Capsule Production Processes MCQs With Answer

Capsule Production Processes MCQs With Answer

This set of 20 targeted MCQs is designed for M.Pharm students preparing for MIP 203T – Pharmaceutical Production Technology. The questions focus on technical and practical aspects of capsule manufacture, including hard and soft capsule materials, capsule sizes, filling principles (dosator, tamping, piston and auger systems), machine operations, sealing and banding, moisture control, in-process controls, and common production defects. Each item presents four options and the correct answer for rapid self-assessment. These questions aim to deepen conceptual understanding, highlight critical process parameters, and help identify topics requiring further study for effective examination and practical competence in capsule manufacturing.

Q1. Which filling mechanism is most suitable for accurately dosing free-flowing powders into hard gelatin capsules at high speeds?

• Dosator system
• Tamping pin (tamp-fill) system
• Piston (volumetric) filler
• Auger filler

Correct Answer: Piston (volumetric) filler

Q2. The dosator system is especially advantageous when filling which type of formulation?

• Highly cohesive wet granules
• Molten liquids used for softgel encapsulation
• Powders with consistent compressibility and low cohesion
• Very fine, poorly flowing powders

Correct Answer: Powders with consistent compressibility and low cohesion

Q3. Which capsule material is preferred when a vegetarian, non-gelatin option with low moisture content is required?

• Gelatin
• Polyvinylpyrrolidone (PVP)
• Hydroxypropyl methylcellulose (HPMC)
• Sodium alginate

Correct Answer: Hydroxypropyl methylcellulose (HPMC)

Q4. Typical recommended moisture content for hard gelatin capsules to maintain mechanical integrity is approximately:

• 2–5%
• 7–9%
• 13–16%
• 25–30%

Correct Answer: 13–16%

Q5. Which in-process test specifically checks uniformity of weight for filled hard capsules according to pharmacopeial methods?

• Disintegration test
• Weight variation test
• Dissolution test
• Friability test

Correct Answer: Weight variation test

Q6. For powders that are highly cohesive and poorly flowing, which pre-filling operation is most commonly employed to improve flow?

• Spray drying without glidant
• Milling to ultrafine powder only
• Granulation (e.g., wet or dry granulation)
• Direct compression into pellets

Correct Answer: Granulation (e.g., wet or dry granulation)

Q7. Which capsule defect is typically caused by excessive humidity in the production area leading to capsule tackiness?

• Capsule brittleness
• Capping of cap and body separation
• Sticking or picking
• Chipping at the edges

Correct Answer: Sticking or picking

Q8. Banding or sealing of hard capsules is primarily used to:

• Improve dissolution rate
• Prevent tampering and reduce microbial contamination
• Make capsules more rigid for faster filling
• Change color for branding

Correct Answer: Prevent tampering and reduce microbial contamination

Q9. Which parameter is most critical to control when using a piston filler to ensure dose accuracy?

• Capsule color
• Ambient light intensity
• Piston stroke (volume) and fill depth
• Tablet hardness of auxiliary tablets

Correct Answer: Piston stroke (volume) and fill depth

Q10. In automatic capsule filling machines, which component is responsible for accurate orientation and separation of cap and body prior to filling?

• Dosator head
• Rotary capsule plate (or capsule feeding disc)
• Auger screw
• Punch and die assembly

Correct Answer: Rotary capsule plate (or capsule feeding disc)

Q11. Which filling technique is preferred for encapsulating coated pellets or mini-tablets to achieve uniform fill without damaging the units?

• Tamping pin method
• Dosator with sequential dosing
• Piston filler calibrated for pellets/granules
• Liquid pour filling into softgels

Correct Answer: Piston filler calibrated for pellets/granules

Q12. A common pharmacopeial dissolution performance issue with capsules can be caused by:

• Using capsules with appropriate moisture and compliant manufacturing
• Incorrect fill weight and inadequate capsule dissolution media
• Excessive glidant improving dissolution excessively
• Proper banding of capsules

Correct Answer: Incorrect fill weight and inadequate capsule dissolution media

Q13. Which excipient class when added in small amounts improves powder flow and reduces adhesion during capsule filling?

• Superdisintegrants
• Lubricants and glidants (e.g., magnesium stearate, colloidal silica)
• Preservatives
• Colorants

Correct Answer: Lubricants and glidants (e.g., magnesium stearate, colloidal silica)

Q14. During capsule production, cross-contamination risk is best minimized by:

• Increasing production speed only
• Using dedicated equipment, proper cleaning validation and containment
• Mixing different products on the same line without cleaning
• Storing raw materials together on the floor

Correct Answer: Using dedicated equipment, proper cleaning validation and containment

Q15. Which capsule size represents the largest volume among standard hard gelatin capsule sizes?

• Size 5
• Size 1
• Size 0
• Size 000

Correct Answer: Size 000

Q16. For liquid or semi-solid fills in hard capsules (e.g., specialized formulations), which technology is commonly used to secure the fill and prevent leakage?

• Immediate packaging without sealing
• Banding or sealing with gelatin or polymer bands
• Increasing capsule moisture to make it flexible
• Applying talc to the outside surface

Correct Answer: Banding or sealing with gelatin or polymer bands

Q17. Which environmental control is most important in the capsule filling area to maintain capsule integrity?

• Room color scheme
• Temperature and relative humidity control
• Soundproofing
• External lighting intensity

Correct Answer: Temperature and relative humidity control

Q18. The main difference between hard gelatin and soft gelatin capsules is:

• Hard gelatin capsules always release drug faster than softgels
• Soft gelatin capsules are a single-piece filled with liquid or semi-solid; hard capsules are two-piece shells filled with solid dose forms
• Hard gelatin capsules are used only for veterinary products
• Soft gelatin capsules are always made from HPMC

Correct Answer: Soft gelatin capsules are a single-piece filled with liquid or semi-solid; hard capsules are two-piece shells filled with solid dose forms

Q19. A common cause of double filling (two doses entering one capsule) on a high-speed capsule filling machine is:

• Excessive capsule drying prior to filling
• Poor hopper design, improper feed shoe or overly free-flowing powder without proper metering
• Appropriate use of a dosing disc
• Correct capsule orientation

Correct Answer: Poor hopper design, improper feed shoe or overly free-flowing powder without proper metering

Q20. Which quality attribute of hard capsules is typically evaluated by the disintegration test rather than friability?

• Resistance to mechanical shock during packaging
• Time required for the capsule shell to rupture and release contents in specified medium
• Powder bulk density inside the capsule
• Surface smoothness of the capsule shell

Correct Answer: Time required for the capsule shell to rupture and release contents in specified medium

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