Materials used for pharmaceutical packaging MCQs With Answer

Materials used for pharmaceutical packaging MCQs With Answer provides B. Pharm students a focused review of packaging materials essential for drug stability, safety, and regulatory compliance. This introduction covers key topics such as glass types (Type I/II/III), polymers (PVC, PET, HDPE, LDPE, PP), aluminum foil, laminates, barrier properties, moisture and oxygen permeability, extractables/leachables, sterilization compatibility, closures, and desiccants. Understanding compatibility, migration, light and moisture protection, and packaging integrity is critical for formulation and quality control. Clear knowledge of these materials supports appropriate selection for oral, parenteral, topical, and lyophilized products. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which glass type is preferred for parenteral products requiring high chemical resistance and low alkali release?

  • Soda-lime glass (Type III)
  • Borosilicate glass (Type I)
  • Tempered glass
  • Soft glass

Correct Answer: Borosilicate glass (Type I)

Q2. Which polymer is most commonly used for clear, rigid blister packs with good moisture barrier?

  • Polyvinyl chloride (PVC)
  • Polyethylene terephthalate (PET)
  • Low-density polyethylene (LDPE)
  • Polystyrene (PS)

Correct Answer: Polyethylene terephthalate (PET)

Q3. Which material provides the best oxygen barrier when used as a single foil layer in pharmaceutical packaging?

  • Polypropylene film
  • Aluminum foil
  • Polyethylene film
  • Cellulose acetate

Correct Answer: Aluminum foil

Q4. PVdC-coated PVC is used in blister packaging primarily to improve which property?

  • Thermal conductivity
  • Optical clarity
  • Moisture and oxygen barrier
  • Impact resistance

Correct Answer: Moisture and oxygen barrier

Q5. Which plasticizer class is frequently scrutinized due to migration concerns in pharmaceutical packaging?

  • Phthalates
  • Glycols
  • Esters of citric acid
  • Adipates

Correct Answer: Phthalates

Q6. For lyophilized (freeze-dried) drugs in vials, which stopper material is commonly used for low gas permeability and good compatibility?

  • Natural rubber
  • Bromobutyl rubber
  • Synthetic silicone foam
  • Chloroprene

Correct Answer: Bromobutyl rubber

Q7. Which property is described by Water Vapour Transmission Rate (WVTR) when evaluating packaging films?

  • Oxygen ingress over time
  • Resistance to puncture
  • Rate of moisture permeation
  • Light transmittance

Correct Answer: Rate of moisture permeation

Q8. Which sterilization method can cause polymer embrittlement or discoloration if not compatible?

  • Heat sealing at 120°C
  • Gamma irradiation
  • Cold water wash
  • Ultrasonic cleaning

Correct Answer: Gamma irradiation

Q9. Which packaging material is most appropriate for light-sensitive drugs to prevent photodegradation?

  • Clear PET bottle
  • Amber glass vial
  • Transparent PVC blister
  • White polyethylene bag

Correct Answer: Amber glass vial

Q10. Which of the following is a key reason to use aluminum foil laminate in sachets for hygroscopic drugs?

  • Increase product weight
  • Provide heat insulation
  • Provide excellent moisture and oxygen barrier
  • Improve biodegradability

Correct Answer: Provide excellent moisture and oxygen barrier

Q11. Which term describes chemical substances that can leach from packaging into the drug product?

  • Extractables and leachables
  • Adsorbates
  • Sorbents
  • Permeants

Correct Answer: Extractables and leachables

Q12. Which polymer is widely used for high chemical resistance and good barrier for oral liquid bottles?

  • Polypropylene (PP)
  • Polyethylene terephthalate (PET)
  • Polyvinyl chloride (PVC)
  • Polymethyl methacrylate (PMMA)

Correct Answer: Polyethylene terephthalate (PET)

Q13. Which closure feature is designed to show visible evidence of tampering?

  • Child-resistant cap
  • Tamper-evident seal
  • Screw thread
  • Flip-top lid

Correct Answer: Tamper-evident seal

Q14. Which parameter is most important when selecting packaging for hygroscopic powders?

  • Color of packaging
  • Mechanical strength only
  • Moisture barrier performance
  • Recyclability alone

Correct Answer: Moisture barrier performance

Q15. Which material is preferable for parenteral primary packaging when autoclave sterilization at high temperature is required?

  • LDPE syringe barrel
  • Borosilicate glass vial
  • PVC blister
  • Polystyrene ampoule

Correct Answer: Borosilicate glass vial

Q16. Which test evaluates a sealed package’s resistance to leakage under pressure or vacuum?

