Quality control tests for packaging materials MCQs With Answer are essential for B.Pharm students to understand how packaging preserves drug safety, efficacy, and shelf life. This introduction covers key concepts such as barrier properties, seal integrity, moisture and oxygen transmission rates (WVTR/OTR), migration, extractables and leachables, physical strength tests, microbial protection, and regulatory standards (USP/IP/ISO). Practical methods include tensile, burst, dye penetration, helium leak, GC-MS/LC-MS for migration, and accelerated aging for stability assessment. Mastery of these topics ensures proper selection, validation, and documentation of pharmaceutical packaging systems. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of quality control tests for pharmaceutical packaging materials?
- Ensure integrity and protection of product
- Reduce manufacturing cost
- Increase aesthetic appeal of the package
- Accelerate market launch time
Correct Answer: Ensure integrity and protection of product
Q2. Which test measures the amount of water vapor passing through a packaging film per unit area and time?
- Oxygen Transmission Rate (OTR)
- Water Vapor Transmission Rate (WVTR)
- Permeability Index (PI)
- Helium Leak Rate (HLR)
Correct Answer: Water Vapor Transmission Rate (WVTR)
Q3. Which technique is most appropriate for detecting seal leaks in sterile unit-dose blister packs?
- Visual inspection only
- Dye penetration test
- Tensile strength test
- Fourier-transform infrared spectroscopy (FTIR)
Correct Answer: Dye penetration test
Q4. Which analytical method is commonly used to identify volatile organic extractables from packaging materials?
- Gas Chromatography-Mass Spectrometry (GC-MS)
- Thermogravimetric Analysis (TGA)
- Optical Microscopy
- Seal Strength Tester
Correct Answer: Gas Chromatography-Mass Spectrometry (GC-MS)
Q5. What does Container Closure Integrity Testing (CCIT) primarily assess?
- Color stability of the container
- Mechanical strength of the outer carton
- Absence of pathways for contamination or gas exchange
- Compliance with printing requirements
Correct Answer: Absence of pathways for contamination or gas exchange
Q6. Which test is used to determine the resistance of glass containers to hydrolytic attack?
- Hydrolytic resistance test
- Burst pressure test
- Seal strength test
- Optical clarity test
Correct Answer: Hydrolytic resistance test
Q7. Which parameter is most relevant for packaging materials used in oxygen-sensitive pharmaceutical formulations?
- Oxygen Transmission Rate (OTR)
- Seal appearance
- Elastic modulus
- Surface roughness
Correct Answer: Oxygen Transmission Rate (OTR)
Q8. Which test provides quantitative measurement of the force required to separate a sealed package?
- Tensile strength test
- Seal strength (peel) test
- Burst test
- Dye ingress test
Correct Answer: Seal strength (peel) test
Q9. Which accelerated condition is commonly used to simulate long-term stability of packaging over a short period?
- Freezer storage at -20°C
- High humidity and elevated temperature (e.g., 40°C/75% RH)
- Room temperature in the dark
- Submersion in water for 24 hours
Correct Answer: High humidity and elevated temperature (e.g., 40°C/75% RH)
Q10. What is the main concern addressed by extractables and leachables (E&L) testing for packaging?
- Mechanical durability of the package
- Toxicological risk from compounds migrating into the drug product
- Colorfastness of printed inks
- Barrier properties against light
Correct Answer: Toxicological risk from compounds migrating into the drug product
Q11. Which instrument is useful for characterizing surface morphology and particulate contamination on packaging films?
- UV-Vis spectrophotometer
- Scanning Electron Microscope (SEM)
- pH meter
- Seal strength tester
Correct Answer: Scanning Electron Microscope (SEM)
Q12. Which compendial standard often guides testing for pharmaceutical packaging materials?
- ISO 9000 only
- United States Pharmacopeia (USP) and Indian Pharmacopoeia (IP)
- FDA Cosmetic Guidelines
- IEC electrical safety standards
Correct Answer: United States Pharmacopeia (USP) and Indian Pharmacopoeia (IP)
Q13. What is the primary indicator measured in a burst test for flexible containers?
- Optical clarity under load
- Pressure at which the container ruptures
- Surface pH changes
- Thermal expansion coefficient
Correct Answer: Pressure at which the container ruptures
Q14. Which test helps detect microscopic leaks by measuring changes in vacuum or pressure over time?
