Environmental Control for Parenterals MCQs With Answer

Environmental Control for Parenterals MCQs With Answer

This quiz collection is designed for M.Pharm students studying MIP 203T – Pharmaceutical Production Technology. It focuses on environmental control principles essential for sterile parenteral manufacture, including cleanroom classification, airflow patterns, filtration, pressure cascades, monitoring techniques, gowning, and containment technologies such as RABS and isolators. Questions emphasize practical understanding—how to prevent particulate and microbial contamination, interpret monitoring data, and apply regulatory concepts. Each item tests both theoretical foundation and applied aspects encountered in aseptic processing and validation. Use these MCQs for self-assessment, classroom discussion, and exam preparation to strengthen your competency in environmental control for parenterals.

Q1. What is the primary objective of environmental control in parenteral manufacturing?

• Maintain product aesthetics and color
• Minimize microbial and particulate contamination of sterile products
• Reduce production energy costs
• Optimize batch record documentation

Correct Answer: Minimize microbial and particulate contamination of sterile products

Q2. Which cleanroom grade is defined for critical aseptic operations such as filling and is associated with the highest level of air cleanliness?

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

Correct Answer: Grade A

Q3. According to common regulatory mapping, which ISO 14644-1 class corresponds to EU GMP Grade A environments?

• ISO Class 7
• ISO Class 6
• ISO Class 5
• ISO Class 8

Correct Answer: ISO Class 5

Q4. What is the typical filtration efficiency claimed for a HEPA filter used in sterile manufacturing?

• 50% for particles ≥5.0 µm
• 95% for particles ≥1.0 µm
• 99.97% for particles ≥0.3 µm
• 100% for particles ≥0.1 µm

Correct Answer: 99.97% for particles ≥0.3 µm

Q5. What is the principal role of a coarse or pre-filter in an HVAC system for a sterile facility?

• Sterilize incoming air
• Remove very fine submicron particles before HEPA filtration
• Capture large particles and extend HEPA service life
• Regulate room temperature

Correct Answer: Capture large particles and extend HEPA service life

Q6. Which statement best describes laminar (unidirectional) airflow used in critical aseptic zones?

• Air moves in random swirling patterns to promote mixing
• Air flows in parallel, uniform velocity streams to sweep particles away
• Airflow alternates direction periodically
• Air is recirculated without filtration

Correct Answer: Air flows in parallel, uniform velocity streams to sweep particles away

Q7. What is a commonly recommended center-line air velocity for a vertical laminar flow hood used in aseptic filling?

• 0.02 m/s
• 0.45 m/s
• 3.0 m/s
• 10.0 m/s

Correct Answer: 0.45 m/s

Q8. What does a pressure cascade in a sterile facility aim to achieve?

• Create equal pressure in all rooms to save energy
• Maintain higher pressure in less clean areas to flush contaminants out
• Maintain progressively lower pressures from cleaner to less-clean areas to prevent ingress of contaminants
• Allow outside air to flow into critical zones

Correct Answer: Maintain progressively lower pressures from cleaner to less-clean areas to prevent ingress of contaminants

Q9. What is a commonly recommended minimum pressure differential between adjacent cleanroom grades to help prevent contamination ingress?

• 0.5 Pa
• 2 Pa
• 10–15 Pa
• 100 Pa

Correct Answer: 10–15 Pa

Q10. Which environmental monitoring method provides quantitative viable airborne microbial data by sampling a known volume of air?

• Settle plates exposed passively
• Contact plates on work surfaces
• Active air sampling using an impactor or slit-to-agar device
• Visual inspection

Correct Answer: Active air sampling using an impactor or slit-to-agar device

Q11. Which instrument is used to measure non-viable particles (size and count) in cleanrooms in real time?

• Particle counter
• Incubator
• Settle plate
• Contact plate

Correct Answer: Particle counter

Q12. What is the primary purpose of settle plates in environmental monitoring?

• To actively pull and quantify a known air volume
• To detect and estimate the rate of microbial deposition onto critical surfaces over time
• To measure particle size distribution
• To test HEPA filter efficiency

Correct Answer: To detect and estimate the rate of microbial deposition onto critical surfaces over time

Q13. What is the first step in the typical aseptic gowning sequence to minimize personnel-borne contamination?

• Put on sterile gloves
• Don the outer sterile gown
• Perform hand hygiene (washing and/or sanitizing)
• Enter the critical zone immediately

Correct Answer: Perform hand hygiene (washing and/or sanitizing)

Q14. Which wall and surface characteristic is preferred for cleanrooms to reduce contamination and facilitate cleaning?

• Porous and textured finishes
• Smooth, non-porous, and chemically resistant surfaces
• Unsealed painted drywall
• Open-grid ceilings

Correct Answer: Smooth, non-porous, and chemically resistant surfaces

Q15. How does an isolator differ from a restricted access barrier system (RABS) in sterile processing?

• Isolators provide full physical separation between operator and product; RABS provides limited physical barrier with possible openings
• RABS always offers better microbial control than isolators
• Isolators allow direct operator access without gloves
• RABS is the same as an open laminar flow hood

Correct Answer: Isolators provide full physical separation between operator and product; RABS provides limited physical barrier with possible openings

Q16. Which of the following parameters are typically included in an environmental monitoring program for parenteral production?

• Airborne particle counts
• Viable counts (air and surfaces)
• Temperature, humidity and differential pressure
• All of the above

Correct Answer: All of the above

Q17. Which particle size thresholds are commonly reported by cleanroom particle counters for pharmaceutical manufacturing?

• ≥0.01 µm and ≥0.02 µm
• ≥0.5 µm and ≥5.0 µm
• Only particles >100 µm
• Only biological cells

Correct Answer: ≥0.5 µm and ≥5.0 µm

Q18. For critical aseptic operations, which monitoring approach for non-viable particles is considered best practice during production?

• No monitoring during operations
• Intermittent visual checks only
• Continuous real-time particle monitoring with alarms plus periodic viable sampling
• Monthly particle counts only

Correct Answer: Continuous real-time particle monitoring with alarms plus periodic viable sampling

Q19. Which is generally the single most important source of contamination in an aseptic processing area?

• HVAC equipment
• Personnel
• Sterile filters
• Packaged raw materials

Correct Answer: Personnel

Q20. What is the main purpose of conducting HEPA filter integrity testing (e.g., aerosol challenge/leak test)?

• To sterilize the filter media
• To verify the airflow is laminar
• To detect leaks and confirm filter efficiency and integrity
• To measure room temperature distribution

Correct Answer: To detect leaks and confirm filter efficiency and integrity

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