Testing of packaging materials MCQs With Answer

Introduction

Testing of packaging materials is a critical component of Quality Control & Quality Assurance in pharmaceutical manufacturing. This blog provides M.Pharm students with focused multiple-choice questions that cover key analytical and physical tests used to evaluate primary and secondary packaging—such as barrier properties, seal integrity, mechanical strength, permeability (water vapour and oxygen), migration and extractables, and container-closure integrity. Questions emphasize standards, test methods, interpretation of results, and implications for product stability and patient safety. These MCQs are designed to reinforce theoretical knowledge and practical understanding needed for lab assessments, regulatory submissions, and packaging selection in drug development and quality assurance.

Q1. Which test is primarily used to quantify the amount of moisture passing through a packaging film over time?

• Oxygen Transmission Rate (OTR)
• Water Vapour Transmission Rate (WVTR)
• Helium Leak Test
• Tensile Strength Test

Correct Answer: Water Vapour Transmission Rate (WVTR)

Q2. Which parameter assesses the resistance of a sealed package to opening under tensile load?

• Puncture Resistance
• Peel Strength
• Burst Strength
• Compression Test

Correct Answer: Peel Strength

Q3. What is the most appropriate method to detect very small leaks in parenteral vial closures?

• Dye Ingress Test
• Vacuum Decay or Helium Leak Test (Container Closure Integrity)
• Seal Strength Measurement
• Burst Testing

Correct Answer: Vacuum Decay or Helium Leak Test (Container Closure Integrity)

Q4. Which test gives information about oxygen permeability of a packaging film?

• Water Vapour Transmission Rate
• Oxygen Transmission Rate (OTR)
• Thermogravimetric Analysis (TGA)
• Fourier Transform Infrared Spectroscopy (FTIR)

Correct Answer: Oxygen Transmission Rate (OTR)

Q5. Which analytical approach is used to identify potential drug-product leachables from polymeric packaging?

• Microbial Limit Test
• ICP-MS for elemental impurities only
• Extractables and Leachables study using GC-MS/LC-MS
• Water Activity Measurement

Correct Answer: Extractables and Leachables study using GC-MS/LC-MS

Q6. Which USP chapter or type of test is directly relevant for checking integrity of sterile parenteral packages?

• USP Physical Tests for weight variation
• USP Container-Closure System Integrity tests (e.g., USP <1226>)
• USP tests for dissolution
• USP microbial identification

Correct Answer: USP Container-Closure System Integrity tests (e.g., USP <1226>)

Q7. A packaging film shows a significant decrease in tensile strength after accelerated ageing. What does this most likely indicate?

• Improved barrier performance
• Polymer degradation reducing mechanical integrity
• Increased oxygen transmission resistance
• Reduced extractables

Correct Answer: Polymer degradation reducing mechanical integrity

Q8. Which test measures the force required to burst or rupture a flexible container under internal pressure?

• Burst Strength Test
• Peel Test
• Tensile Elongation at Break
• Water Vapour Transmission Rate

Correct Answer: Burst Strength Test

Q9. For photolabile drugs, which packaging characteristic is most critical to test?

• Thermal conductivity
• Light transmission or UV/VIS blocking capacity
• pH of the package surface
• Seal strength

Correct Answer: Light transmission or UV/VIS blocking capacity

Q10. Which method is commonly used to evaluate particulate contamination originating from packaging during stability?

• Gravimetric moisture analysis
• Particle counting and visual inspection (subvisible and visible particulate tests)
• Helium leak detection
• Oxygen permeation testing

Correct Answer: Particle counting and visual inspection (subvisible and visible particulate tests)

Q11. When validating a heat-sealable foil pouch, which of the following is essential to assess?

• Seal strength, seal appearance, and hot tack
• Only oxygen transmission rate
• Only film thickness across the pouch
• Only microbial limit testing

Correct Answer: Seal strength, seal appearance, and hot tack

Q12. Which thermal analysis technique helps determine melting point and crystallinity changes in polymer packaging?

• DSC (Differential Scanning Calorimetry)
• FTIR spectroscopy
• HPLC
• Gravimetric water content

Correct Answer: DSC (Differential Scanning Calorimetry)

Q13. What does a high oxygen transmission rate (OTR) imply for an oxygen-sensitive drug product?

• Better protection from oxygen
• Higher oxygen permeation, increasing risk of oxidation
• No effect because oxygen is inert
• Improved sterility assurance

Correct Answer: Higher oxygen permeation, increasing risk of oxidation

Q14. Which test assesses the ability of a container-closure to prevent microbial ingress during storage?

• Dye ingress test and microbial challenge for container-closure integrity
• Water Vapour Transmission Rate
• OTR measurement
• DSC analysis

Correct Answer: Dye ingress test and microbial challenge for container-closure integrity

Q15. In migration testing, why are multiple simulants used (e.g., aqueous, acidic, fatty)?

• To increase test complexity without benefit
• Different simulants mimic different product types and interactions with packaging
• Only to satisfy regulatory paperwork
• Because analytical methods require varied solvents

Correct Answer: Different simulants mimic different product types and interactions with packaging

Q16. Which property is particularly important for blister packaging used for hygroscopic tablets?

• High WVTR (Water Vapour Transmission Rate)
• Low WVTR (strong moisture barrier)
• High oxygen permeability
• Low tensile modulus only

Correct Answer: Low WVTR (strong moisture barrier)

Q17. Which regulatory guidance or standard is commonly referenced for packaging extractables and leachables risk assessment?

• ICH Q1A(R2) only
• USP <1663>/<1664> and ICH M7 and related FDA/EMA guidances
• ISO 9001 alone
• ICH Q3A impurity limits only

Correct Answer: USP <1663>/<1664> and ICH M7 and related FDA/EMA guidances

Q18. Which mechanical test simulates force applied by stacking boxes during storage and transit?

• Compression or crush test
• Peel strength
• OTR measurement
• DSC thermal scan

Correct Answer: Compression or crush test

Q19. Which analytical technique is suitable for detecting inorganic elemental contaminants leached from glass or metal closures?

• GC-MS
• ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
• HPLC-UV
• Microbial culture

Correct Answer: ICP-MS (Inductively Coupled Plasma Mass Spectrometry)

Q20. During accelerated ageing of packaged drug product, which packaging failure would most directly indicate loss of barrier function?

• Change in package color only
• Increase in moisture content of the drug and correlated degradation
• Minor cosmetic surface scratches
• Decrease in package weight due to volatile loss without product change

Correct Answer: Increase in moisture content of the drug and correlated degradation

Download