Concept and importance of pilot plant and scale-up techniques MCQs With Answer

Concept and importance of pilot plant and scale-up techniques MCQs With Answer

by

Pilot plant and scale-up techniques are essential in pharmaceutical manufacturing, linking bench-top research to commercial production. For B.Pharm students, mastering pilot-scale design, process development, formulation transfer, and scale-up strategies ensures consistent drug quality, safety, and regulatory compliance. Important keywords include pilot plant, scale-up techniques, process optimization, process validation, mixing, heat and mass transfer, residence time, geometric similarity, power per volume, PAT, DOE, and technology transfer. Understanding scale-dependent challenges—API stability, segregation, fouling, sterility—and using appropriate scale-up rules helps prevent failures and accelerates commercialization. This focused MCQ set explores theory, practical methods, troubleshooting and regulatory aspects of scale-up for pharmaceutical applications. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a pilot plant in pharmaceutical development?

  • To manufacture full-scale commercial batches for distribution
  • To validate laboratory findings and optimize processes before full-scale production
  • To replace laboratory research entirely
  • To perform only stability studies

Correct Answer: To validate laboratory findings and optimize processes before full-scale production

Q2. Which dimensionless number is most relevant when scaling mixing based on inertia and gravity effects in agitated vessels?

  • Reynolds number (Re)
  • Froude number (Fr)
  • Péclet number (Pe)
  • Schmidt number (Sc)

Correct Answer: Froude number (Fr)

Q3. Which scale-up rule maintains constant agitation energy per unit volume?

  • Constant tip speed
  • Constant Reynolds number
  • Constant power per volume (P/V)
  • Geometric similarity

Correct Answer: Constant power per volume (P/V)

Q4. In scale-up, maintaining geometric similarity means:

  • Keeping all linear dimensions proportional between scales
  • Using the same motor power at all scales
  • Maintaining identical temperatures only
  • Changing impeller types between scales

Correct Answer: Keeping all linear dimensions proportional between scales

Q5. Which process parameter is most critical for biochemical reactions sensitive to oxygen transfer?

  • Residence time distribution
  • kLa (volumetric mass transfer coefficient)
  • pH only
  • Particle size distribution

Correct Answer: kLa (volumetric mass transfer coefficient)

Q6. A common cause of scale-up failure for granulation is:

  • Identical binder spray patterns at all scales
  • Neglecting changes in shear and granule growth dynamics
  • Using the same batch size as laboratory trials
  • Overestimating API potency

Correct Answer: Neglecting changes in shear and granule growth dynamics

Q7. Which regulatory guidance outlines pharmaceutical quality systems and technology transfer expectations relevant to scale-up?

  • ICH Q8, Q9, Q10
  • ISO 9001 only
  • OSHA guidelines
  • ICH Q3A only

Correct Answer: ICH Q8, Q9, Q10

Q8. When scaling a heat-sensitive formulation, the most important scale-up consideration is:

  • Maximizing residence time to achieve slower processing
  • Minimizing heat flux and local hot spots to prevent degradation
  • Using higher temperature to speed up reactions
  • Ignoring heat transfer coefficients

Correct Answer: Minimizing heat flux and local hot spots to prevent degradation

Q9. Which technique helps identify critical process parameters (CPPs) during scale-up?

  • Design of Experiments (DOE)
  • Visual inspection only
  • Random trial-and-error
  • Increasing batch size without analysis

Correct Answer: Design of Experiments (DOE)

Q10. For scaling continuous processes, which factor is most important to maintain product quality?

  • Keeping batch sizes identical
  • Maintaining steady-state conditions and critical flow rates
  • Using batch operation parameters without modification
  • Eliminating in-line sensors

Correct Answer: Maintaining steady-state conditions and critical flow rates

Q11. Which scale-up metric is commonly used for stirred tanks to relate power input to mixing?

  • Specific surface area
  • Power number (Np) and power per volume (P/V)
  • Thermal conductivity only
  • pH gradient

Correct Answer: Power number (Np) and power per volume (P/V)

Q12. What does PAT (Process Analytical Technology) provide during scale-up?

  • Increased regulatory paperwork only
  • Real-time monitoring and control of CQAs/CPTs
  • Replacement for process validation
  • Primary packaging solutions

Correct Answer: Real-time monitoring and control of CQAs/CPTs

Q13. Which residence time distribution (RTD) behavior indicates poor mixing and potential scale-up issues?

  • Narrow, symmetric RTD
  • Broad RTD with long tails and dead zones
  • Perfect plug flow
  • Uniform instantaneous mixing

Correct Answer: Broad RTD with long tails and dead zones

Q14. When scaling a reactor for an exothermic API synthesis, the primary engineering concern is:

  • Color matching of the product
  • Removing reaction heat effectively to avoid runaway
  • Using a smaller impeller
  • Reducing solvent quality

Correct Answer: Removing reaction heat effectively to avoid runaway

Q15. Which scale-up approach aims to keep fluid dynamic similarity by matching Reynolds number?

