Controls in sterile packaging processes MCQs With Answer

This quiz set on “Controls in Sterile Packaging Processes” is designed for M.Pharm students preparing for advanced quality control and assurance roles. It covers critical aspects such as sterile barrier systems, container closure integrity, environmental controls, packaging material selection, sealing validation, and post-sterilization handling. Questions emphasize practical controls, testing methods (e.g., helium leak, vacuum decay), validation protocols (IQ/OQ/PQ), and regulatory expectations to ensure sterility and shelf-life. Use these MCQs to deepen understanding of risk points in aseptic and terminally sterilized products, identify common failure modes, and reinforce best practices for maintaining sterility assurance throughout packaging operations.

Q1. Which test is considered most sensitive for detecting microscale leaks in parenteral container closures used for sterile products?

• Dye ingress test
• Pressure/vacuum decay test
• Water bath submersion (bubble emission) test
• Helium leak detection

Correct Answer: Helium leak detection

Q2. What is the primary purpose of a sterile barrier system (SBS) in pharmaceutical packaging?

• To provide aesthetic appeal to the product
• To protect product from mechanical damage during shipping
• To prevent microbial ingress and maintain sterility throughout shelf-life
• To act as the primary labeling surface

Correct Answer: To prevent microbial ingress and maintain sterility throughout shelf-life

Q3. During seal integrity validation of pouches used for terminally sterilized items, which parameter is most critical to monitor?

• Seal color uniformity
• Seal width and seal strength (peel/seal strength)
• Surface gloss of the pouch
• Ambient humidity in the warehouse

Correct Answer: Seal width and seal strength (peel/seal strength)

Q4. Which environmental control is most essential in an aseptic filling area to reduce the risk of airborne contamination?

• Temperature control to ±5°C
• Positive differential pressure with HEPA-filtered laminar airflow
• Humidity above 80% RH
• Use of fluorescent lighting only

Correct Answer: Positive differential pressure with HEPA-filtered laminar airflow

Q5. What does SAL (Sterility Assurance Level) of 10^-6 indicate for a sterilization process?

• One in a million probability that a viable microorganism remains on a sterilized item
• Six microorganisms are always present after sterilization
• Six logs of microbial increase during storage
• Sterility will be maintained for six months

Correct Answer: One in a million probability that a viable microorganism remains on a sterilized item

Q6. Which of the following is the best method to assess container closure integrity for lyophilized vials intended for aseptic filling?

• Dye ingress with methylene blue
• High-voltage leak detection (HVLD)
• Visual inspection under bright light
• Microbial challenge test without instrumentation

Correct Answer: High-voltage leak detection (HVLD)

Q7. Which packaging material property is most important when designing packaging for gamma-irradiated sterile products?

• High oxygen permeability
• Radiation resistance and minimal change in mechanical properties
• Bright color pigments to indicate sterilization
• High water retention capacity

Correct Answer: Radiation resistance and minimal change in mechanical properties

Q8. In an aseptic filling line, what is the primary control to prevent particle generation from equipment?

• Use of non-shedding materials and scheduled preventive maintenance
• Frequent change of labels on product containers
• Applying lubricants liberally during operation
• Operating at low temperatures only

Correct Answer: Use of non-shedding materials and scheduled preventive maintenance

Q9. Which of the following indicators is appropriate to confirm that a load has been exposed to steam sterilization at the required temperature and time?

• Process indicator tape that only changes color when exposed to any heat
• Biological indicator containing spores of Geobacillus stearothermophilus
• Visual label indicating operator presence
• Methylene blue dye within the package

Correct Answer: Biological indicator containing spores of Geobacillus stearothermophilus

Q10. Which control is most effective for reducing recontamination risk during transfer of sterile products from filling to secondary packaging?

• Open transfer through a laminar flow hood in the corridor
• Use of validated sterile transfer system or isolator with controlled transfer locks
• Manual transfer by operators wearing only hairnets
• Sealing product in boxes immediately in non-classified area

Correct Answer: Use of validated sterile transfer system or isolator with controlled transfer locks

Q11. What is the principal rationale for performing accelerated aging studies on sterile-packaged pharmaceuticals?

• To determine packaging aesthetics after long-term storage
• To estimate chemical stability and packaging performance over shelf-life under stressed conditions
• To encourage early market release
• To evaluate ease of opening by patients

Correct Answer: To estimate chemical stability and packaging performance over shelf-life under stressed conditions

Q12. Which validation stage specifically verifies that the packaging equipment performs effectively under simulated routine production conditions?

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

Correct Answer: Performance Qualification (PQ)

Q13. Which of these is a common root cause of peelable pouch seal failures observed during routine quality checks?

• Incorrect artwork on the pouch
• Contaminated sealing jaws or inconsistent sealing temperature/pressure/time
• Using thicker film than specified always improves seals
• Low inventory levels of pouches

Correct Answer: Contaminated sealing jaws or inconsistent sealing temperature/pressure/time

Q14. For aseptically filled sterile products, which in-process control is critical to maintain sterility during filling?

• Intermittent depressurization of fill room
• Volume checks of labels applied
• Continuous monitoring of viable particle counts and airflow patterns
• Allowing doors to open frequently for convenience

Correct Answer: Continuous monitoring of viable particle counts and airflow patterns

Q15. What is the most appropriate approach to validate a sealing process for heat-sealed blister packs containing sterile tablets?

• Only visual inspection of a few samples
• Develop and qualify critical process parameters and perform statistical sample testing for seal integrity and peel strength
• Rely on operator training without documented limits
• Seal at maximum temperature to ensure permanent bond

Correct Answer: Develop and qualify critical process parameters and perform statistical sample testing for seal integrity and peel strength

Q16. Which microbial control measure should be applied to packaging materials entering a sterile filling area?

• Materials can be placed directly without inspection
• Pre-sterilization or validated sanitization, quarantine, and environmental monitoring before entry
• Only labels should be sanitized
• Use of untreated corrugated cardboard inside the cleanroom

Correct Answer: Pre-sterilization or validated sanitization, quarantine, and environmental monitoring before entry

Q17. Which non-destructive test is suitable for routine batch-level container closure integrity screening of single-use prefilled syringes?

• Dye ingress destructive destruction
• High-voltage leak detection (HVLD) or Vacuum decay non-destructive methods
• Complete destruction and culture of all syringes
• Colorimetric pH test of container surface

Correct Answer: High-voltage leak detection (HVLD) or Vacuum decay non-destructive methods

Q18. When assessing packaging for sterile biologics sensitive to oxygen, which packaging control is most critical?

• Use of oxygen scavengers, low oxygen-permeable materials, and O2 headspace control
• Brightly colored outer cartons
• Large headspace to facilitate mixing
• Rely only on foil without qualification

Correct Answer: Use of oxygen scavengers, low oxygen-permeable materials, and O2 headspace control

Q19. Which documentation is essential to demonstrate control of sterile packaging during regulatory inspection?

• Only manufacturing purchase orders
• Validated procedures, batch records, CCI data, environmental monitoring, and change control records
• Employee CVs only
• Unsigned rough notes from operators

Correct Answer: Validated procedures, batch records, CCI data, environmental monitoring, and change control records

Q20. In packaging for terminally sterilized products, what is the impact of residual ethylene oxide (EO) on the packaged drug and what control is required?

• No impact; EO residues are irrelevant
• EO residuals can be toxic and reactive; validated aeration and residual limit verification are required
• EO makes the product sterile indefinitely without need for testing
• EO only affects packaging color and needs no control

Correct Answer: EO residuals can be toxic and reactive; validated aeration and residual limit verification are required

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