Selection of packaging materials for drug products is a critical subject for B.Pharm students, covering material types, barrier properties, compatibility, and regulatory requirements. Understanding primary and secondary packaging, glass (Type I–III), plastics (PET, PVC, HDPE, LDPE), metals, and laminates helps ensure drug stability, safety, and patient compliance. Key considerations include moisture, oxygen and light protection, extractables and leachables, container-closure integrity, sterilization compatibility, and cold-chain needs. Students must learn testing methods like MVTR, OTR, CCI and stability studies, plus sustainability and labeling regulations. Mastery of these topics supports rational packaging selection and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary function of primary packaging for an oral solid dosage form?
- To provide an outer shipping layer and branding
- To contain and directly protect the drug product from environmental factors
- To facilitate marketing and patient instructions
- To act as a secondary barrier during transportation
Correct Answer: To contain and directly protect the drug product from environmental factors
Q2. Which glass type is most suitable for parenteral products due to highest chemical durability?
- Type II
- Type III
- Type I (Borosilicate)
- Soda-lime glass
Correct Answer: Type I (Borosilicate)
Q3. Which property best describes the ability of a packaging material to prevent passage of water vapor?
- Oxygen transmission rate (OTR)
- Moisture vapor transmission rate (MVTR)
- Opacity
- Tensile strength
Correct Answer: Moisture vapor transmission rate (MVTR)
Q4. Which polymer is commonly used for shatter-resistant amber bottles and has good chemical resistance?
- Polyvinyl chloride (PVC)
- Polyethylene terephthalate (PET)
- High-density polyethylene (HDPE)
- Polystyrene (PS)
Correct Answer: High-density polyethylene (HDPE)
Q5. What is the main concern that extractables and leachables (E&L) studies address?
- Mechanical strength of packaging
- Potential toxicants migrating from packaging into the drug
- Cost of packaging materials
- Shelf layout and presentation
Correct Answer: Potential toxicants migrating from packaging into the drug
Q6. Which sealing property is essential for blister packs to maintain dosage unit protection?
- Heat conductivity
- Heat seal strength and integrity
- Flexural modulus
- Optical clarity
Correct Answer: Heat seal strength and integrity
Q7. For a sterile injectable, which container-closure concern is most critical?
- Label design
- Container-closure integrity to prevent microbial ingress
- Color matching
- Stacking strength for shipping
Correct Answer: Container-closure integrity to prevent microbial ingress
Q8. Which test measures the rate at which oxygen permeates through a packaging film?
- Water activity testing
- Oxygen transmission rate (OTR) test
- Headspace analysis
- Tensile testing
Correct Answer: Oxygen transmission rate (OTR) test
Q9. Which packaging material is most susceptible to photodegradation if a drug is light-sensitive?
- Amber glass
- Metal canisters
- Clear plastics without UV stabilizers
- Aluminum foil laminates
Correct Answer: Clear plastics without UV stabilizers
Q10. Which closure feature is important to prevent accidental ingestion by children?
- Tamper-evident band
- Child-resistant closure
- Flip-top cap
- Desiccant in cap
Correct Answer: Child-resistant closure
Q11. Which packaging approach is preferred for hygroscopic powders requiring low moisture exposure?
- Use of porous paper pouches
- Single-layer polyethylene films
- Multi-layer laminates with high moisture barrier plus desiccant
- Open trays with shrink-wrap
Correct Answer: Multi-layer laminates with high moisture barrier plus desiccant
Q12. Which sterilization method can cause polymer embrittlement and changes in mechanical properties?
- Ethylene oxide (EtO) at low temperatures
- Gamma irradiation at high doses
- Sterile filtration of final product
- Dry heat at moderate temperatures
Correct Answer: Gamma irradiation at high doses
Q13. Which parameter assesses the presence and amount of volatile degradation products in container headspace?
- Headspace gas analysis
- MVTR
- OTR
- Compression testing
Correct Answer: Headspace gas analysis
Q14. When selecting primary packaging for lyophilized sterile vials, which attribute is essential?
- High oxygen permeability
- Appropriate glass type and closure compatibility to maintain sterility and chemical stability
- Transparent plastic to view cake easily
- Large headspace volume to allow shaking
Correct Answer: Appropriate glass type and closure compatibility to maintain sterility and chemical stability
Q15. Co-extrusion of polymers in a film is mainly used to:
- Reduce production speed
- Create multi-layer films combining barrier and mechanical properties
- Increase film transparency only
- Make the film biodegradable
Correct Answer: Create multi-layer films combining barrier and mechanical properties
Q16. Which regulatory guidance is most relevant for container-closure systems and extractables/leachables?
