Manufacturing defects of capsules MCQs With Answer

Manufacturing defects of capsules MCQs With Answer

Understanding manufacturing defects of capsules is essential for B.Pharm students preparing for quality control, formulation development, and regulatory inspection. This concise guide focuses on common defects—such as leakage, brittleness, weight variation, sticking, mottling, and improper sealing—causes like moisture imbalance, poor powder flow, segregation and processing errors, detection methods (visual inspection, disintegration, dissolution, vacuum/dye leak tests, Karl Fischer moisture determination) and preventive measures. Keywords: capsule defects, hard gelatin capsules, softgel, weight variation, moisture content, plasticizers, filling machine, quality control, leakage test, disintegration. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the most common cause of brittleness in hard gelatin capsules?

• Low moisture content in the gelatin shell
• Excess plasticizer in the shell
• High fill weight of powder
• Insufficient capsule locking

Correct Answer: Low moisture content in the gelatin shell

Q2. Which defect occurs when capsule shells adhere to each other during processing?

• Capping
• Sticking
• Swelling
• Twinning

Correct Answer: Sticking

Q3. Weight variation of filled hard gelatin capsules is most frequently caused by which factor?

• Poor powder flow and inconsistent filling
• Excessive shell colorant
• Ambient light exposure
• High microbial load

Correct Answer: Poor powder flow and inconsistent filling

Q4. Which test is commonly used to detect leakage in soft gelatin capsules?

• Disintegration test
• Vacuum (leak) test
• Friability test
• Uniformity of content test

Correct Answer: Vacuum (leak) test

Q5. Excessive moisture in hard gelatin capsule shells typically causes:

• Brittleness and cracking
• Softening and increased microbial risk
• Permanent shrinkage
• Decreased solubility of the fill

Correct Answer: Softening and increased microbial risk

Q6. Which plasticizers are commonly used in soft gelatin capsule shells?

• Sorbitol and glycerol
• Propylene glycol and ethanol
• Magnesium stearate and talc
• Polyethylene glycol 4000 and stearic acid

Correct Answer: Sorbitol and glycerol

Q7. Mottling or uneven color on capsule shells is usually due to:

• Improper capsule filling weight
• Uneven distribution of colorant or moisture migration
• Excessive sealing temperature
• Use of HPMC shells instead of gelatin

Correct Answer: Uneven distribution of colorant or moisture migration

Q8. The disintegration test for capsules measures:

• The time taken for the fill to dissolve completely
• The time for the capsule shell to break down into particles
• The tensile strength of the capsule shell
• The weight variation between capsules

Correct Answer: The time for the capsule shell to break down into particles

Q9. What is the term for two capsules that become joined together during handling?

• Sticking
• Twinning (or agglomeration)
• Capping
• Lamination

Correct Answer: Twinning (or agglomeration)

Q10. The best storage condition to minimize capsule shell defects is:

• High temperature and high humidity
• Cool, dry place away from humidity
• Direct sunlight at room temperature
• Frozen storage at -20°C

Correct Answer: Cool, dry place away from humidity

Q11. Which polymer is a common non-gelatin alternative for hard capsule shells?

• Polyvinyl chloride (PVC)
• Hypromellose (HPMC)
• Polystyrene
• Polyethylene terephthalate (PET)

Correct Answer: Hypromellose (HPMC)

Q12. Which powder property most directly contributes to fill weight variability in capsule filling?

• Color intensity
• Flowability and compressibility
• pH of the powder
• Surface tension

Correct Answer: Flowability and compressibility

Q13. Visual inspection of capsules can identify which of the following defects?

• Cracks, discoloration, deformation and leakage
• Exact moisture content in ppm
• Detailed impurity profile by structure
• Residual solvent levels quantitatively

Correct Answer: Cracks, discoloration, deformation and leakage

Q14. Which test is used to detect microbial contamination in capsule batches?

• Friability test
• Microbial limit test (bioburden testing)
• Disintegration test
• Uniformity of dosage units by weight

Correct Answer: Microbial limit test (bioburden testing)

Q15. Insufficient sealing temperature during softgel manufacturing primarily causes:

• Over-hardening of the shell
• Leakage and poor hermetic seal
• Excessive plasticizer migration
• Increase in shell glass transition temperature

Correct Answer: Leakage and poor hermetic seal

Q16. Which analytical method is most suitable for accurate determination of moisture in capsule shells?

