Parenteral Facility Design MCQs With Answer

Introduction: This collection of Parenteral Facility Design MCQs With Answer is tailored for M.Pharm students studying MIP 203T – Pharmaceutical Production Technology. The set focuses on critical aspects of designing sterile parenteral manufacturing facilities: cleanroom classifications, HVAC and HEPA filtration principles, airflow patterns, pressure cascades, gowning and personnel flow, material/media transfer, utilities, environmental monitoring and validation. Questions emphasize regulatory expectations, contamination control strategies and practical design considerations for aseptic processing areas. Use these MCQs to reinforce conceptual understanding, identify gaps, and prepare for examinations and practical design tasks encountered in pharmaceutical production of parenteral dosage forms.

Q1. Which cleanroom grade is required for aseptic filling work zones where open sterile products are exposed to the environment?

• Grade A
• Grade B
• Grade C
• Grade D

Correct Answer: Grade A

Q2. What is the primary purpose of a pressure cascade in parenteral facility design?

• To maintain equal temperatures across zones
• To direct airflow from cleaner to less-clean areas and prevent contamination ingress
• To increase air change rates in all rooms
• To provide negative pressure in all production rooms

Correct Answer: To direct airflow from cleaner to less-clean areas and prevent contamination ingress

Q3. HEPA filters used in aseptic processing HVAC systems are typically rated to retain what minimum particle size efficiency?

• 95% at 0.3 μm
• 99.97% at 0.3 μm
• 99% at 1.0 μm
• 90% at 0.5 μm

Correct Answer: 99.97% at 0.3 μm

Q4. Which airflow pattern is preferred in a Grade A unidirectional flow hood to minimize particle contamination during filling?

• Horizontal unidirectional airflow from side-to-side
• Turbulent mixing airflow from ceiling and walls
• Vertical unidirectional (laminar) downward airflow
• Circular recirculating airflow at floor level

Correct Answer: Vertical unidirectional (laminar) downward airflow

Q5. What is the recommended approach for personnel movement between a Grade D corridor and a Grade B background area to minimize contamination risk?

• Move directly without stopping
• Use a designated gowning room with controlled gowning sequence and hand hygiene
• Wear shoe covers only
• Enter through any door available during low activity times

Correct Answer: Use a designated gowning room with controlled gowning sequence and hand hygiene

Q6. During qualification, which test verifies the integrity and proper installation of HEPA filters in a parenteral cleanroom?

• Smoke visualization test
• Particle count viability test
• PAO (or DOP) photometer challenge test for leak and efficiency
• Temperature mapping

Correct Answer: PAO (or DOP) photometer challenge test for leak and efficiency

Q7. Which environmental monitoring parameter is most critical to assess the risk of microbial contamination in Grade A work zones?

• Colony-forming units (CFU) from air and surface samples
• Room temperature variability
• Noise levels
• Light intensity

Correct Answer: Colony-forming units (CFU) from air and surface samples

Q8. For aseptic processing, what is the typical recommended minimum air change per hour (ACH) for a Grade B background area to maintain cleanliness?

• 2–6 ACH
• 10–25 ACH
• 50–150 ACH
• 500–1000 ACH

Correct Answer: 50–150 ACH

Q9. A pass-through hatch between a non-sterile corridor and a sterile buffer should be designed to:

• Allow simultaneous opening of both doors for convenience
• Have interlocking doors to prevent simultaneous opening and allow decontamination between transfers
• Be equipped with a window only
• Be unlocked at all times to speed up material flow

Correct Answer: Have interlocking doors to prevent simultaneous opening and allow decontamination between transfers

Q10. Which material of construction is preferred for walls and floors in aseptic suites to facilitate cleaning and minimize particulation?

• Porous ceramic tiles with grout
• Seamless, non-porous, easily cleanable surfaces such as coved vinyl or epoxy resin
• Unsealed concrete
• Textured wood paneling

Correct Answer: Seamless, non-porous, easily cleanable surfaces such as coved vinyl or epoxy resin

Q11. Which of the following best describes the correct gowning sequence for entering a Grade A/B zone from a gowning room?

• Gloves, mask, shoe covers, gown
• Mask, hair cover, shoes, gloves, gown
• Hand hygiene, shoe covers, gown, hood/face mask, sterile gloves in that order
• Gown, boots, gloves, leave mask until inside

Correct Answer: Hand hygiene, shoe covers, gown, hood/face mask, sterile gloves in that order

Q12. Which validation activity demonstrates that the parenteral facility maintains required cleanliness and pressure differentials during actual production operations?

• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)

Correct Answer: Performance qualification (PQ)

Q13. In parenteral facility design, what is the main benefit of segregating aseptic processing into defined zones (Grade A/B/C/D)?

• Reduce electrical consumption
• Control risk of cross-contamination and manage environmental quality by zoning with different controls
• Allow free movement of materials between zones
• Minimize staffing needs

Correct Answer: Control risk of cross-contamination and manage environmental quality by zoning with different controls

Q14. What is the recommended action if particle counts in a Grade A area exceed specified limits during a simulated media fill or routine monitoring?

• Ignore minor excursions
• Investigate root cause, stop production if required, carry out corrective actions and requalification
• Increase production speed to compensate
• Only document without further action

Correct Answer: Investigate root cause, stop production if required, carry out corrective actions and requalification

Q15. Which utility is most critical to ensure aseptic integrity of parenteral products and must be supplied as sterile or appropriately treated upstream?

• Compressed air for pneumatic tools without filtration
• Clean steam for sterilization of equipment and components
• Municipal potable water with no further treatment
• Untreated nitrogen

Correct Answer: Clean steam for sterilization of equipment and components

Q16. What is the preferred method to transfer sterile components into a Grade A/B zone without personnel entry to reduce contamination risk?

• Open the door for a worker to pass materials quickly
• Use a validated sterile transfer hatch/pass-through with interlocks and decontamination procedures
• Throw items through a window
• Carry items in from an adjacent non-controlled area

Correct Answer: Use a validated sterile transfer hatch/pass-through with interlocks and decontamination procedures

Q17. Which environmental parameter is most often controlled and monitored because it affects both product stability and personnel comfort in parenteral suites?

• Ambient noise
• Temperature and relative humidity
• Wall color
• Vibration

Correct Answer: Temperature and relative humidity

Q18. For equipment placement in an aseptic filling line, what design principle minimizes particle generation and facilitates cleaning?

• Cramped layout to save space
• Open, cleanable layouts with minimal ledges, accessible joints and smooth surfaces; maintain workflow from clean to less clean
• Place utilities on the floor between machines
• Stack equipment without service gaps

Correct Answer: Open, cleanable layouts with minimal ledges, accessible joints and smooth surfaces; maintain workflow from clean to less clean

Q19. Which of the following is a regulatory expectation regarding documentation of parenteral facility design and operation?

• No documentation is required if the facility is new
• Comprehensive design, validation, SOPs and change control records must be maintained and available for inspection
• Only personnel records are necessary
• Verbal approvals are sufficient for minor changes

Correct Answer: Comprehensive design, validation, SOPs and change control records must be maintained and available for inspection

Q20. What is the most appropriate method to control contamination risk from maintenance and contractors entering sterile areas?

• Allow unrestricted access during off-shifts
• Use strict access control, dedicated gowning, escorted entry, minimized tools, documented work procedures and post-maintenance validation/cleaning
• Allow them to enter without training to save time
• Only clean the area after they leave without documentation

Correct Answer: Use strict access control, dedicated gowning, escorted entry, minimized tools, documented work procedures and post-maintenance validation/cleaning

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