Containers and closures – types and performance MCQs With Answer

Introduction:

This quiz collection on “Containers and closures – types and performance” is designed for M.Pharm students specializing in Pharmaceutical Manufacturing Technology. It covers the materials, designs, and performance attributes of primary packaging systems used for sterile and non-sterile pharmaceuticals. Emphasis is placed on container-closure integrity, compatibility (extractables and leachables), barrier properties, sterilization compatibility, and common physical and analytical tests used to validate closures and containers. The questions are crafted to deepen understanding of practical selection criteria, regulatory expectations, and failure mechanisms relevant to product stability and patient safety, preparing students for advanced study and industry practice.

Q1. Which glass type is preferred for parenteral drug products due to its high chemical resistance and low alkali content?

• Type III glass
• Borosilicate (Type I) glass
• Soda-lime glass
• Lead glass

Correct Answer: Borosilicate (Type I) glass

Q2. Which polymer is most commonly chosen for prefillable syringes because of low extractables and good dimensional stability?

• Polyethylene terephthalate (PET)
• Polypropylene (PP)
• Cyclic olefin polymer (COP/COC)
• Polyvinyl chloride (PVC)

Correct Answer: Cyclic olefin polymer (COP/COC)

Q3. Which elastomeric material is typically preferred for injectable stoppers because of superior oxygen and moisture barrier and low permeability?

• Natural rubber
• Bromobutyl rubber
• Silicone rubber (uncoated)
• EPDM

Correct Answer: Bromobutyl rubber

Q4. Which closure coating is used to minimize interaction between drug product and elastomer by creating a fluoropolymer barrier?

• Polyisoprene coating
• Fluoropolymer (e.g., fluorocarbon/polymer) coating
• Polyurethane coating
• Hydroxypropyl cellulose coating

Correct Answer: Fluoropolymer (e.g., fluorocarbon/polymer) coating

Q5. Which test is considered a non-destructive method for container-closure integrity (CCI) that detects extremely small leaks using inert gas?

• Dye ingress test
• Vacuum decay
• Helium leak detection
• Microbial ingress challenge

Correct Answer: Helium leak detection

Q6. Which of the following is the primary purpose of siliconization of syringe barrels or stoppers?

• Improve moisture barrier properties
• Reduce particle generation and improve plunger gliding
• Increase oxygen permeability
• Provide antimicrobial activity

Correct Answer: Reduce particle generation and improve plunger gliding

Q7. In selection of a closure for lyophilized products, which property of the stopper is most critical to ensure proper seal during stoppering under vacuum?

• Color and aesthetics
• Permanent compression set and resilience
• Thermal conductivity
• Transparency

Correct Answer: Permanent compression set and resilience

Q8. Which regulatory monograph specifically provides test requirements for elastomeric closures intended for injections?

• USP <381> Elastomeric Closures for Injections
• EP Chapter 3.2.9
• ICH Q1A
• ISO 9001

Correct Answer: USP <381> Elastomeric Closures for Injections

Q9. Which performance attribute is primarily quantified by oxygen transmission rate (OTR) in packaging materials?

• Heat resistance
• Oxygen barrier performance
• Mechanical strength
• Optical clarity

Correct Answer: Oxygen barrier performance

Q10. Which container-closure system risk is most directly assessed by extractables and leachables (E&L) studies?

• Mechanical breakage risk during transport
• Migratory chemical contamination from packaging into drug product
• Microbial ingress during storage
• Headspace gas composition stability

Correct Answer: Migratory chemical contamination from packaging into drug product

Q11. Which sealing method is commonly used for glass vials containing vaccines and involves a metal ring to secure the stopper?

• Screw cap
• Crimped aluminum seal
• Heat induction seal
• Snap-fit cap

Correct Answer: Crimped aluminum seal

Q12. Which test is most suitable for detecting gross container leaks and major breaches in seal quality in a batch release context?

• High-performance liquid chromatography (HPLC)
• Dye ingress test
• Fourier-transform infrared spectroscopy
• OTR measurement

Correct Answer: Dye ingress test

Q13. For biologic parenterals sensitive to silicone oil, which stopper modification can reduce particulate and protein aggregation issues?

• Increased natural rubber content
• Fluoropolymer-laminated or coated stoppers
• Higher siliconization levels
• Use of chlorinated polyethylene

Correct Answer: Fluoropolymer-laminated or coated stoppers

Q14. Which polymer container demonstrates superior moisture barrier compared with conventional plastics and is often used for high-stability oral solids?

• Low-density polyethylene (LDPE)
• Polypropylene (PP)
• Polyethylene terephthalate (PET)
• Cyclic olefin copolymer (COC)

Correct Answer: Cyclic olefin copolymer (COC)

Q15. Which environmental parameter is directly controlled by closure permeability and influences long-term stability of hygroscopic drugs?

• Light exposure
• Relative humidity within headspace
• Magnetic field exposure
• Ambient temperature fluctuations

Correct Answer: Relative humidity within headspace

Q16. Which of the following is a destructive CCI test that measures change in internal pressure under liquid contact after vacuum application?

• Headspace gas analysis
• Vacuum decay (destructive variant)
• Mass spectrometry for extracts
• Optical microscopy

Correct Answer: Vacuum decay (destructive variant)

Q17. When evaluating particle contamination from closures, which technique is commonly used to quantify sub-visible particles in solution?

• Particle counting by light obscuration
• pH titration
• Karl Fischer titration
• UV-Vis spectroscopy

Correct Answer: Particle counting by light obscuration

Q18. Which property of a stopper is evaluated by a compression set test?

• Resistance to oxidation
• Ability to recover thickness after prolonged compression
• Color stability under light
• Permeability to volatile organics

Correct Answer: Ability to recover thickness after prolonged compression

Q19. For prefilled cartridges and syringes, which plunger characteristic is critical to minimize break-loose and glide forces variability?

• Bulk density of drug product
• Plunger elastomer formulation and lubrication/siliconization
• Label adhesion properties
• Crimping torque of cap

Correct Answer: Plunger elastomer formulation and lubrication/siliconization

Q20. Which closure failure mode is most likely to compromise sterility by allowing microbial ingress during storage?

• Excessive siliconization leading to improved glide
• Loss of seal integrity resulting in microchannels or leaks
• High barrier performance to oxygen
• Use of low-extractable materials

Correct Answer: Loss of seal integrity resulting in microchannels or leaks

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