Containers for ophthalmic products MCQs With Answer

Containers for ophthalmic products MCQs With Answer provide B.Pharm students a focused review of packaging, closure systems, materials, sterility, dropper design, preservatives, and regulatory considerations for eye formulations. This resource covers single-dose and multi-dose containers, glass and polymer choices (borosilicate, LDPE, HDPE), leachables, adsorption, drop size control, terminal sterilization versus aseptic filling, particulate control, and compatibility with ophthalmic formulations. Emphasis is on practical aspects—container closure integrity, preservative efficacy, metered systems, and stability—so students can apply pharmaceutical quality and regulatory principles. Concise explanations and answers reinforce learning and exam preparation. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which material is preferred for sterile ophthalmic vials due to high chemical resistance and low extractables?

• Type I borosilicate glass
• Polyethylene terephthalate (PET)
• Low density polyethylene (LDPE)
• Polypropylene (PP)

Correct Answer: Type I borosilicate glass

Q2. Single‑dose ophthalmic containers are mainly used to avoid which issue in preservative-free formulations?

• Light sensitivity
• Microbial contamination on repeated use
• Osmolality changes
• Excessive drop size

Correct Answer: Microbial contamination on repeated use

Q3. Which closure feature controls drop size and flow in many ophthalmic multi‑dose bottles?

• Child‑resistant cap
• Metered pump
• Dropper orifice geometry
• Tamper‑evident band

Correct Answer: Dropper orifice geometry

Q4. Which sterilization method is commonly unsuitable for most ophthalmic plastic containers due to material deformation?

• Ethylene oxide sterilization
• Dry heat sterilization
• Gamma irradiation
• Steam (autoclave) sterilization

Correct Answer: Steam (autoclave) sterilization

Q5. What is the primary purpose of preservatives in multi‑dose ophthalmic formulations?

• Improve viscosity
• Prevent oxidation
• Maintain sterility during repeated use
• Reduce osmolarity

Correct Answer: Maintain sterility during repeated use

Q6. Which container attribute is most critical to prevent ingress of contaminants after dispensing?

• Color of the bottle
• Container closure integrity (CCI)
• Label font size
• Presence of a tamper band

Correct Answer: Container closure integrity (CCI)

Q7. Which polymer is commonly used for squeezable ophthalmic dropper bottles due to flexibility and compatibility?

• Polystyrene (PS)
• Low density polyethylene (LDPE)
• Polyvinyl chloride (PVC)
• Polycarbonate (PC)

Correct Answer: Low density polyethylene (LDPE)

Q8. Metered dose eye dropper systems are primarily designed to:

• Preserve medication without preservatives
• Deliver a fixed, reproducible drop volume
• Increase shelf life dramatically
• Allow multiple drugs in one container

Correct Answer: Deliver a fixed, reproducible drop volume

Q9. Which test is commonly used to assess container closure integrity for ophthalmic containers?

• Dissolution testing
• Dye ingress or vacuum decay
• pH testing
• Viscosity measurement

Correct Answer: Dye ingress or vacuum decay

Q10. Which type of glass is specified as Type I?

• Soda‑lime glass
• Borosilicate glass
• Aluminosilicate glass
• Lead glass

Correct Answer: Borosilicate glass

Q11. Which problem can arise from adsorption of drug to plastic container surfaces?

• Increased microbial load
• Reduced available drug concentration
• Enhanced preservative action
• Improved viscosity

Correct Answer: Reduced available drug concentration

Q12. For light‑sensitive ophthalmic solutions, which container characteristic is important?

• Opaque or UV‑protective packaging
• Transparent PET for visuals
• Wide mouth for aeration
• Porous closure

Correct Answer: Opaque or UV‑protective packaging

Q13. Which regulatory document specifically addresses sterility assurance and packaging for ophthalmic products?

• ICH Q5C
• USP chapters relevant to ophthalmic preparations (e.g., USP Sterility)
• ICH Q9 only
• WHO GMP Annex on Capsules

Correct Answer: USP chapters relevant to ophthalmic preparations (e.g., USP Sterility)

Q14. Which closure design helps prevent backflow and contamination in multi‑dose ophthalmic containers?

• Vent hole in cap
• One‑way valve or anti‑reflux system
• Loose screw cap
• Flip‑top cap without valve

Correct Answer: One‑way valve or anti‑reflux system

Q15. Which analytical concern is critical when using gamma irradiation on ophthalmic plastic containers?

