Quality control tests for packaging materials MCQs With Answer

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Quality control tests for packaging materials MCQs With Answer provide B.Pharm students a focused, practical overview of analytical and physical evaluations used to ensure drug product safety and stability. This introduction highlights essential concepts: packaging materials, container closure integrity, seal strength, water vapour transmission rate (WVTR), oxygen transmission rate (OTR), extractables and leachables, tensile and burst strength, barrier properties, migration testing, and pharmacopeial standards (IP, BP, USP). Understanding these tests helps in selecting appropriate primary and secondary packaging, validating packaging processes, and interpreting regulatory requirements. Clear knowledge of test methods, instrumentation, and typical failure modes is vital for quality assurance in pharmaceutical development.
Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does WVTR measure in packaging materials?

  • Amount of water absorbed by the material
  • Rate of water vapour transmission through the material
  • Moisture content of packaged product
  • Time to delamination under humidity

Correct Answer: Rate of water vapour transmission through the material

Q2. Which test is most appropriate to assess oxygen barrier properties of a polymer film?

  • Tensile strength test
  • Oxygen transmission rate (OTR) test
  • Peel strength test
  • Burst strength test

Correct Answer: Oxygen transmission rate (OTR) test

Q3. Container Closure Integrity Testing (CCIT) is performed to evaluate:

  • Visual appearance of the label
  • Drug potency over time
  • Maintenance of sterility and protection from ingress
  • Coating uniformity of tablets

Correct Answer: Maintenance of sterility and protection from ingress

Q4. Which CCIT method is non-destructive and commonly used for parenteral vials?

  • Dye ingress test
  • Helium leak detection
  • Vacuum thermal shock
  • Visual crack test

Correct Answer: Helium leak detection

Q5. Which test assesses the force required to open a blister pack?

  • Peel strength test
  • Compression set test
  • Water vapour transmission test
  • Oxygen permeation test

Correct Answer: Peel strength test

Q6. Extractables and leachables studies primarily address:

  • Mechanical durability of packaging
  • Chemical migration from packaging into the drug
  • Label adhesion under humid conditions
  • Optical clarity of primary containers

Correct Answer: Chemical migration from packaging into the drug

Q7. Which pharmacopeial test evaluates glass containers for resistance to water attack?

  • Hydrolytic resistance test
  • Drop impact test
  • Thermal shock test
  • Folding endurance test

Correct Answer: Hydrolytic resistance test

Q8. Seal integrity of flexible packaging is commonly assessed by:

  • Tensile testing of web material
  • Dye penetration or vacuum decay methods
  • Measuring grammage of paper
  • Determining colour fastness

Correct Answer: Dye penetration or vacuum decay methods

Q9. Which property is measured by burst strength testing?

  • Adhesive tackiness
  • Resistance to rupture under pressure
  • Rate of solvent evaporation
  • Electrostatic charge of the film

Correct Answer: Resistance to rupture under pressure

Q10. Migration testing for packaging materials is crucial because it:

  • Determines tensile modulus
  • Evaluates potential contaminant transfer to product
  • Measures gas permeability only
  • Assesses microbiological contamination exclusively

Correct Answer: Evaluates potential contaminant transfer to product

Q11. Which accelerated condition is commonly used for packaging stability testing?

  • 0°C and 10% RH
  • 25°C and 60% RH
  • 40°C and 75% RH
  • 100°C dry heat

Correct Answer: 40°C and 75% RH

Q12. Which instrument measures the thickness and uniformity of flexible films?

  • Micrometer or thickness gauge
  • Fourier-transform infrared (FTIR) spectrometer
  • Gas chromatograph
  • pH meter

Correct Answer: Micrometer or thickness gauge

Q13. Which test assesses the adhesive bond between label and container under stress?

  • Peel adhesion test
  • Water vapour permeability
  • OTR measurement
  • Colorimetry

Correct Answer: Peel adhesion test

Q14. Which is a common failure mode detected by container closure integrity testing?