• Karl Fischer titration
• UV-Visible spectrophotometry
• Gas chromatography with flame ionization
• Nuclear magnetic resonance (NMR)

Correct Answer: Karl Fischer titration

Q17. Powder segregation during batching leads to which capsule defect?

• Improved uniformity of content
• Fill weight and content uniformity variation
• Faster dissolution uniformly
• Reduced microbial load

Correct Answer: Fill weight and content uniformity variation

Q18. What defect is indicated by powder adhering to the outer surface of a capsule?

• Soiling or powder picking
• Blooming
• Delamination
• Oversealing

Correct Answer: Soiling or powder picking

Q19. In the dye-leak test for softgels, which dye is commonly used as a tracer?

• Phenolphthalein
• Methylene blue
• Coomassie brilliant blue
• Rhodamine B

Correct Answer: Methylene blue

Q20. Controlling which parameter during manufacturing is most important to prevent both brittleness and tackiness of gelatin shells?

• Fill material pH
• Ambient and shell moisture content
• Capsule cap geometry only
• Type of lubricant used in tablet compression

Correct Answer: Ambient and shell moisture content

Q21. Improper cap-body fit leading to accidental opening during handling is primarily a problem of:

• Fill material hygroscopicity
• Dimensional tolerance and cap locking design
• Colorant migration
• Excessive drying of the fill

Correct Answer: Dimensional tolerance and cap locking design

Q22. Which manufacturing error can cause mottling and uneven finish on soft gelatin surfaces?

• Incorrect drying leading to surface crystallization of plasticizer
• Overfilling with powder
• Low gelatin bloom strength only
• High tablet compression force

Correct Answer: Incorrect drying leading to surface crystallization of plasticizer

Q23. Which quality test evaluates the amount of active pharmaceutical ingredient released from a capsule over time?

• Dissolution testing
• Disintegration testing
• Friability testing
• Moisture sorption analysis

Correct Answer: Dissolution testing

Q24. A common remedial action for fill weight variability observed during in-process checks is to:

• Increase capsule shell thickness
• Adjust the filling machine feed frame and improve powder flow
• Change the capsule color
• Reduce storage temperature to freezing

Correct Answer: Adjust the filling machine feed frame and improve powder flow

Q25. Which excipient property helps reduce sticking of powder to capsule shells during filling?

• High hygroscopicity
• Good glidant/lubricant addition to improve flow
• High electrostatic charging tendency
• Large particle size variability

Correct Answer: Good glidant/lubricant addition to improve flow

Q26. Shrinkage and deformation of gelatin capsules on storage are most likely caused by:

• Excessive exposure to light only
• Loss of moisture from the shell in low humidity
• High filler potency
• Excessive capsule locking

Correct Answer: Loss of moisture from the shell in low humidity

Q27. What manufacturing defect is indicated by partial melting or softening of softgel shells?

• Overdrying during conditioning
• Excessive heat during process or storage
• Incorrect capsule cap length
• Underlubrication of the filling pins

Correct Answer: Excessive heat during process or storage

Q28. Which control strategy reduces microbial contamination risk during capsule production?

• Open-air filling without segregation
• Implementing controlled cleanroom environment and GMP hygiene
• Avoiding any in-process testing
• Using unapproved colorants to inhibit microbes

Correct Answer: Implementing controlled cleanroom environment and GMP hygiene

Q29. During stability studies, an increase in capsule weight over time most likely indicates:

• Loss of fill by volatilization
• Moisture uptake by the capsule or fill
• Plasticizer permanently leaving the shell
• Reduced shell thickness from evaporation

Correct Answer: Moisture uptake by the capsule or fill

Q30. To troubleshoot frequent softening of gelatin shells, which immediate action is most appropriate?

• Increase production speed to finish batches faster
• Check and reduce local humidity and lower drying temperature
• Switch to metal capsule machines
• Add colorant to the shells to mask defects

Correct Answer: Check and reduce local humidity and lower drying temperature

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