable monitors inert particulate matter

Q9. In cleanroom design, coved floor-to-wall junctions are implemented primarily to:

• Enhance thermal insulation of walls
• Facilitate effective cleaning and eliminate sharp corners that trap contaminants
• Provide additional storage against the wall
• Reduce construction costs

Correct Answer: Facilitate effective cleaning and eliminate sharp corners that trap contaminants

Q10. Which HVAC component is essential to maintain differential pressures and remove airborne microbial contaminants before air enters critical zones?

• Cooling tower
• Mixing dampers
• HEPA filter bank within the Air Handling Unit (AHU)
• Boiler feed water tank

Correct Answer: HEPA filter bank within the Air Handling Unit (AHU)

Q11. Which layout design best supports containment and minimizes operator exposure when handling highly potent APIs?

• Open-plan layout with shared equipment
• Closed isolator or Restricted Access Barrier System (RABS) with separate service corridors
• Side-by-side benches in a common room
• Centralized weighing in general manufacturing area

Correct Answer: Closed isolator or Restricted Access Barrier System (RABS) with separate service corridors

Q12. According to GMP principles, which surface finish property is most important for ceilings, walls and floors in sterile areas?

• High porosity to allow moisture exchange
• Rough texture to hide minor damage
• Smooth, seamless, chemically resistant and cleanable surface
• Matte finish that absorbs disinfectants

Correct Answer: Smooth, seamless, chemically resistant and cleanable surface

Q13. Which monitoring method provides quantitative measurement of airborne non-viable particles in a cleanroom?

• Settle plates
• Active air sampling with impactor for viable counts
• Optical particle counter (light-scattering)
• Surface contact plates

Correct Answer: Optical particle counter (light-scattering)

Q14. In a multi-room sterile facility, the recommended minimum pressure differential between a cleaner room and an adjacent less clean corridor is typically in the range of:

• 0.1–0.5 Pa
• 1–3 Pa
• 5–15 Pa
• 50–100 Pa

Correct Answer: 5–15 Pa

Q15. Which layout strategy reduces cross-contamination risk during filling operations by minimizing transfers and doors between areas?

• Functional clustering with multiple transfers through intermediate rooms
• Linear (product flow) layout with minimal intersections and direct progression
• Randomized placement of equipment
• Shared multi-product lines in a common zone

Correct Answer: Linear (product flow) layout with minimal intersections and direct progression

Q16. Why are gowning rooms and airlocks important in cleanroom suites?

• They serve as storage for raw materials
• They provide a controlled transition that limits particle and microbial ingress from personnel
• They are used primarily to control temperature only
• They are optional areas that do not affect contamination control

Correct Answer: They provide a controlled transition that limits particle and microbial ingress from personnel

Q17. Which environmental control parameter is most critical to control for maintaining sterility of lyophilization operations?

• Room color scheme
• Relative humidity and cleanliness during loading/unloading
• Sound level in the chamber
• Number of fluorescent fixtures

Correct Answer: Relative humidity and cleanliness during loading/unloading

Q18. What is the main advantage of downward unidirectional airflow (laminar flow) in critical aseptic zones?

• It reduces energy consumption drastically
• It creates a controlled, particle-free zone by sweeping contaminants away from critical surfaces
• It increases relative humidity uniformly
• It is only aesthetic and has no contamination control benefit

Correct Answer: It creates a controlled, particle-free zone by sweeping contaminants away from critical surfaces

Q19. Which routine maintenance practice is essential to ensure continued performance of HEPA filters in a cleanroom AHU?

• Painting filter housings annually
• Periodic integrity testing (e.g., DOP/PAO challenge test) and scheduled replacements
• Wiping HEPA media with disinfectant while in service
• Bypassing filters during low occupancy to extend life

Correct Answer: Periodic integrity testing (e.g., DOP/PAO challenge test) and scheduled replacements

Q20. During design review for a sterile plant, a risk-based approach (e.g., FMEA) is used primarily to:

• Eliminate the need for environmental monitoring
• Identify and prioritize potential failure modes that could impact product quality and direct mitigation controls
• Determine staff salaries and shifts
• Replace physical containment with administrative controls only

Correct Answer: Identify and prioritize potential failure modes that could impact product quality and direct mitigation controls

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