This MCQ set covers production facilities for parenteral manufacturing with emphasis on cleanroom design, HVAC, aseptic processing, sterilization, isolators, lyophilization, utilities (WFI), and quality control. Tailored for B.Pharm students, it links GMP, ISO cleanroom classifications, environmental monitoring, gowning practices, pressure differentials, HEPA filtration, unidirectional airflow, sterile filters, media fills, sterility assurance (SAL), depyrogenation, and validation. Questions probe both theoretical principles and practical facility operations, contamination control strategies, risk assessment, documentation, and regulatory compliance. Attempting these questions will improve your problem-solving and validation skills. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which ISO cleanroom classification is typically required at the critical fill zone for aseptic parenteral filling?
- ISO 8
- ISO 7
- ISO 5
- ISO 3
Correct Answer: ISO 5
Q2. What is the primary purpose of HEPA filters in parenteral manufacturing HVAC systems?
- Control room temperature
- Remove viable and non-viable particles from the supply air
- Eliminate chemical vapors
- Provide compressed air for instruments
Correct Answer: Remove viable and non-viable particles from the supply air
Q3. Which pore size is considered standard for sterilizing-grade membrane filtration of parenteral solutions?
- 0.45 µm
- 0.22 µm
- 1.2 µm
- 0.05 µm
Correct Answer: 0.22 µm
Q4. What does SAL 10^-6 represent in sterile manufacturing?
- Probability of one non-sterile unit in ten
- Sterility Assurance Level indicating one non-sterile unit in one million
- Number of microbial contaminants allowed per batch
- Air change rate per hour in cleanrooms
Correct Answer: Sterility Assurance Level indicating one non-sterile unit in one million
Q5. Which validation stage verifies that the installed equipment and systems meet design specifications?
- Performance Qualification (PQ)
- Operational Qualification (OQ)
- Installation Qualification (IQ)
- Process Validation (PV)
Correct Answer: Installation Qualification (IQ)
Q6. Media fill tests are used in parenteral facilities to evaluate:
- Chemical stability of formulations
- Aseptic process capability and operator technique
- Sterilizer temperature uniformity
- Filter bubble point integrity
Correct Answer: Aseptic process capability and operator technique
Q7. In a pressure cascade for sterile manufacturing, the pressure should be:
- Higher in less clean areas and lower in cleaner areas
- Equal across all adjacent rooms
- Higher in cleaner areas and lower in less clean areas
- Variable depending on outdoor weather
Correct Answer: Higher in cleaner areas and lower in less clean areas
Q8. Which method is most appropriate for depyrogenation of glass vials?
- Steam sterilization at 121°C
- Dry heat depyrogenation at high temperatures
- Filtration through 0.22 µm membrane
- Gamma irradiation at low dose
Correct Answer: Dry heat depyrogenation at high temperatures
Q9. What is the main advantage of using isolators for aseptic filling?
- Lower capital cost than cleanrooms
- Complete elimination of environmental monitoring
- Physical separation between operators and product to reduce contamination risk
- Reduction in water for injection consumption
Correct Answer: Physical separation between operators and product to reduce contamination risk
Q10. Which test is commonly used to assess the endotoxin level in parenteral products?
- Thioether test
- Limulus Amebocyte Lysate (LAL) test
- Gram staining
- ATP bioluminescence
Correct Answer: Limulus Amebocyte Lysate (LAL) test
Q11. What is the purpose of a bubble point test for sterilizing filters?
- Measure filter pore size distribution
- Determine the maximum pressure the filter can withstand
- Verify membrane integrity and absence of leaks after filtration
- Estimate microbial load upstream of the filter
Correct Answer: Verify membrane integrity and absence of leaks after filtration
Q12. Which of the following is a critical environmental monitoring method for viable airborne contamination?
- Particle counter measuring inert particles
- Active air sampling onto agar plates
- Surface ATP swab only
- Pressure differential logging
Correct Answer: Active air sampling onto agar plates
Q13. For terminal sterilization of a heat‑sensitive parenteral, which approach is most suitable?
- Autoclaving at 121°C
- Sterile filtration followed by aseptic filling
- Dry heat at 160°C
- Steam-in-place equipment sterilization
Correct Answer: Sterile filtration followed by aseptic filling
Q14. Which utility is essential and must meet pharmacopeial standards for parenteral production?
- Potable water
- Deionized water
- Water for Injection (WFI)
- Process cooling water
Correct Answer: Water for Injection (WFI)
Q15. During aseptic gowning, which of the following is the correct general principle?
- Gowning from contaminated to clean areas
- Don sterile gloves before entering the gowning room
- Perform hand hygiene before donning sterile gloves and gown
- Reuse gloves between batches to save time
Correct Answer: Perform hand hygiene before donning sterile gloves and gown
Q16. Which microbial limit test directly demonstrates absence of viable microorganisms in a parenteral batch?
