Quality control of packaging materials MCQs With Answer

Introduction: Quality control of packaging materials is essential in pharmaceutical manufacturing to ensure drug stability, safety, and efficacy throughout shelf life. For M.Pharm students, understanding test methods, regulatory requirements, and interpretation of results is critical for designing robust container-closure systems. This blog presents focused MCQs that cover physical, chemical, and microbiological evaluation of primary and secondary packaging — including barrier property tests (OTR, MVTR), seal integrity, extractables/leachables, mechanical strength, and relevant standards (USP, EP, ASTM). These questions aim to deepen conceptual knowledge and exam preparedness by emphasizing practical test selection, acceptance criteria, and failure modes encountered in packaging QC and validation.

Q1. Which test is most appropriate to quantify the rate at which water vapor passes through a polymeric packaging film?

• Oxygen Transmission Rate (OTR)
• Water Activity (aw)
• Moisture Vapor Transmission Rate (MVTR)
• Headspace Gas Analysis

Correct Answer: Moisture Vapor Transmission Rate (MVTR)

Q2. What is the primary purpose of a dye ingress (leak) test for blister packs?

• To measure oxygen permeability of the blister film
• To identify gross sealing defects and through-holes allowing liquid penetration
• To evaluate the mechanical tensile strength of the foil lidding
• To quantify extractable impurities from the adhesive

Correct Answer: To identify gross sealing defects and through-holes allowing liquid penetration

Q3. Which analytical approach is most suitable for detecting volatile organic extractables from packaging adhesives?

• High Performance Liquid Chromatography (HPLC)
• Headspace Gas Chromatography–Mass Spectrometry (GC-MS)
• Fourier Transform Infrared Spectroscopy (FTIR)
• Dynamic Vapor Sorption (DVS)

Correct Answer: Headspace Gas Chromatography–Mass Spectrometry (GC-MS)

Q4. In seal integrity testing of sterile parenteral containers, which non-destructive method is commonly used to detect micro-leaks?

• Dye ingress immersion
• Vacuum decay testing
• Destructive burst testing
• Moisture sorption analysis

Correct Answer: Vacuum decay testing

Q5. Which parameter describes the amount of oxygen that permeates through a packaging film under specified conditions?

• Water Vapor Transmission Rate (WVTR)
• Oxygen Transmission Rate (OTR)
• Permeate Flux Index (PFI)
• Diffusion Coefficient Index (DCI)

Correct Answer: Oxygen Transmission Rate (OTR)

Q6. Which test provides a direct assessment of a glass vial’s resistance to breakage under compressive load during handling?

• Tensile strength test
• Compression (crush) test
• Puncture resistance test
• Accelerated aging

Correct Answer: Compression (crush) test

Q7. For determining particulate contamination from a plastic syringe barrel, which QC method is most appropriate?

• Gravimetric moisture analysis
• Visual inspection under defined lighting and magnification
• Seal burst test
• Oxygen headspace analysis

Correct Answer: Visual inspection under defined lighting and magnification

Q8. What is the significance of performing accelerated aging studies on packaging materials?

• To measure real-time mechanical fatigue only
• To predict long-term stability and identify potential material failures under elevated stress conditions
• To determine immediate microbial contamination
• To evaluate only color fastness of printed labels

Correct Answer: To predict long-term stability and identify potential material failures under elevated stress conditions

Q9. Which standard is commonly referenced for testing seal strength of pharmaceutical heat-sealed pouches?

• USP only
• ASTM or ISO methods for seal strength (e.g., ASTM F88)
• EPA aerosol guidelines
• ICH Q10

Correct Answer: ASTM or ISO methods for seal strength (e.g., ASTM F88)

Q10. In evaluation of container-closure systems, which test would best reveal changes in headspace gas composition over shelf life?

• Gravimetric water uptake
• Headspace gas analysis (e.g., GC with thermal conductivity or MS detection)
• Seal peel adhesion test
• Light transmission (UV-Vis) test

Correct Answer: Headspace gas analysis (e.g., GC with thermal conductivity or MS detection)

Q11. Which packaging material attribute most directly affects oxygen ingress and drug oxidation risk?

• Surface gloss
• Barrier property (OTR) and material permeability
• Ink adhesion
• Thermal conductivity

Correct Answer: Barrier property (OTR) and material permeability

Q12. Which QC test is used to assess the susceptibility of flexible films to puncture by sharp objects?

• Burst strength test
• Puncture resistance test
• Adhesive tack test
• Opacity measurement

Correct Answer: Puncture resistance test

Q13. What is the main regulatory concern addressed by extractables and leachables (E&L) testing of packaging?

• Mechanical durability of packaging
• Chemical safety: potential migration of toxic or pharmacologically active substances into the drug
• Visual appearance consistency
• Barrier performance against microbes

Correct Answer: Chemical safety: potential migration of toxic or pharmacologically active substances into the drug

Q14. Which method is non-destructive and detects electrical conductivity changes due to leaks in thin flexible packaging?

• High voltage leak detection (HVLD)
• Dye ingress immersion test
• Vacuum leak test only
• Headspace GC analysis

Correct Answer: High voltage leak detection (HVLD)

Q15. For sterile lyophilized drug vials, which packaging QC parameter is crucial to ensure container-closure sterility over shelf life?

• Label print quality
• Closure integrity and crimp seal uniformity
• Color of the rubber stopper
• Vial optical clarity

Correct Answer: Closure integrity and crimp seal uniformity

Q16. Which test quantifies the adhesive force required to peel a lidding foil from blister plastic?

• Peel strength or peel adhesion test
• Burst strength test
• Oxygen permeability test
• Headspace analysis

Correct Answer: Peel strength or peel adhesion test

Q17. Which technique is most appropriate to identify polymer type and detect contamination or formulation changes in plastic packaging?

• Fourier Transform Infrared Spectroscopy (FTIR)
• Seal strength testing
• Moisture vapor transmission measurement
• Visual inspection only

Correct Answer: Fourier Transform Infrared Spectroscopy (FTIR)

Q18. When specifying acceptance criteria for packaging QC, which principle should guide setting limits?

• Make limits as tight as instrument detection allows regardless of product needs
• Set limits based on product risk, performance requirements, and validated test variability
• Use competitor specifications without evaluation
• Choose arbitrary round numbers for convenience

Correct Answer: Set limits based on product risk, performance requirements, and validated test variability

Q19. Which accelerated test condition is commonly used to simulate long-term photodegradation of packaging materials?

• High humidity alone
• Controlled light exposure using specified UV/visible irradiance (photostability testing)
• Freezing cycles only
• Vacuum exposure

Correct Answer: Controlled light exposure using specified UV/visible irradiance (photostability testing)

Q20. Which property of glass containers is most directly assessed by an alkali (Na2O) leach test or hydrolytic resistance test?

• Mechanical strength under impact
• Chemical durability and resistance to aqueous leaching (hydrolytic stability)
• Optical clarity
• Surface roughness

Correct Answer: Chemical durability and resistance to aqueous leaching (hydrolytic stability)

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