Maintenance, sanitation and sterile area management MCQs With Answer

Introduction:

This quiz collection on Maintenance, Sanitation and Sterile Area Management is designed specifically for M.Pharm students pursuing Quality Control & Quality Assurance. It covers core principles of cleanroom maintenance, sanitation procedures, HVAC and HEPA systems, cleaning validation, environmental monitoring, gowning practices, and documentation requirements under GMP. Questions emphasize application of knowledge to routine operations, troubleshooting, and regulatory compliance — helping students prepare for examinations and practical responsibilities in pharmaceutical sterile manufacturing. Detailed, scenario-based MCQs will reinforce understanding of critical controls that maintain sterility and product quality in controlled environments.

Q1. Which parameter is most critical to control in a Grade A (ISO 5) aseptic area to prevent contamination during open aseptic operations?

• Room temperature
• Airborne particle counts
• Relative humidity
• Lighting intensity

Correct Answer: Airborne particle counts

Q2. What is the primary purpose of HEPA filters in sterile area HVAC systems?

• To add humidity to the air
• To remove viable and non-viable particles ≥0.3 µm from the supply air
• To cool the supply air
• To neutralize chemical residues

Correct Answer: To remove viable and non-viable particles ≥0.3 µm from the supply air

Q3. During routine environmental monitoring, which method provides data on viable airborne microorganisms per cubic meter?

• Surface swab sampling
• Settle plates
• Active air sampling
• Particle counter

Correct Answer: Active air sampling

Q4. Which cleaning agent is most appropriate for routine terminal disinfection of stainless steel surfaces in a sterile production room when spike efficacy against spores is not required?

• Sodium hypochlorite (bleach) solution
• 70% isopropyl alcohol
• Quaternary ammonium compound
• Hydrogen peroxide vapor

Correct Answer: 70% isopropyl alcohol

Q5. What is the recommended minimum differential pressure between a Grade A workbench and the surrounding Grade B area to maintain airflow directionality?

• ≤ 2 Pa
• Approximately 5–15 Pa (positive into Grade A)
• 20–30 Pa
• Negative pressure of 10 Pa

Correct Answer: Approximately 5–15 Pa (positive into Grade A)

Q6. In cleaning validation for sterile areas, what is the most important outcome to demonstrate?

• Visual cleanliness only
• Absence of any detectable chemical residues by any method
• Consistent and reproducible removal of soil and microbial burden to predefined acceptance limits
• That cleaning is completed within a fixed time period

Correct Answer: Consistent and reproducible removal of soil and microbial burden to predefined acceptance limits

Q7. Which of the following best describes a “cleaning-in-place (CIP)” concept applied to aseptic equipment?

• Manual cleaning of parts disassembled outside the room
• Automated cleaning system that circulates detergents and sanitizers through equipment without disassembly
• Dry wiping of surfaces with sterile cloth
• Use of sporicidal fumigation only

Correct Answer: Automated cleaning system that circulates detergents and sanitizers through equipment without disassembly

Q8. Which environmental monitoring result would be most concerning for a Grade A zone during aseptic filling?

• Non-viable particle count slightly above operational limit for 0.5 µm
• No growth on settle plates after incubation
• Single repeatable colony detected by active air sampling during filling
• Low relative humidity readings

Correct Answer: Single repeatable colony detected by active air sampling during filling

Q9. For gowning in an aseptic area, what is the correct sequence to minimize contamination risk when entering a Grade A/B suite?

• Shoes → gloves → gown → face mask → hair cover
• Hair cover → face mask → gown → gloves (sterile) → shoe covers
• Gown → hair cover → face mask → gloves
• Gloves → gown → hair cover → face mask

Correct Answer: Hair cover → face mask → gown → gloves (sterile) → shoe covers

Q10. What is the main rationale for performing smoke studies (airflow visualization) in sterile areas?

