QC tests for containers, closures and packaging materials MCQs With Answer

Introduction: This quiz collection on QC tests for containers, closures, and packaging materials is designed for M.Pharm students preparing for higher-level coursework and exams in Quality Control & Quality Assurance. It focuses on key analytical, physical and microbiological tests used to qualify pharmaceutical packaging systems — including glass, plastics, elastomers and seals — and the reason these tests matter for drug stability, sterility and patient safety. The questions highlight regulatory expectations, common instrumental techniques, functional performance tests (seal strength, CCI, MVTR/OTR), and extractables/leachables considerations. Use these MCQs to deepen conceptual understanding and practical application of packaging QC in pharmaceutical development and manufacturing.

Q1. Which USP chapter specifically addresses requirements for plastics used in pharmaceutical packaging?

• USP <787> – Particulate Matter in Injections
• USP <381> – Elastomeric Closures for Injections
• USP <661> – Plastic Packaging Systems and their Materials of Construction
• USP <1225> – Validation of Compendial Methods

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

Q2. Which of the following glass types is classified as Type I and is preferred for most injectable products due to superior hydrolytic resistance?

• Soda-lime glass (Type III)
• Borosilicate glass (Type I)
• Flint glass (Type II)
• Aluminosilicate glass (unclassified)

Correct Answer: Borosilicate glass (Type I)

Q3. Which container-closure integrity (CCI) method is considered the most sensitive deterministic leak test for detecting very small leaks?

• Dye ingress (methylene blue) immersion test
• Vacuum bubble emission (bubble test)
• Helium mass spectrometer leak detection
• High-voltage leak detection (HVLD)

Correct Answer: Helium mass spectrometer leak detection

Q4. Which test quantifies the rate at which water vapor passes through a packaging film and is critical for moisture-sensitive drugs?

• Oxygen Transmission Rate (OTR)
• Moisture Vapor Transmission Rate (MVTR) – gravimetric method
• Water Activity (aw) measurement
• Contact angle measurement

Correct Answer: Moisture Vapor Transmission Rate (MVTR) – gravimetric method

Q5. For determining oxygen permeability of packaging films, which measurement technique is commonly used?

• Fourier transform infrared spectroscopy (FTIR)
• Oxygen Transmission Rate (OTR) measured by coulometric sensor
• Thermogravimetric analysis (TGA)
• Ultraviolet-visible spectroscopy (UV-Vis)

Correct Answer: Oxygen Transmission Rate (OTR) measured by coulometric sensor

Q6. Which QC test is most appropriate to evaluate the bond strength of the heat-seal between a blister lidding foil and the blister base?

• Peel strength (seal strength) test
• Hot tack for film before sealing
• Burst test for package integrity
• Visual inspection only

Correct Answer: Peel strength (seal strength) test

Q7. To characterize non-volatile organic extractables from a polymeric closure, which analytical technique is typically preferred?

• Gas chromatography-mass spectrometry (GC-MS) only
• Inductively coupled plasma mass spectrometry (ICP-MS)
• Liquid chromatography coupled with mass spectrometry (LC-MS)
• Atomic absorption spectroscopy (AAS)

Correct Answer: Liquid chromatography coupled with mass spectrometry (LC-MS)

Q8. Which USP chapter provides compendial tests and specifications for elastomeric closures used for injections?

• USP <785> – Bacterial Endotoxins Test
• USP <381> – Elastomeric Closures for Injections
• USP <51> – Antimicrobial Effectiveness Testing
• USP <661> – Plastic Packaging Systems

Correct Answer: USP <381> – Elastomeric Closures for Injections

Q9. Which mechanical test assesses the resistance of a flexible pouch or film to rupture under increasing internal pressure?

• Tensile strength at break
• Puncture resistance (burst strength) test
• Peel strength test
• Compression set

Correct Answer: Puncture resistance (burst strength) test

Q10. Which particle testing method is commonly used to quantify sub-visible particles in parenteral containers?

• Gravimetric particulate capture
• Light obscuration particle count (per USP <788>)
• Microscopy only
• Visual inspection under white light

Correct Answer: Light obscuration particle count (per USP <788>)

Q11. Glass delamination (flake formation) is best detected by which approach?

• Colorimetric pH strips
• Filtration of the solution followed by elemental analysis (ICP-MS/OES) to detect silica/aluminum particulates
• Only visual inspection of the container exterior
• Thermal analysis (DSC)

Correct Answer: Filtration of the solution followed by elemental analysis (ICP-MS/OES) to detect silica/aluminum particulates

Q12. Which test provides a biological challenge to assess sterility maintenance of a packaging system under simulated stress?

• Microbial ingress/bacterial challenge test
• Oxygen ingress test
• Thermal cycling only
• Color stability test under light exposure

Correct Answer: Microbial ingress/bacterial challenge test

Q13. Which regulatory-relevant migration test assesses the total amount of non-volatile material that can migrate from packaging into a food simulant or drug product medium?

• Specific migration of a single compound
• Overall migration test
• Loss on drying
• Residue on ignition

Correct Answer: Overall migration test

Q14. Which spectral technique is most useful for identifying polymer type and functional groups of closures and films during QC?

• Ultraviolet-visible spectroscopy (UV-Vis)
• Fourier transform infrared spectroscopy (FTIR)
• Flame photometry
• Gel permeation chromatography (GPC)

Correct Answer: Fourier transform infrared spectroscopy (FTIR)

Q15. What does the “hot tack” test evaluate for a heat-sealable film used in pharmaceutical packaging?

• The ultimate tensile strength at room temperature
• The initial strength of a freshly formed heat-seal while still hot
• The oxygen permeability of the finished package
• The chemical resistance to solvents

Correct Answer: The initial strength of a freshly formed heat-seal while still hot

Q16. Which QC measurement is used to ensure a screw cap will remain tight and is measurable by a torque tester?

• Seal peel strength
• Cap torque (closure torque)
• Puncture resistance
• Optical clarity

Correct Answer: Cap torque (closure torque)

Q17. Which non-destructive packaging integrity test, often used for pouches and sealed trays, detects leaks by observing pressure change in a chamber?

• Bubble emission immersion test
• Vacuum decay test (chamber-based pressure decay)
• Dye ingress destructive test
• Visual seal inspection only

Correct Answer: Vacuum decay test (chamber-based pressure decay)

Q18. Which test is used to quantify volatile matter or moisture loss from polymeric packaging prior to stability studies?

• Loss on drying (moisture/volatile content)
• ICP-MS for metal contaminants
• Hot tack measurement
• Optical density (OD) measurement

Correct Answer: Loss on drying (moisture/volatile content)

Q19. To quantify elemental impurities leached from glass or metal closures into a drug product, which analytical method is commonly used?

• Gas chromatography with flame ionization detector (GC-FID)
• Inductively coupled plasma mass spectrometry (ICP-MS)
• FTIR spectroscopy
• Nuclear magnetic resonance (NMR)

Correct Answer: Inductively coupled plasma mass spectrometry (ICP-MS)

Q20. Which approach is appropriate to evaluate packaging material compatibility with terminal sterilization by gamma irradiation?

• Only visual inspection pre-irradiation
• Post-irradiation physical and chemical stability testing (tensile, seal strength, extractables profiling)
• Moisture Vapor Transmission Rate measured once only before irradiation
• Bioburden testing only

Correct Answer: Post-irradiation physical and chemical stability testing (tensile, seal strength, extractables profiling)

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