  • Peel strength test
  • Microbial challenge test
  • Package integrity/leak test (e.g., dye ingress, vacuum decay)
  • Tensile test

Correct Answer: Package integrity/leak test (e.g., dye ingress, vacuum decay)

Q17. Which plastic is commonly used for child-resistant pill bottles due to toughness and good sealability?

  • Polystyrene (PS)
  • High-density polyethylene (HDPE)
  • Polyvinyl chloride (PVC)
  • Polytetrafluoroethylene (PTFE)

Correct Answer: High-density polyethylene (HDPE)

Q18. Which coating on glass vials reduces breakage and surface flaws during handling?

  • Sodium carbonate wash
  • Silicone oil or polymeric external coating
  • Hydrochloric acid etch
  • Polyvinyl alcohol immersion

Correct Answer: Silicone oil or polymeric external coating

Q19. Which is a disadvantage of PVC as a primary packaging polymer for some pharmaceuticals?

  • Excellent moisture barrier
  • Potential for plasticizer migration and interaction
  • High heat resistance for sterilization
  • Inertness with all drug molecules

Correct Answer: Potential for plasticizer migration and interaction

Q20. Which component is added inside packaging to control humidity and protect moisture-sensitive products?

  • Oxygen scavenger sachet
  • Desiccant sachet
  • Anticaking agent
  • Light diffuser

Correct Answer: Desiccant sachet

Q21. Which packaging test measures oxygen ingress and is critical for oxidation-prone drugs?

  • Water vapour transmission rate (WVTR)
  • Oxygen transmission rate (OTR)
  • Peel adhesion test
  • Drop impact test

Correct Answer: Oxygen transmission rate (OTR)

Q22. For blister packs used in unit-dose cold chain vaccines, which property of the primary film is essential?

  • High thermal conductivity
  • Flexibility only
  • Low gas and moisture permeability and cold-temperature resilience
  • Translucent color

Correct Answer: Low gas and moisture permeability and cold-temperature resilience

Q23. Which laminated material often combines plastics and aluminum to deliver both strength and barrier in sachets?

  • Single-layer polyethylene
  • Paperboard only
  • Plastic-aluminum-plastic (PAP) laminates
  • Glass laminate

Correct Answer: Plastic-aluminum-plastic (PAP) laminates

Q24. Which factor must be considered to prevent adsorption of drug onto plastic containers?

  • Container color only
  • Surface area, chemical affinity, and drug lipophilicity
  • Only the package geometry
  • Only the closure type

Correct Answer: Surface area, chemical affinity, and drug lipophilicity

Q25. Which method is preferred for sterilizing heat-sensitive empty plastic syringes and some packaging components?

  • Autoclaving at 121°C
  • Ethylene oxide (EtO) sterilization
  • Boiling in water
  • Dry heat at 160°C

Correct Answer: Ethylene oxide (EtO) sterilization

Q26. Which packaging material is commonly used for topical creams and provides chemical resistance with good barrier properties?

  • Glass ampoules
  • Aluminum tubes with laminate
  • Cardboard cartons
  • Cellophane wraps

Correct Answer: Aluminum tubes with laminate

Q27. Which regulatory guidance focuses on evaluation of extractables and leachables from pharmaceutical packaging?

  • ICH Q1A (Stability)
  • USP <381> (Elastomeric closures) and ICH Q3A
  • FDA guidance and USP chapters on Extractables/Leachables
  • ISO 9001 only

Correct Answer: FDA guidance and USP chapters on Extractables/Leachables

Q28. Which packaging material is preferred for prefilled syringes to ensure clarity and dimensional stability?

  • Glass Type II
  • Polycarbonate or cyclic olefin polymer (COP/COC)
  • LDPE
  • Nonmedical cardboard

Correct Answer: Polycarbonate or cyclic olefin polymer (COP/COC)

Q29. Which term describes the uptake of drug molecules by packaging material, reducing dose availability?

  • Leaching
  • Sorption (adsorption/absorption)
  • Permeation enhancement
  • Desiccation

Correct Answer: Sorption (adsorption/absorption)

Q30. Which property of packaging is most critical for sterile injectable products to maintain sterility during storage and transport?

  • Visual aesthetics
  • Seal integrity and container closure system robustness
  • Cost alone
  • Marketing label design

Correct Answer: Seal integrity and container closure system robustness

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