Entrepreneurship, project selection and pilot plant scale-up for herbal extracts MCQs With Answer

Introduction: This quiz collection focuses on entrepreneurship, project selection, and pilot plant scale-up specifically for herbal extracts, tailored for M.Pharm students studying Industrial Pharmacognostical Technology (MPG 104T). It combines technical scale-up concepts—extraction kinetics, solvent selection, mass and heat transfer, equipment sizing—with business and regulatory aspects such as market assessment, techno-economic feasibility, CAPEX/OPEX estimation, quality systems, and regulatory compliance for herbal products. Each question is designed to test practical understanding useful for designing pilot plants, drafting project reports, and preparing for industry roles or startups in phytopharmaceuticals. Use these MCQs to assess readiness for real-world process development and entrepreneurship in herbal extraction technologies.

Q1. Which primary component should be evaluated first when conducting a techno-economic feasibility study for a herbal extract production project?

• Laboratory-scale extraction yield and consistency
• Availability and seasonal variability of raw herbal material
• Preferred packaging designs
• Branding and marketing strategy

Correct Answer: Availability and seasonal variability of raw herbal material

Q2. In selecting a project for herbal extract manufacturing, the term ‘market pull’ refers to:

• A regulatory mandate to produce a specific extract
• Customer demand driving product development
• A technology push from academic research
• Availability of low-cost raw materials

Correct Answer: Customer demand driving product development

Q3. For pilot plant scale-up of a solvent extraction process, which parameter is most critical to scale geometrically to maintain similar mass transfer?

• Impeller diameter to tank diameter ratio (D/T)
• Number of operators per shift
• Color of the vessel lining
• Supplier lead time for spare parts

Correct Answer: Impeller diameter to tank diameter ratio (D/T)

Q4. When moving from lab to pilot scale for solid-liquid extraction of plant material, the most direct effect of increasing particle size is:

• Increased extraction rate due to higher porosity
• Decreased solvent viscosity
• Reduced surface area leading to slower extraction kinetics
• Change in solvent polarity

Correct Answer: Reduced surface area leading to slower extraction kinetics

Q5. A key benefit of running pilot batches before full commercial production is:

• Elimination of all regulatory requirements
• Validation of process reproducibility and identification of scale-dependent problems
• Instant reduction of raw material cost
• Guarantee of market success

Correct Answer: Validation of process reproducibility and identification of scale-dependent problems

Q6. Which heat transfer concern becomes especially important when concentrating herbal extracts in large evaporators during scale-up?

• Electrical conductivity of the extract
• Fouling and reduced overall heat transfer coefficient
• Color of the extraction vessel
• Operator uniformity in tasting samples

Correct Answer: Fouling and reduced overall heat transfer coefficient

Q7. In pilot plant design for herbal extracts, the primary reason to include a solvent recovery system is:

• To enhance the color of the final product
• To reduce solvent consumption, lower operating cost and minimize environmental impact
• To increase raw material weight
• To speed up packaging operations

Correct Answer: To reduce solvent consumption, lower operating cost and minimize environmental impact

Q8. For regulatory compliance of herbal extracts produced at pilot scale, which document is essential to demonstrate process control and reproducibility?

• Design drawings of the marketing logo
• Batch manufacturing records and process validation reports
• Employee personal emails
• Supplier catalogs for office furniture

Correct Answer: Batch manufacturing records and process validation reports

Q9. When estimating CAPEX for a pilot plant, which cost element is most sensitive to increases in scale?

• Office stationery
• Major process equipment (reactors, evaporators, dryers)
• Number of cafeteria meals
• Promotional brochure printing

Correct Answer: Major process equipment (reactors, evaporators, dryers)

Q10. Which extraction solvent property is most important for efficient extraction of active phytoconstituents while ensuring regulatory acceptability?

• High color index
• Appropriate polarity and acceptable toxicity/residue profile
• Extremely high boiling point regardless of toxicity
• Odor intensity only

Correct Answer: Appropriate polarity and acceptable toxicity/residue profile

Q11. During pilot scale-up, what is the main purpose of conducting a scale-up mass balance?

• To calculate office electricity bills
• To verify material inputs and outputs, yields and identify losses at each unit step
• To design company stationery
• To determine staff vacation schedules

Correct Answer: To verify material inputs and outputs, yields and identify losses at each unit step

Q12. Which drying technique is most suitable to preserve heat-sensitive phytochemicals at pilot scale?

• High-temperature tray drying without control
• Freeze drying (lyophilization)
• Open-air sun drying in uncontrolled conditions
• Extended high-shear milling while hot

Correct Answer: Freeze drying (lyophilization)

Q13. For extraction process scale-up, using dimensionless numbers helps because they:

• Eliminate need for any engineering calculations
• Allow dynamic similarity between lab and pilot scales accounting for fluid flow and mass transfer
• Only apply to electrical systems
• Are irrelevant for herbal extracts

Correct Answer: Allow dynamic similarity between lab and pilot scales accounting for fluid flow and mass transfer

Q14. A project report for a new herbal extract plant should include which critical regulatory section for product approval?

• Detailed recipes for employee meals
• Quality specification, analytical methods, stability data and regulatory compliance plan
• List of local tourist attractions
• Designs of company T-shirts

Correct Answer: Quality specification, analytical methods, stability data and regulatory compliance plan

Q15. In pilot plant extraction, what is the likely effect of insufficient solvent-to-solid ratio compared to the lab-optimized ratio?

• Improved extraction completeness
• Lower extraction yield and possible incomplete mass transfer
• Instant sterilization of the product
• Elimination of need for downstream purification

Correct Answer: Lower extraction yield and possible incomplete mass transfer

Q16. Which economic metric best indicates how quickly initial project investment might be recovered for a herbal extract venture?

• Number of laboratory notebooks
• Payback period
• Color of packaging
• Employee headcount

Correct Answer: Payback period

Q17. For pilot plant safety, what is the primary concern when using flammable organic solvents at scale?

• Improper label design
• Ignition sources, solvent vapor accumulation and need for explosion-proof equipment
• Excess humidity only
• Low staff training costs

Correct Answer: Ignition sources, solvent vapor accumulation and need for explosion-proof equipment

Q18. Which approach is most appropriate when extrapolating extraction kinetics from bench to pilot scale?

• Assume identical time profiles regardless of geometry
• Use mechanistic models or dimensionless correlations to account for diffusional and convective effects
• Rely solely on vendor brochures
• Double all process times arbitrarily

Correct Answer: Use mechanistic models or dimensionless correlations to account for diffusional and convective effects

Q19. In project selection, the SWOT analysis component ‘Threats’ typically evaluates:

• Internal strengths such as skilled staff
• External challenges such as competitor entry, regulatory changes, and raw material scarcity
• Company logos
• Preferred supplier lunch menus

Correct Answer: External challenges such as competitor entry, regulatory changes, and raw material scarcity

Q20. A critical quality attribute (CQA) for a standardized herbal extract that must be monitored during scale-up is:

• Employee birthday dates
• Assay of bioactive marker compound and impurity profile
• Number of pages in the marketing brochure
• Office parking space dimensions

Correct Answer: Assay of bioactive marker compound and impurity profile

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