Industrial Hazards – Pharmaceutical MCQs With Answer

Introduction:

Industrial Hazards – Pharmaceutical MCQs With Answer is a focused quiz collection designed for M.Pharm students preparing for the MIP 202T – Scale Up & Technology Transfer course. This set of multiple-choice questions emphasizes practical and theoretical aspects of industrial hazards encountered during pharmaceutical scale-up and technology transfer: chemical, physical, biological, ergonomic and process safety risks. Questions cover hazard identification, evaluation, control strategies, regulatory frameworks, and incident prevention measures such as HAZOP, LOPA, COSHH and GHS. Use these MCQs to consolidate knowledge, prepare for exams, and develop decision-making skills essential for ensuring safe, compliant and robust manufacturing during scale-up activities.

Q1. Which scenario best describes the primary cause of a dust explosion in a pharmaceutical manufacturing area?

• Accumulation of combustible dust in a confined space combined with an ignition source
• High direct sunlight exposure on powder bags
• Slow settling of coarse granules on open shelving
• Condensation forming on metal surfaces during cleaning

Correct Answer: Accumulation of combustible dust in a confined space combined with an ignition source

Q2. What is the main objective of a HAZOP study during process scale-up?

• To systematically identify potential deviations from design intent and associated hazards using guidewords
• To perform routine maintenance on laboratory instruments
• To validate cleaning procedures for production equipment
• To estimate commercial sales for the product after scale-up

Correct Answer: To systematically identify potential deviations from design intent and associated hazards using guidewords

Q3. Which statement correctly defines the Lower Explosive Limit (LEL)?

• The minimum concentration of a vapor in air below which propagation of a flame will not occur
• The maximum safe concentration of a toxic gas for workers
• The maximum concentration of vapor in air above which it will not ignite
• The temperature at which a liquid starts to boil under atmospheric pressure

Correct Answer: The minimum concentration of a vapor in air below which propagation of a flame will not occur

Q4. What is the autoignition temperature of a chemical?

• The temperature at which the chemical ignites spontaneously without an external ignition source
• The temperature at which the chemical releases toxic vapors
• The temperature at which the chemical melts
• The temperature at which the chemical reaches its flash point

Correct Answer: The temperature at which the chemical ignites spontaneously without an external ignition source

Q5. Which factor most commonly initiates a thermal runaway during scale-up of an exothermic reaction?

• Insufficient heat removal capacity relative to reaction heat generation
• Excessive stirring speed causing product degradation
• Using a lower grade of catalyst
• Deliberate dilution of reactants to reduce concentration

Correct Answer: Insufficient heat removal capacity relative to reaction heat generation

Q6. In the NFPA 704 diamond, what does the blue quadrant indicate?

• Health hazard severity
• Flammability
• Reactivity
• Special hazards such as oxidizer

Correct Answer: Health hazard severity

Q7. How many sections are required in a modern GHS-compliant Safety Data Sheet (SDS)?

• 16
• 10
• 8
• 24

Correct Answer: 16

Q8. What does a Time-Weighted Average (TWA) occupational exposure limit usually represent?

• The average concentration of a substance a worker can be exposed to over a standard 8-hour workday
• The maximum instantaneous concentration allowed for a short task
• The concentration that causes immediate death
• The average concentration over a 30-day period

Correct Answer: The average concentration of a substance a worker can be exposed to over a standard 8-hour workday

Q9. What is the correct order of the hierarchy of controls for managing workplace hazards?

• Elimination, Substitution, Engineering controls, Administrative controls, PPE
• PPE, Administrative controls, Engineering controls, Substitution, Elimination
• Administrative controls, Engineering controls, PPE, Substitution, Elimination
• Substitution, Elimination, PPE, Engineering controls, Administrative controls

Correct Answer: Elimination, Substitution, Engineering controls, Administrative controls, PPE

Q10. Why is nitrogen blanketing considered an asphyxiation hazard in confined spaces?

• Nitrogen displaces oxygen, reducing breathable oxygen concentration
• Nitrogen reacts violently with organic solvents
• Nitrogen forms explosive peroxides with air
• Nitrogen increases humidity leading to corrosion

Correct Answer: Nitrogen displaces oxygen, reducing breathable oxygen concentration

Q11. Which explosion protection strategy provides a direct pressure relief path to the atmosphere from a vessel?

• Explosion venting
• Explosion suppression via inerting
• Use of spark detectors only
• Reducing process temperature below freezing

Correct Answer: Explosion venting

Q12. What does COSHH stand for in workplace safety regulations?

• Control of Substances Hazardous to Health
• Classification of Safety Hazards for Health
• Control of Safety Hazards in Healthcare
• Chemical Operations Safety and Hazard Handling

Correct Answer: Control of Substances Hazardous to Health

Q13. Which statement best distinguishes flash point from fire point of a solvent?

• Flash point is the lowest temperature at which vapour ignites briefly; fire point is where sustained burning occurs
• Flash point is higher than fire point
• Flash point refers to boiling; fire point refers to freezing
• Flash point is only relevant for solids; fire point only for liquids

Correct Answer: Flash point is the lowest temperature at which vapour ignites briefly; fire point is where sustained burning occurs

Q14. Which role is least likely to be a required member of a HAZOP team for a pharmaceutical scale-up study?

• Marketing manager with no technical input
• Process engineer familiar with the design
• Operations representative who runs the process
• Instrumentation/control engineer

Correct Answer: Marketing manager with no technical input

Q15. What is the primary purpose of Layer of Protection Analysis (LOPA) in process safety?

• To evaluate whether existing independent protection layers reduce risk to tolerable levels using semi-quantitative assessment
• To design aesthetic layouts for production facilities
• To perform routine environmental monitoring of effluents
• To assign personnel shifts for production runs

Correct Answer: To evaluate whether existing independent protection layers reduce risk to tolerable levels using semi-quantitative assessment

Q16. Which hazardous area zone describes continuous presence of an explosive gas atmosphere?

• Zone 0
• Zone 1
• Zone 2
• Zone 20

Correct Answer: Zone 0

Q17. At what workplace sound level (8‑hour TWA) do many regulations set the action level for hearing conservation?

• 85 dB(A)
• 70 dB(A)
• 95 dB(A)
• 100 dB(A)

Correct Answer: 85 dB(A)

Q18. Which rule is most appropriate for storing oxygen cylinders in a pharmaceutical facility?

• Store oxygen cylinders separately from flammable gases and combustible materials, or provide a 3 m separation or suitable barrier
• Store oxygen with combustible solvents to save space
• Keep oxygen cylinders under direct sunlight to prevent freezing
• Always store oxygen cylinders horizontally on shelving

Correct Answer: Store oxygen cylinders separately from flammable gases and combustible materials, or provide a 3 m separation or suitable barrier

Q19. Which measure is typically most effective for reducing solvent emissions and associated fire risk during scale-up?

• Implement a closed-loop solvent recovery system
• Rely solely on personal protective equipment
• Open-air venting to dilute emissions
• Store bulk solvent in low-capacity open drums on the shop floor

Correct Answer: Implement a closed-loop solvent recovery system

Q20. Which immediate engineering control is most effective to mitigate a developing thermal runaway in a stirred reactor?

• Activate redundant cooling/chiller and emergency quench system to remove heat rapidly
• Increase agitator speed to generate heat dissipation by friction
• Introduce more reactant to dilute the mixture
• Delay operator response until after the next shift

Correct Answer: Activate redundant cooling/chiller and emergency quench system to remove heat rapidly

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