Pharmaceutical packaging materials MCQs With Answer

Pharmaceutical packaging materials MCQs With Answer

This blog presents a focused set of multiple-choice questions (MCQs) on pharmaceutical packaging materials with answers, specifically designed for M.Pharm students studying Product Development and Technology Transfer. The quiz covers primary and secondary packaging, barrier properties, glass and plastic types, closures, blister and strip packaging, extractables/leachables, sterilization effects, container–closure integrity and regulatory expectations. Each question emphasizes applied knowledge required for formulation development, stability assessment and quality control of packaging systems. Use these MCQs to test conceptual understanding, prepare for exams, and identify areas needing further study. Attempt them under exam conditions and review relevant pharmacopeial chapters for deeper comprehension.

Q1. Which type of glass is preferred for parenteral products due to its high chemical resistance and low solubility?

• Type III (soda-lime glass)
• Type II (treated soda-lime glass)
• Type I (borosilicate glass)
• Tempered glass

Correct Answer: Type I (borosilicate glass)

Q2. What is the correct definition of primary packaging in pharmaceuticals?

• Packaging that is used only for transportation and warehouse protection
• Packaging that provides promotional information and branding
• Packaging that is in immediate contact with the drug product
• Any secondary outer carton used for multiple units

Correct Answer: Packaging that is in immediate contact with the drug product

Q3. Which polymer is commonly used for excellent oxygen barrier when used as a thin layer in multilayer films?

• Polyethylene terephthalate (PET)
• Polyvinyl chloride (PVC)
• Ethylene vinyl alcohol (EVOH)
• Low density polyethylene (LDPE)

Correct Answer: Ethylene vinyl alcohol (EVOH)

Q4. Among common polyethylenes, which has the highest moisture vapor transmission rate (i.e., poorest moisture barrier)?

• High density polyethylene (HDPE)
• Low density polyethylene (LDPE)
• Polypropylene (PP)
• Polyethylene terephthalate (PET)

Correct Answer: Low density polyethylene (LDPE)

Q5. What is the primary function of induction sealing applied to plastic containers?

• To provide child-resistant closure
• To hermetically seal a foil liner to the container neck using electromagnetic induction
• To print batch information on the cap
• To chemically bond the cap to the bottle material

Correct Answer: To hermetically seal a foil liner to the container neck using electromagnetic induction

Q6. Which of the following container–closure integrity (CCI) test methods is considered the most sensitive for detecting very small leaks?

• Dye ingress test
• Vacuum decay test
• Helium leak detection
• Visual inspection under light

Correct Answer: Helium leak detection

Q7. Which material is most commonly thermoformed to produce blister cavities for unit-dose packaging of tablets?

• Polyvinyl chloride (PVC)
• Aluminum foil basic sheet (Alu/Alu)
• Cold-form aluminum foil
• Low density polyethylene (LDPE)

Correct Answer: Polyvinyl chloride (PVC)

Q8. For maximum protection against moisture ingress, which packaging material is most suitable as a continuous barrier layer?

• Polyethylene terephthalate (PET)
• Ethylene vinyl alcohol (EVOH)
• Aluminum foil
• Polyvinyl chloride (PVC)

Correct Answer: Aluminum foil

Q9. How are “leachables” differentiated from “extractables” in packaging studies?

• Leachables are compounds that are only theoretical and not measured
• Extractables are measured under exaggerated laboratory conditions; leachables are compounds actually found in the product under normal storage
• Extractables are only volatile compounds; leachables are non-volatile
• Leachables are intentionally added antioxidants; extractables are impurities

Correct Answer: Extractables are measured under exaggerated laboratory conditions; leachables are compounds actually found in the product under normal storage

Q10. What is the role of oxygen scavengers in pharmaceutical packaging?

• To adsorb moisture from the headspace
• To neutralize acidic degradation products
• To chemically remove residual or ingress oxygen from the package headspace
• To act as a desiccant for the entire package

Correct Answer: To chemically remove residual or ingress oxygen from the package headspace

Q11. Which is a likely effect of gamma irradiation on polymeric packaging materials?

• Uniform improvement in flexibility without chemical change
• Chain scission and embrittlement or crosslinking depending on polymer and dose
• No effect; gamma only sterilizes without affecting polymer structure
• Conversion of polymers into glass-like inorganic materials

Correct Answer: Chain scission and embrittlement or crosslinking depending on polymer and dose

Q12. The typical closure arrangement for sealed lyophilized vials intended for sterile parenteral use is:

• Plastic screw cap only
• Crimped aluminum cap over a rubber stopper
• Heat-sealed plastic film
• Snap-fit tamper-evident cap

Correct Answer: Crimped aluminum cap over a rubber stopper

Q13. PVdC (polyvinylidene chloride) coating on PVC blister films is primarily used to improve which performance attribute?

• Mechanical strength under freezing
• Moisture (water vapor) barrier and chemical resistance
• Optical transparency only
• Thermoformability at high temperature

Correct Answer: Moisture (water vapor) barrier and chemical resistance

Q14. Which blister format is referred to as “cold form” and is commonly used for high barrier requirements?

• PVC/PVdC thermoformed blister
• Polyethylene terephthalate (PET) blister
• Aluminum cold-form foil (Alu/Alu)
• Polypropylene (PP) blister

Correct Answer: Aluminum cold-form foil (Alu/Alu)

Q15. What is the principal function of desiccant sachets placed within secondary packaging?

• To absorb oxygen and volatile organics
• To maintain a sterile environment by releasing antimicrobials
• To adsorb and reduce moisture in the enclosed space
• To provide cushion and mechanical protection

Correct Answer: To adsorb and reduce moisture in the enclosed space

Q16. What is the main advantage of co-extrusion in manufacturing multilayer polymeric films?

• It allows single-layer films only, reducing complexity
• It enables combining different polymers into one film to impart distinct barrier and mechanical properties
• It guarantees absolute inertness against all drug products
• It eliminates the need for any adhesive tie-layers

Correct Answer: It enables combining different polymers into one film to impart distinct barrier and mechanical properties

Q17. Which statement correctly distinguishes tamper-evident from child-resistant packaging?

• Tamper-evident packaging prevents children from opening; child-resistant packaging shows visible tampering
• Tamper-evident packaging provides a visible indication of prior opening; child-resistant packaging is designed to be difficult for children to open
• Both terms mean the same and are interchangeable
• Child-resistant packaging always uses metal seals; tamper-evident always uses plastics

Correct Answer: Tamper-evident packaging provides a visible indication of prior opening; child-resistant packaging is designed to be difficult for children to open

Q18. Seal strength in heat-sealed flexible laminates primarily depends on which factors?

• Color of the outer print layer only
• Properties of the sealant layer and sealing temperature, time and pressure
• Thickness of the aluminum foil only
• Ambient relative humidity only

Correct Answer: Properties of the sealant layer and sealing temperature, time and pressure

Q19. Metallized plastic films are incorporated into packaging mainly to:

• Increase water solubility of the film
• Improve barrier to light and enhance gas and aroma barrier compared with unmetalized film
• Provide active antimicrobial action
• Make the film fully breathable to gases

Correct Answer: Improve barrier to light and enhance gas and aroma barrier compared with unmetalized film

Q20. Which USP chapter specifically addresses plastic packaging systems and their suitability for pharmaceutical use?

• USP <1207> Container Closure Integrity
• USP <659> Packaging and Storage Requirements
• USP <661> Plastic Packaging Systems and their Materials of Construction
• USP <71> Sterility Tests

Correct Answer: USP <661> Plastic Packaging Systems and their Materials of Construction

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