In-process quality control for sterile products MCQs With Answer

Introduction

This quiz collection focuses on in-process quality control for sterile products tailored for M.Pharm students. It highlights critical controls during aseptic manufacturing, covering environmental monitoring, process simulation (media fills), particulate and microbial air sampling, gowning and operator monitoring, pressure differentials, HEPA filter integrity, and sampling procedures. Questions emphasize practical criteria, regulatory expectations, and interpretation of alert/action limits, helping students apply theory to real-world sterile production. Use these MCQs to test and deepen understanding of contamination control strategies, in-process checks, documentation practices, and troubleshooting steps required to maintain sterility assurance during production of sterile pharmaceuticals.

Q1. Which of the following is the primary purpose of a media fill (process simulation) in aseptic production?

• To validate the sterilization cycle of terminally sterilized products
• To assess the microbial contamination risk from equipment cleaning procedures
• To simulate aseptic processing and demonstrate operator and process control
• To determine the endotoxin level in raw materials

Correct Answer: To simulate aseptic processing and demonstrate operator and process control

Q2. Which environmental parameter is most critical to maintain product sterility in Grade A (ISO 5) zones?

• Relative humidity
• Number of air changes per hour
• HEPA filter efficiency
• Airborne particulate count and unidirectional flow

Correct Answer: Airborne particulate count and unidirectional flow

Q3. When performing active air sampling in a sterile area, which method provides quantitative viable counts?

• Settle plates exposed for 4 hours
• Contact plate sampling of surfaces
• Impaction/volumetric air sampler that draws known volume of air onto agar
• Particle counter measuring non-viable particles

Correct Answer: Impaction/volumetric air sampler that draws known volume of air onto agar

Q4. Which is the appropriate action when environmental monitoring results exceed an established action limit?

• Ignore the result if still within historical trends
• Investigate root cause, quarantine product if indicated, and take corrective actions
• Immediately increase HVAC airflow without investigation
• Replace media used for sampling and repeat sampling next month

Correct Answer: Investigate root cause, quarantine product if indicated, and take corrective actions

Q5. Which of the following best describes an alert limit in environmental monitoring?

• A limit above which product must be discarded immediately
• A threshold indicating the need for investigation and increased monitoring
• The maximum allowed during media fill runs
• The same as the action limit defined by USP

Correct Answer: A threshold indicating the need for investigation and increased monitoring

Q6. In-process sterility checks for sterile filtration typically include which of the following tests?

• Integrity test of the sterilizing-grade filter (e.g., bubble point or diffusion test)
• Total organic carbon analysis of filtrate
• pH measurement only
• Endotoxin test on the filter housing exterior

Correct Answer: Integrity test of the sterilizing-grade filter (e.g., bubble point or diffusion test)

Q7. Which sampling method is most appropriate to monitor operator hands/gloves for viable contamination during aseptic processing?

• Swab sampling of glove surface followed by culture
• Particle counter measurement on gloves
• Air sampling around the operator
• ATP luminometer testing of the gown only

Correct Answer: Swab sampling of glove surface followed by culture

Q8. For Grade B background areas supporting aseptic filling, what is a typical acceptable airborne microbial limit for active air sampling per sample in many regulatory guidelines?

• 0 CFU per m3
• Less than or equal to 10 CFU per m3
• Less than or equal to 100 CFU per m3
• Greater than 1000 CFU per m3

Correct Answer: Less than or equal to 10 CFU per m3

Q9. Which non-viable particle size is most critical to monitor in sterile manufacturing because it can carry microorganisms?

• 0.1 µm
• 0.5 µm and larger
• 10 µm and larger
• Any particle below 0.01 µm

Correct Answer: 0.5 µm and larger

Q10. What is the best immediate corrective action if a daily air sampler in a cleanroom shows a sudden spike of viable counts during an aseptic run?