• To count viable particles
• To verify actual airflow patterns and confirm unidirectional/laminar flow and absence of turbulence
• To sterilize work surfaces
• To measure filter integrity

Correct Answer: To verify actual airflow patterns and confirm unidirectional/laminar flow and absence of turbulence

Q11. Which monitoring practice is essential for validating HEPA filter performance over time?

• Periodic particle counting in supply air and DOP/PAO penetration testing during certification
• Measuring room temperature daily
• Visual inspection of pre-filters only
• Counting colony-forming units on surfaces weekly

Correct Answer: Periodic particle counting in supply air and DOP/PAO penetration testing during certification

Q12. When selecting a disinfectant for terminal cleaning, which property is least desirable for routine use in a sterile area?

• Broad-spectrum microbicidal activity
• Compatibility with stainless steel and plastics
• High corrosivity to critical surfaces
• Appropriate contact time and residue profile

Correct Answer: High corrosivity to critical surfaces

Q13. In the context of GMP, what is the purpose of a preventive maintenance program for sterile area equipment?

• To increase production speed irrespective of quality
• To ensure equipment reliability, reduce downtime, and prevent contamination risks due to failures
• To minimize the need for cleaning activities
• To allow unqualified personnel to perform repairs

Correct Answer: To ensure equipment reliability, reduce downtime, and prevent contamination risks due to failures

Q14. Which approach is most appropriate to confirm that a detergent residue will not interfere with microbiological or chemical assays used during cleaning validation?

• Assume dilution removes residue
• Use a validated neutralization or sampling method to detect residual detergent and demonstrate acceptance criteria
• Rely solely on visual inspection
• Use high temperature to volatilize residues

Correct Answer: Use a validated neutralization or sampling method to detect residual detergent and demonstrate acceptance criteria

Q15. What action should be taken if an aseptic area shows a sudden and sustained rise in non-viable particle counts during operations?

• Ignore if viable counts are acceptable
• Investigate root cause immediately, pause operations if necessary, and perform corrective actions such as filter check, gowning review, and cleaning
• Increase lighting to disperse particles
• Reduce the number of personnel without investigation

Correct Answer: Investigate root cause immediately, pause operations if necessary, and perform corrective actions such as filter check, gowning review, and cleaning

Q16. For surface monitoring in a Grade B area, which sampling method provides the most quantitative estimate of viable contamination?

• Contact plates (RODAC)
• Visual inspection
• Settle plates placed on floor
• ATP luminometer alone

Correct Answer: Contact plates (RODAC)

Q17. What is the significance of “terminal sterilization” vs “aseptic processing” when considering sterile area requirements?

• Terminal sterilization requires more stringent aseptic area controls than aseptic processing
• Aseptic processing requires stringent controlled environments (Grade A/B/C) and environmental monitoring; terminal sterilization sterilizes the final packaged product outside the cleanroom context
• They are identical in facility requirements
• Terminal sterilization avoids any need for microbial monitoring

Correct Answer: Aseptic processing requires stringent controlled environments (Grade A/B/C) and environmental monitoring; terminal sterilization sterilizes the final packaged product outside the cleanroom context

Q18. Which documentation is essential to demonstrate compliance with sanitation procedures in a sterile manufacturing unit?

• Verbal confirmation from operators
• Detailed SOPs, cleaning logs, validation records, and corrective action reports
• Only batch manufacturing records
• Supplier invoices for detergents

Correct Answer: Detailed SOPs, cleaning logs, validation records, and corrective action reports

Q19. Which method is most effective for sporicidal decontamination of a sealed sterile suite before maintenance or major interventions?

• 70% ethanol wiping
• Hydrogen peroxide vapor (HPV) fumigation
• Quaternary ammonium spray
• Dry air purging

Correct Answer: Hydrogen peroxide vapor (HPV) fumigation

Q20. In assessing cleaning frequency for various zones, which risk-based factor should primarily drive the cleaning schedule?

• Color of the walls
• Risk of product exposure and microbial contamination based on criticality of the area and operations performed
• Staff personal preference
• Time since last calibration of equipment

Correct Answer: Risk of product exposure and microbial contamination based on criticality of the area and operations performed

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