• Change in bottle color only
• Generation of radiolytic degradation products (leachables)
• Decrease in drop size
• Increase in osmolarity

Correct Answer: Generation of radiolytic degradation products (leachables)

Q16. What is an advantage of single‑unit dose ampoules for ophthalmics?

• Lower manufacturing cost than multi‑dose
• No need for preservatives and reduced contamination risk
• They are reusable
• They always allow metered dosing

Correct Answer: No need for preservatives and reduced contamination risk

Q17. Which property of the formulation most directly affects drop size from a fixed orifice?

• pH only
• Viscosity and surface tension
• Color
• Microbial content

Correct Answer: Viscosity and surface tension

Q18. Which closure material is often used for rubber stoppers in sterile ophthalmic vials?

• Natural latex without treatment
• Bromobutyl or chlorobutyl rubber
• Unplasticized PVC
• Silicone oil alone

Correct Answer: Bromobutyl or chlorobutyl rubber

Q19. Which container characteristic helps limit particle generation during dispensing?

• Sharp edged orifice
• Smooth internal surfaces and proper filtration during manufacturing
• Use of colored inks on label
• Larger bottle volume

Correct Answer: Smooth internal surfaces and proper filtration during manufacturing

Q20. In stability studies, why is the headspace in ophthalmic containers monitored?

• To measure drop size
• To assess oxygen or moisture ingress and potential product degradation
• To check label adhesion
• To ensure color uniformity

Correct Answer: To assess oxygen or moisture ingress and potential product degradation

Q21. Which feature distinguishes a metered multi‑dose ophthalmic dispenser from a regular dropper?

• Presence of preservative
• Mechanism that dispenses an exact microvolume per actuation
• Opaque bottle material
• Removable tip

Correct Answer: Mechanism that dispenses an exact microvolume per actuation

Q22. What is the major risk when packaging ionic ophthalmic drugs in certain plastics?

• Increased viscosity
• Adsorption or binding to the plastic surface reducing potency
• Automatic pH buffering
• Spontaneous sterilization

Correct Answer: Adsorption or binding to the plastic surface reducing potency

Q23. Which testing parameter ensures that an ophthalmic container releases the correct volume per drop?

• Particle size analysis
• Drop weight or drop volume test
• pH stability test
• Color stability

Correct Answer: Drop weight or drop volume test

Q24. Which of the following is a common preservative used in ophthalmic multi‑dose solutions?

• Benzalkonium chloride (BAK)
• Sodium chloride
• Polysorbate 80
• Sucrose

Correct Answer: Benzalkonium chloride (BAK)

Q25. Which risk is reduced by using tamper‑evident seals on ophthalmic containers?

• Drug photodegradation
• Deliberate or accidental product contamination after manufacturing
• Adsorption to container walls
• Decreased viscosity

Correct Answer: Deliberate or accidental product contamination after manufacturing

Q26. Which factor is most important when selecting a container for a viscous ophthalmic gel?

• Color of the cap
• Compatibility of piston/closure with high viscosity and ability to dispense
• Ability to autoclave at 200°C
• Magnetic properties

Correct Answer: Compatibility of piston/closure with high viscosity and ability to dispense

Q27. Why are ISO and USP particulate limits relevant for ophthalmic packaging?

• They regulate label text only
• Particles in ophthalmic products can cause irritation or blindness, so limits protect safety
• They control bottle color
• They determine viscosity standards

Correct Answer: Particles in ophthalmic products can cause irritation or blindness, so limits protect safety

Q28. Which approach reduces leachable migration from plastic containers into ophthalmic solutions?

• Increasing storage temperature
• Choosing low‑extractable polymers and performing extractables/leachables studies
• Using darker label inks
• Adding more preservative

Correct Answer: Choosing low‑extractable polymers and performing extractables/leachables studies

Q29. For sterile ophthalmic products, what is the main advantage of terminal sterilization over aseptic filling?

• Lower temperature processing
• Often higher sterility assurance because product and container are sterilized together
• Elimination of need for filtration
• Better color retention

Correct Answer: Often higher sterility assurance because product and container are sterilized together

Q30. Which closure addition helps visually impaired patients identify left/right bottles or dosing schedules?

• Use of child‑resistant caps only
• Tactile markers or raised symbols on caps
• Larger labels with tiny font
• Unlabeled clear caps

Correct Answer: Tactile markers or raised symbols on caps

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