  • Chemical similarity scaling
  • Hydrodynamic similarity scaling
  • Empirical fixed power scaling
  • Thermal similarity only

Correct Answer: Hydrodynamic similarity scaling

Q16. Technology transfer documents from R&D to manufacturing typically include:

  • Only the final market label
  • Process flow diagrams, critical parameters, validation protocols and analytical methods
  • Vendor marketing brochures
  • Only cost estimates

Correct Answer: Process flow diagrams, critical parameters, validation protocols and analytical methods

Q17. Which factor often changes when moving from lab mixers to pilot-scale mixers causing different shear rates?

  • Chemical formula of solvents
  • Impeller diameter-to-tank diameter ratio and tip speed
  • Active pharmaceutical ingredient (API) molecular weight only
  • Lot numbering system

Correct Answer: Impeller diameter-to-tank diameter ratio and tip speed

Q18. In scale-up of drying operations, which property strongly affects drying time and scale performance?

  • Tablet color
  • Bed fluidization and surface area-to-volume ratio
  • Company logo on equipment
  • Frequency of operator breaks

Correct Answer: Bed fluidization and surface area-to-volume ratio

Q19. Which of the following best describes ‘scale-up by similarity’?

  • Using identical process times only
  • Matching relevant dimensionless groups (e.g., Re, Fr, kLa) between scales
  • Only increasing batch volume without changes
  • Changing formulations for larger scale

Correct Answer: Matching relevant dimensionless groups (e.g., Re, Fr, kLa) between scales

Q20. Which risk assessment tool is commonly used to evaluate scale-up risks and prioritize mitigation?

  • FMEA (Failure Mode and Effects Analysis)
  • Gantt chart
  • SWOT analysis only
  • Random sampling

Correct Answer: FMEA (Failure Mode and Effects Analysis)

Q21. During scale-up, segregation risk increases primarily because:

  • Smaller equipment always mixes better
  • Particle size distribution and handling dynamics change with scale
  • APIs become chemically different
  • Regulatory demands decrease

Correct Answer: Particle size distribution and handling dynamics change with scale

Q22. Which phenomenon becomes more significant at larger scales and can affect heat transfer efficiency?

  • Enhanced molecular diffusion
  • Reduced surface area-to-volume ratio and increased thermal gradients
  • Lower boiling point of solvents
  • Instantaneous temperature equilibration

Correct Answer: Reduced surface area-to-volume ratio and increased thermal gradients

Q23. How does power per unit volume (P/V) typically change when scaling up with geometric similarity but constant tip speed?

  • P/V remains constant
  • P/V typically decreases as volume increases
  • P/V increases proportionally with volume
  • P/V becomes infinite

Correct Answer: P/V typically decreases as volume increases

Q24. Validation activities at pilot scale are important because they:

  • Are optional before commercial production
  • Demonstrate reproducibility and support parameters for full-scale validation
  • Only focus on labeling and packaging
  • Replace the need for commercial validation

Correct Answer: Demonstrate reproducibility and support parameters for full-scale validation

Q25. Which analytical approach helps monitor critical quality attributes in-line during scale-up?

  • Off-line HPLC sampling only
  • In-line Near Infrared (NIR) spectroscopy or Raman spectroscopy
  • Visual color comparison
  • Manual pH strip testing only

Correct Answer: In-line Near Infrared (NIR) spectroscopy or Raman spectroscopy

Q26. When scaling up a filtration step, the most critical consideration is:

  • Matching filter cake color
  • Maintaining flux, cake compressibility and transmembrane pressure behavior
  • Using a completely different solvent
  • Ignoring solids loading

Correct Answer: Maintaining flux, cake compressibility and transmembrane pressure behavior

Q27. Which of the following is a typical pilot plant deliverable during technology transfer?

  • Unvalidated production runs for sale
  • Scale-up report with critical parameters, ranges and justification
  • Only raw material purchase orders
  • Marketing plan only

Correct Answer: Scale-up report with critical parameters, ranges and justification

Q28. In an agitated tank, switching from laminar to turbulent flow during scale-up affects:

  • Only the color of the mixture
  • Mixing time, mass transfer rates and shear experienced by solids
  • Expiry date of product
  • None of the process variables

Correct Answer: Mixing time, mass transfer rates and shear experienced by solids

Q29. Which is a common method to scale up heat exchangers for improved heat removal?

  • Reducing heat transfer area
  • Increasing surface area or improving overall heat transfer coefficient (U)
  • Lowering coolant flow rates intentionally
  • Eliminating baffles

Correct Answer: Increasing surface area or improving overall heat transfer coefficient (U)

Q30. A successful scale-up program must integrate which disciplines to ensure robust commercialization?

  • Only chemistry and marketing
  • Process engineering, formulation science, quality, analytical development and regulatory affairs
  • Only finance and legal
  • Customer service exclusively

Correct Answer: Process engineering, formulation science, quality, analytical development and regulatory affairs

Leave a Comment