- Visual inspection
- Vacuum decay test
- Dye ingress visual test
- Moisture sorption analysis
Correct Answer: Vacuum decay test
Q15. Which property is critical for blister packaging intended for light-sensitive drugs?
- High oxygen permeability
- Light/UV barrier or opacity
- Increased moisture uptake
- Reduced seal strength
Correct Answer: Light/UV barrier or opacity
Q16. Which test is used to evaluate the thermal shrink behavior of heat-sealable films?
- Shrinkage or heat-shrink testing
- Hydrolytic resistance test
- FTIR spectrum matching
- Oxygen permeability test
Correct Answer: Shrinkage or heat-shrink testing
Q17. For assessing chemical compatibility between drug formulation and container, which study is most relevant?
- Friability testing
- Drug–container interaction and migration studies
- Visual inspection of labeling
- Seal torque measurement
Correct Answer: Drug–container interaction and migration studies
Q18. Which test would detect particulate shedding from a syringe barrel or plunger?
- Particulate matter testing (subvisible particles)
- OTR measurement
- Seal strength test
- Hydrolytic resistance test
Correct Answer: Particulate matter testing (subvisible particles)
Q19. Which analytical approach is preferred for non-volatile extractables profiling?
- Gas Chromatography (GC) only
- Liquid Chromatography-Mass Spectrometry (LC-MS)
- Visual color comparison
- Seal strength analysis
Correct Answer: Liquid Chromatography-Mass Spectrometry (LC-MS)
Q20. Which test evaluates mechanical resistance of packaging film to tearing under tension?
- Tear resistance or Elmendorf tear test
- UV-Vis transmission test
- Helium leak detection
- Microbial challenge test
Correct Answer: Tear resistance or Elmendorf tear test
Q21. What does a microbial challenge test for packaging typically evaluate?
- Barrier to microbial ingress under defined conditions
- Seal color uniformity
- Film tensile modulus
- Oxygen scavenger capacity
Correct Answer: Barrier to microbial ingress under defined conditions
Q22. Which test is commonly applied to parenteral primary containers to ensure they do not leach alkali?
- Alkali resistance test
- WVTR measurement
- Seal strength test
- Optical density test
Correct Answer: Alkali resistance test
Q23. In packaging QC, what is the significance of a headspace analysis in filled vials?
- To evaluate particulate matter in solution
- To measure residual oxygen or volatile impurities in the headspace
- To determine seal peel strength
- To test glass delamination visually
Correct Answer: To measure residual oxygen or volatile impurities in the headspace
Q24. Which failure mode is detected by helium leak testing for packaging systems?
- Gross cosmetic defects only
- Sub-microscopic leaks in seals or closures
- Moisture uptake rate
- UV migration
Correct Answer: Sub-microscopic leaks in seals or closures
Q25. Which test is most useful to quantify the optical clarity and light transmission of transparent packaging?
- FTIR spectroscopy
- UV-Visible spectrophotometry
- Seal integrity manual check
- Thermal shrink test
Correct Answer: UV-Visible spectrophotometry
Q26. What does delamination testing of glass vials check for?
- Coating adhesion and glass flaking from the inner surface
- Oxygen permeability
- Seal tensile strength
- Label adhesion
Correct Answer: Coating adhesion and glass flaking from the inner surface
Q27. Which parameter is critical for cold chain packaging used for vaccines?
- High WVTR to allow moisture ingress
- Thermal insulation and temperature stability
- Low seal strength for easy opening
- Transparent films for sunlight exposure
Correct Answer: Thermal insulation and temperature stability
Q28. Which test assesses the release of particulate contaminants during simulated handling of a container?
- Handling simulation and particulate shedding test
- OTR measurement
- Helium leak testing
- Alkali resistance test
Correct Answer: Handling simulation and particulate shedding test
Q29. In packaging validation, which documentation demonstrates that test methods are suitable and reproducible?
- Instrument brochures
- Method validation reports and standard operating procedures (SOPs)
- Artwork proofs
- Purchase orders for materials
Correct Answer: Method validation reports and standard operating procedures (SOPs)
Q30. Which regulatory consideration must be addressed when selecting packaging materials for pharmaceuticals?
- Color matching with brand logo only
- Compliance with compendial limits, safety (E&L), and stability requirements
- Lowest possible cost regardless of compatibility
- Use of the most opaque materials available
Correct Answer: Compliance with compendial limits, safety (E&L), and stability requirements
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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