• Continue production but increase incubation time
• Stop operations, assess potential product impact, document event, and initiate investigation
• Turn off the HVAC system to allow counts to settle
• Only increase frequency of surface sampling next week

Correct Answer: Stop operations, assess potential product impact, document event, and initiate investigation

Q11. Which of the following is a commonly used disinfectant for daily cleaning of aseptic suites that is effective against spores?

• 70% isopropyl alcohol alone
• Peracetic acid or hydrogen peroxide vapor (sporicidal agents)
• Plain water
• Neutral detergent without sporicidal activity

Correct Answer: Peracetic acid or hydrogen peroxide vapor (sporicidal agents)

Q12. During in-process control of sterile product filling, what is the recommended approach for sampling in-process liquid for bioburden testing?

• Take samples only from final containers after sealing
• Use aseptic, validated sampling ports and perform membrane filtration or plate count methods
• Collect samples with open beakers from the filling line
• Only perform visual inspection instead of bioburden testing

Correct Answer: Use aseptic, validated sampling ports and perform membrane filtration or plate count methods

Q13. Which indicator(s) are commonly monitored during sterilizing filtration to ensure integrity prior to use in sterile production?

• Bubble point test and diffusion rate test
• Only color change indicators
• Endotoxin level of upstream solution
• Visual inspection of cartridge label

Correct Answer: Bubble point test and diffusion rate test

Q14. What is the primary reason for monitoring pressure differentials between cleanroom zones during sterile processing?

• To control temperature gradients
• To ensure directional airflow that prevents contamination ingress into higher-grade zones
• To measure relative humidity across zones
• To verify HVAC energy efficiency only

Correct Answer: To ensure directional airflow that prevents contamination ingress into higher-grade zones

Q15. Which parameter is essential to document for each media fill run to ensure regulatory compliance?

• Operator names, number of units filled, incubation conditions, and results of microbial recovery
• Only the batch number of media used
• Time of day when the run started but no environmental data
• Only the visual appearance of media

Correct Answer: Operator names, number of units filled, incubation conditions, and results of microbial recovery

Q16. In situ surface monitoring in aseptic areas commonly uses which technique for quantitative viable counts?

• Contact plates (RODAC) pressed onto surfaces
• Volumetric air samplers
• Optical particle counters
• pH indicator strips

Correct Answer: Contact plates (RODAC) pressed onto surfaces

Q17. What is the typical incubation program for bacterial recovery from environmental monitoring plates used in aseptic manufacturing?

• Incubate at 20–25°C for 48–72 hours only
• Incubate at 30–35°C for 5–7 days only
• Dual incubation at 20–25°C followed by 30–35°C for a total of 5–7 days
• Incubate at 60°C to detect thermophiles

Correct Answer: Dual incubation at 20–25°C followed by 30–35°C for a total of 5–7 days

Q18. Why is endotoxin testing important in in-process control for sterile parenteral products?

• To assess the viability of fungi in the product
• To detect pyrogenic lipopolysaccharides from Gram-negative bacteria that can cause febrile reactions
• To verify sterility of the final product
• To determine osmolarity of the formulation

Correct Answer: To detect pyrogenic lipopolysaccharides from Gram-negative bacteria that can cause febrile reactions

Q19. Which approach is considered best practice for monitoring non-viable particles during an aseptic filling operation?

• Run particle counters continuously at critical locations and log data for trending
• Measure particles only once per month
• Use settle plates as the sole method for particle monitoring
• Rely exclusively on visual inspection for dust

Correct Answer: Run particle counters continuously at critical locations and log data for trending

Q20. During an aseptic transfer into a Grade A zone, which practice minimizes contamination risk?

• Transferring via open pass-through without decontamination
• Using validated rapid transfer systems like pass-throughs with decontamination cycles or sterile isolators
• Hand-carrying materials through personnel doors during operations
• Leaving containers uncovered in the background area prior to transfer

Correct Answer: Using validated rapid transfer systems like pass-throughs with decontamination cycles or sterile isolators

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