- ICH Q10 only
- USP chapters and ICH guidance on stability and packaging, plus EMA/FDA E&L guidances
- ISO 9001 for quality management alone
- Good Distribution Practice only
Correct Answer: USP chapters and ICH guidance on stability and packaging, plus EMA/FDA E&L guidances
Q17. What issue can adsorption of drug molecules onto plastic surfaces cause?
- Improved dissolution rate
- Loss of assay potency and dose variability
- Enhanced flavor masking
- Reduced container weight
Correct Answer: Loss of assay potency and dose variability
Q18. Which material is favored for blister lidding foil due to excellent barrier properties?
- Paperboard
- Aluminum foil laminate
- Single-layer PVC film
- Cardboard lamination
Correct Answer: Aluminum foil laminate
Q19. For biologics sensitive to oxygen, which packaging strategy is appropriate?
- Use of oxygen barrier packaging and oxygen scavengers or inert gas headspace
- Transparent plastic bottles to monitor product
- Open trays for rapid cooling
- No sealing to allow gas exchange
Correct Answer: Use of oxygen barrier packaging and oxygen scavengers or inert gas headspace
Q20. Which mechanical property is critical for bottles to withstand transport and stacking?
- Permeability
- Tensile strength and compression resistance
- Optical clarity
- Surface energy
Correct Answer: Tensile strength and compression resistance
Q21. Which test directly evaluates container-closure integrity (CCI)?
- Visual inspection alone
- Dye ingress, vacuum decay, or helium leak testing
- pH measurement of contents
- UV-vis spectroscopy of the drug solution
Correct Answer: Dye ingress, vacuum decay, or helium leak testing
Q22. Which factor is least relevant when selecting secondary packaging for bulk shipments?
- Protection against mechanical shocks and moisture
- Regulatory storage temperature requirements
- Branding color schemes
- Compatibility with palletization and transport modes
Correct Answer: Branding color schemes
Q23. Which packaging option is most suitable for unit-dose ophthalmic drops sterile single-use vials?
- Re-sealable multidose bottle
- Single-use sterile ampoules or unit-dose polyethylene vials
- Paper sachets
- Blister packs designed for tablets
Correct Answer: Single-use sterile ampoules or unit-dose polyethylene vials
Q24. What does MVTR value help predict about a packaged product?
- Optical clarity under stress
- Rate of moisture ingress through the package film
- Resistance to thermal degradation
- Leaching of plasticizers
Correct Answer: Rate of moisture ingress through the package film
Q25. Which practice reduces risk of leachables in a finished drug product?
- Choosing materials without prior E&L data
- Conducting extractables and leachables studies and selecting compatible materials
- Using highest porosity materials
- Avoiding secondary packaging
Correct Answer: Conducting extractables and leachables studies and selecting compatible materials
Q26. For cold-chain biologics, which packaging attribute is essential?
- High oxygen permeability
- Thermal insulation and validated temperature control during transport
- Permeable labels for breathability
- Transparent outer cartons
Correct Answer: Thermal insulation and validated temperature control during transport
Q27. Which closure system helps provide tamper-evidence for sealed bottles?
- Screw cap without band
- Tamper-evident band or break-away seal
- Loose cork stopper
- Snap-fit cap with no seal
Correct Answer: Tamper-evident band or break-away seal
Q28. Which analytical approach is used to identify volatile and semi-volatile extractables?
- High-performance liquid chromatography (HPLC) only
- Gas chromatography–mass spectrometry (GC-MS)
- X-ray diffraction
- Mechanical tensile testing
Correct Answer: Gas chromatography–mass spectrometry (GC-MS)
Q29. Which sustainable packaging practice is appropriate without compromising drug stability?
- Switching to low-barrier single-layer films for all products
- Evaluating recyclable or reduced-weight materials that meet barrier and compatibility requirements
- Eliminating primary packaging altogether
- Using biodegradable films without testing
Correct Answer: Evaluating recyclable or reduced-weight materials that meet barrier and compatibility requirements
Q30. When a drug adsorbs to a plastic syringe, what mitigation step is useful?
- Increase storage temperature
- Choose an alternative material or apply inert coating to reduce adsorption
- Use a larger syringe volume only
- Replace the drug with a different active ingredient
Correct Answer: Choose an alternative material or apply inert coating to reduce adsorption
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.
Mail- Sachin@pharmacyfreak.com