Facility & Equipment Selection for Tablets MCQs With Answer

Facility & Equipment Selection for Tablets MCQs With Answer

This quiz set is designed for M.Pharm students studying Scale Up & Technology Transfer (MIP 202T). It focuses on practical and regulatory aspects of selecting facilities and equipment for tablet manufacturing during scale-up: cleanroom classification, HVAC, containment, material flow, granulation and drying technologies, tablet presses and feeders, utilities, explosion protection, PAT and validation. Questions emphasize decision-making criteria such as process requirements, product properties, contamination control, maintenance, qualification and regulatory expectations. Use these MCQs to deepen understanding of how technical, operational and GMP considerations intersect when choosing equipment and designing facilities for robust, scalable tablet production.

Q1. What is the most important combined consideration when selecting a tablet press for scale-up from pilot to commercial production?

• Maximum turret diameter only
• Compression force range only
• Tooling compatibility only
• All of the above

Correct Answer: All of the above

Q2. Which ISO cleanroom classification is commonly recommended for tablet compression rooms with routine open-handling of non-sterile solids?

• ISO Class 5
• ISO Class 7
• ISO Class 8
• ISO Class 9

Correct Answer: ISO Class 8

Q3. The primary functions of HVAC in a tablet manufacturing area include which of the following?

• Temperature control only
• Humidity control only
• Particulate and differential pressure control only
• All of the above

Correct Answer: All of the above

Q4. Which material flow principle minimizes cross-contamination and is preferred in multiproduct tablet facilities?

• Unidirectional flow
• Random flow
• Cross-flow between suites
• Centralized chaotic flow

Correct Answer: Unidirectional flow

Q5. When choosing a granulation method during scale-up, which product attributes must be considered?

• Shear sensitivity
• Moisture sensitivity
• Compressibility and friability of the blend
• All of the above

Correct Answer: All of the above

Q6. Which piece of equipment is most appropriate for dry granulation at commercial scale?

• High-shear mixer-granulator
• Fluid bed dryer
• Roller compactor (dry granulator)
• Oscillating granulator

Correct Answer: Roller compactor (dry granulator)

Q7. For handling highly potent APIs during tableting, what containment approach is generally required?

• Open benches with PPE only
• Containment isolators or gloveboxes with closed transfer
• Standard laminar flow hood
• Local exhaust ventilation without isolation

Correct Answer: Containment isolators or gloveboxes with closed transfer

Q8. Explosion protection and ATEX considerations are most critical when what hazard exists in tablet production?

• Use of non-flammable liquids only
• Handling of fine combustible powder dust and pneumatic transfer
• Only when working with high-pressure gases
• When using stainless steel equipment exclusively

Correct Answer: Handling of fine combustible powder dust and pneumatic transfer

Q9. Which utility is essential for vacuum tray dryers and rotary vacuum equipment used in some tablet drying steps?

• Chilled water
• Compressed air
• Vacuum (vacuum pump/system)
• High-pressure steam only

Correct Answer: Vacuum (vacuum pump/system)

Q10. In equipment lifecycle documentation, what does SIP stand for?

• Start-up in place
• Sterilization-in-place
• Sanitation inspection procedure
• Systematized inventory planning

Correct Answer: Sterilization-in-place

Q11. Which PAT tool is commonly integrated inline or atline on tableting lines to monitor blend uniformity and moisture during scale-up?

• HPLC (offline)
• NIR spectroscopy (near infrared)
• Optical microscopy
• Thermogravimetric analysis (TGA)

Correct Answer: NIR spectroscopy (near infrared)

Q12. During scale-up of a rotary tablet press, which parameter most directly affects dwell time at the punch?

• Tooling hardness
• Turret diameter and rotational speed (therefore dwell time)
• Granule particle size alone
• Ambient humidity only

Correct Answer: Turret diameter and rotational speed (therefore dwell time)

Q13. For which of the following processes is a fluid bed dryer most suitable in tableting production?

• Dry granulation of moisture-sensitive APIs
• Drying wet granules and simultaneous granule conditioning
• Final compression of tablets
• Tooling maintenance

Correct Answer: Drying wet granules and simultaneous granule conditioning

Q14. High-speed continuous tablet production benefits most from which feeder type for consistent mass delivery?

• Volumetric screw feeder only
• Loss-in-weight feeder
• Manual gravity feed
• Vibratory tray without metering

Correct Answer: Loss-in-weight feeder

Q15. Which material of construction is generally preferred for product-contact parts in tablet manufacturing for corrosion resistance and cleanability?

• Aluminum
• 304 stainless steel
• 316L stainless steel
• PVC plastic

Correct Answer: 316L stainless steel

Q16. What is the primary objective of spatial and temporal segregation in a multiproduct solid dosage facility?

• To increase floor space utilization only
• To maximize worker travel time
• To prevent cross-contamination and minimize mix-ups
• To reduce HVAC costs only

Correct Answer: To prevent cross-contamination and minimize mix-ups

Q17. When scaling a high-shear granulator to preserve similar shear conditions on larger equipment, which scale-up rule is typically applied?

• Maintain constant power per unit volume
• Maintain constant impeller tip speed
• Maintain constant batch time regardless of size
• Maintain constant fill level only

Correct Answer: Maintain constant impeller tip speed

Q18. The purpose of a tablet deduster placed downstream of the tablet press is to:

• Compact tablets further
• Remove loose powder/dust and reduce airborne particulate on tablets
• Adjust tablet hardness
• Dry the tablet core

Correct Answer: Remove loose powder/dust and reduce airborne particulate on tablets

Q19. Which stage of equipment qualification demonstrates consistent performance under simulated production conditions at target scale?

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Design Qualification (DQ)

Correct Answer: Performance Qualification (PQ)

Q20. For moving powders between suites while minimizing contamination risk, which transfer method is preferred?

• Manual scooping through open doors
• Open tray transfer on trolleys
• Closed pneumatic or enclosed transfer with HEPA filtration and controlled interfaces
• Unfiltered vacuum transfer into the production room

Correct Answer: Closed pneumatic or enclosed transfer with HEPA filtration and controlled interfaces

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