- Endotoxin test
- Sterility test (e.g., membrane filtration or direct inoculation)
- Total organic carbon (TOC) test
- Particulate matter counting
Correct Answer: Sterility test (e.g., membrane filtration or direct inoculation)
Q17. What is the main role of a depyrogenation tunnel in vial processing?
- Sterilize the container by moist heat
- Remove pyrogens (endotoxins) by dry heat
- Apply silicon coating to the vial interior
- Inspect vials for cosmetic defects
Correct Answer: Remove pyrogens (endotoxins) by dry heat
Q18. Which document captures routine operation steps, in-process controls, and responsibilities in a parenteral facility?
- Master Validation Plan
- Standard Operating Procedure (SOP)
- Quality Risk Management Report
- Change Control Form
Correct Answer: Standard Operating Procedure (SOP)
Q19. What is the primary indicator that aseptic processing may be out of control during environmental monitoring?
- Stable HVAC performance logs
- Consistent particle counts within limits
- Repeated excursion of viable counts above action limits
- Low endotoxin values
Correct Answer: Repeated excursion of viable counts above action limits
Q20. Lyophilization (freeze‑drying) primarily removes solvent from parenteral formulations by:
- Evaporation under atmospheric pressure
- Boiling at high temperatures
- Sublimation under reduced pressure
- Absorption onto desiccants
Correct Answer: Sublimation under reduced pressure
Q21. What is a common alarm parameter monitored in sterile HVAC systems to ensure cleanroom integrity?
- Ambient office lighting levels
- Pressure differentials between zones
- Operator body temperature
- Number of open doors per shift
Correct Answer: Pressure differentials between zones
Q22. Which type of sampling is used to assess personnel aseptic technique by measuring contamination transfer to product contact surfaces?
- Settle plates only
- Glove fingertip sampling onto agar
- Passive particle counting
- Endotoxin sampling
Correct Answer: Glove fingertip sampling onto agar
Q23. Which cleaning agent characteristic is most important for routine disinfectant selection in sterile areas?
- High foaming capacity
- Broad-spectrum antimicrobial efficacy and material compatibility
- Bright color for visual identification
- Strong odor to ensure user awareness
Correct Answer: Broad-spectrum antimicrobial efficacy and material compatibility
Q24. Which operation is essential before starting an aseptic batch to demonstrate readiness of the facility and personnel?
- Raw material sensory evaluation
- Media fill (simulation) with growth medium
- Final product stability testing
- Packaging artwork approval
Correct Answer: Media fill (simulation) with growth medium
Q25. In a sterile filtration setup, a prefilter (e.g., 0.45 µm) is used mainly to:
- Sterilize the product in a single step
- Remove larger particulates and extend life of the sterilizing filter
- Eliminate endotoxins
- Measure product viscosity
Correct Answer: Remove larger particulates and extend life of the sterilizing filter
Q26. Which parameter is NOT typically part of performance qualification (PQ) for a lyophilizer?
- Uniformity of product residual moisture across shelves
- Reproducibility of cycle parameters under load
- Material compatibility of vial glass composition
- Temperature mapping and vacuum stability during cycle
Correct Answer: Material compatibility of vial glass composition
Q27. For sterile injectable products, particulate matter limits are most closely related to which regulatory concern?
- Microbial sterility assurance
- Patient safety due to potential emboli or immune reactions
- Color stability of the solution
- pH drift during storage
Correct Answer: Patient safety due to potential emboli or immune reactions
Q28. What is the primary reason to perform routine HEPA filter integrity testing in parenteral facilities?
- To ensure appropriate airflow temperature
- To verify filter efficiency and absence of leaks that could allow contamination
- To measure humidity removal capability
- To calibrate pressure sensors
Correct Answer: To verify filter efficiency and absence of leaks that could allow contamination
Q29. Which regulatory concept emphasizes identifying and controlling risks to product quality in sterile manufacturing?
- Good Laboratory Practice (GLP)
- Quality by Design (QbD) and Quality Risk Management (QRM)
- Patent protection strategies
- Market authorization submission
Correct Answer: Quality by Design (QbD) and Quality Risk Management (QRM)
Q30. Which action is a critical control during filling of a sterile parenteral to reduce contamination?
- Use of open trays for component transfer without control
- Minimizing exposure time of sterile components and using closed transfer/isolation techniques
- Allowing ungloved hands to handle stoppers to speed up the line
- Storing WFI at room temperature without monitoring
Correct Answer: Minimizing exposure time of sterile components and using closed transfer/isolation techniques
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