  • UV absorption changes
  • Micro-leaks allowing microbial ingress
  • Decrease in melting point
  • Increase in tablet friability

Correct Answer: Micro-leaks allowing microbial ingress

Q15. What does the term “grammage” refer to in paperboard packaging?

  • Thickness in mm
  • Weight per unit area (g/m²)
  • Tensile strength in N
  • Porosity percentage

Correct Answer: Weight per unit area (g/m²)

Q16. In plastic packaging testing, the Melt Flow Index (MFI) indicates:

  • Barrier performance to oxygen
  • Flow properties and processability of the polymer
  • Surface roughness
  • Moisture absorption rate

Correct Answer: Flow properties and processability of the polymer

Q17. Which test is recommended to detect particulate contamination originating from packaging?

  • Visual appearance test only
  • Particle counting of the drug product after storage
  • OTR measurement
  • Label peel test

Correct Answer: Particle counting of the drug product after storage

Q18. Which international guideline is often referenced for testing extractables and leachables?

  • ICH Q1A
  • ICH Q3B
  • ICH Q3D and USP <1663>/<1664> guidance
  • ICH Q5C

Correct Answer: ICH Q3D and USP <1663>/<1664> guidance

Q19. Which mechanical test helps determine the flexibility and elongation of a film?

  • Tensile elongation test
  • Hydrolytic resistance
  • Water penetration test
  • Optical density measurement

Correct Answer: Tensile elongation test

Q20. Microbial ingress testing of sterile packaging primarily evaluates:

  • Chemical migration to the product
  • Shelf-life related colour changes
  • Ability to prevent microbial contamination under stress
  • Mechanical puncture resistance only

Correct Answer: Ability to prevent microbial contamination under stress

Q21. What is the main purpose of accelerated ageing of packaged drug products?

  • To sterilize the packaging
  • To simulate long-term storage and predict shelf life
  • To measure label adhesion at high temperatures
  • To determine polymer melt index

Correct Answer: To simulate long-term storage and predict shelf life

Q22. Which test is typically used to evaluate headspace gas composition in sealed vials?

  • Gas chromatography or mass spectrometry
  • UV-Vis spectroscopy
  • pH titration
  • Viscometry

Correct Answer: Gas chromatography or mass spectrometry

Q23. Which property is critical for packaging of photosensitive drugs?

  • Thermal conductivity
  • Light transmission or UV barrier property
  • Electrical insulation
  • Magnetic susceptibility

Correct Answer: Light transmission or UV barrier property

Q24. For aluminium foil laminated films, which test checks adhesion between layers?

  • Layer delamination and peel test
  • OTR test
  • Moisture sorption isotherm
  • Color fastness test

Correct Answer: Layer delamination and peel test

Q25. Which regulatory requirement emphasizes that packaging must not interact adversely with drug products?

  • Good Laboratory Practice (GLP)
  • Good Distribution Practice (GDP)
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)

Correct Answer: Good Manufacturing Practice (GMP)

Q26. In dye ingress testing, what does penetration of dye indicate?

  • Improved barrier function
  • Presence of leak or compromised seal
  • Lower oxygen permeability
  • Higher tensile strength

Correct Answer: Presence of leak or compromised seal

Q27. Which test assesses the puncture resistance of sterile primary containers?

  • Puncture or puncture resistance test
  • OTR measurement
  • Peel adhesion test
  • Hydrolytic resistance only

Correct Answer: Puncture or puncture resistance test

Q28. Photostability testing of the packaged product assesses:

  • Mechanical strength of bottle caps
  • Effect of light exposure on drug potency and packaging
  • Water vapour transmission at 100% RH
  • Melt flow index under light

Correct Answer: Effect of light exposure on drug potency and packaging

Q29. Which parameter is directly related to the ability of packaging to resist grease and oil?

  • Grease resistance or Kit test
  • OTR
  • pH of the packaging
  • Glass transition temperature

Correct Answer: Grease resistance or Kit test

Q30. Sampling plans for packaging QC are important because they:

  • Ensure every single unit is tested
  • Provide statistically justified inspection to detect defects
  • Replace need for validation studies
  • Are only required for labels

Correct Answer: Provide statistically justified inspection to detect defects

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