Single-Use Systems (SUS) & Closed systems EUGMP- Annex-1
Questions 1. Single-use systems (SUS) are used as an alternative to:
A. Terminal sterilization
B. Reusable equipment
C. Gowning systems
D. HVAC systems
Answer: B
Questions 2. SUS may consist of:
A. Only filters
B. Only sensors
C. Individual components or multiple components
D. Stainless-steel tanks
Answer: C
Questions 3. SUS should be designed to reduce:
A. Staff training
B. Need for manipulations and complexity of manual interventions
C. Documentation workload
D. Cleaning frequency
Answer: B
Questions 4. One risk associated with SUS includes:
A. Reduced sterility assurance
B. Interaction between product and contact surfaces
C. Excessive thermal resistance
D. Incompatibility with all media
Answer: B
Questions 5. The fragile nature of SUS compared with reusable systems represents:
A. A negligible concern
B. A specific risk that must be assessed
C. A benefit
D. A reason to avoid validation
Answer: B
Questions 6. SUS may increase:
A. Cleaning time
B. Number and complexity of manual operations
C. Need for metal components
D. Batch size
Answer: B
Questions 7. Complexity of SUS assembly is considered:
A. A minor inconvenience
B. A risk that must be assessed
C. A reason to avoid SUS entirely
D. Unrelated to contamination
Answer: B
Questions 8. SUS risk assessments must include:
A. Pre- and post-use integrity testing of sterilising grade filters
B. HVAC mapping
C. Raw material inventory
D. Operator performance only
Answer: A
Questions 9. A potential risk for SUS mentioned is:
A. Excessive humidity
B. Holes and leakage
C. Too many filter housings
D. Large batch sizes
Answer: B
Questions 10. Opening outer packaging may compromise SUS by introducing:
A. Temperature changes
B. Particle contamination
C. Noise
D. Pressure changes
Answer: B
Questions 11. Sterilisation processes for SUS should be:
A. Performed only by the user
B. Avoided
C. Validated and shown not to impact performance
D. Performed without documentation
Answer: C
Questions 12. Supplier assessment for SUS is:
A. Optional
B. Required only for reusable systems
C. Critical for proper selection and use
D. Done only after product complaints
Answer: C
Questions 13. For sterile SUS, evidence of sterilisation should be:
A. Ignored
B. Checked upon receipt
C. Verified annually
D. Sent to customers
Answer: B
Questions 14. Product adsorption and reactivity with contact surfaces must be:
A. Assumed negligible
B. Evaluated under process conditions
C. Tested only during cleaning validation
D. Avoided
Answer: B
Questions 15. Extractable and leachable profiles should be evaluated especially for:
A. Stainless-steel components
B. Polymer-based materials
C. Glassware
D. Metal fittings
Answer: B
Questions 16. Each SUS component should be assessed for:
A. Cost efficiency
B. Applicability of extractable profile data
C. Recyclability
D. Colour uniformity
Answer: B
Questions 17. High-risk components for leachables include those that:
A. Are made of steel
B. Absorb processed materials or have long contact times
C. Are used for less than one minute
D. Are only used for storage
Answer: B
Questions 18. Simulated processing conditions used for extractables testing must:
A. Be minimal
B. Be based on scientific rationale
C. Be the same for all SUS
D. Avoid reflecting actual conditions
Answer: B
Questions 19. SUS should maintain integrity:
A. Only during storage
B. Throughout processing under intended conditions
C. Only at room temperature
D. Only during transport
Answer: B
Questions 20. Structural integrity verification is important when SUS components:
A. Are used outdoors
B. Encounter extreme conditions like freezing or thawing
C. Are manufactured
D. Are used for visual inspection only
Answer: B
Questions 21. Intrinsic sterile connection devices must remain integral under:
A. Any lighting conditions
B. Extreme temperature conditions
C. Manual testing
D. Operator supervision
Answer: B
Questions 22. Acceptance criteria for SUS should be established based on:
A. Supplier preference
B. Cost
C. Risks and criticality of product and processes
D. Manufacturing speed
Answer: C
Questions 23. On receipt, each piece of SUS should be checked against:
A. The operator’s expectations
B. Approved specifications
C. Daily output requirements
D. Historical batch data
Answer: B
Questions 24. Visual inspection of SUS packaging should include checking:
A. Filter pore size
B. Outer carton appearance and pouch condition
C. Engineering drawings
D. Warehouse temperature
Answer: B
Questions 25. Documentation that must be reviewed before SUS use includes:
A. Marketing certificates
B. Certificates of conformance and proof of sterilisation
C. Shipping invoices
D. Batch reconciliation reports
Answer: B
Questions 26. The visual inspection of SUS must be:
A. Optional
B. Documented
C. Performed after use only
D. Skip-level approved
Answer: B
Questions 27. Critical manual handling operations of SUS should be:
A. Avoided entirely
B. Controlled appropriately
C. Performed only by supervisors
D. Done without training
Answer: B
Questions 28. Assembly and connections of SUS should be:
A. Performed without any checks
B. Verified during APS
C. Done only after sterilisation revalidation
D. Avoided if possible
Answer: B
Questions 29. Risk of particle contamination in SUS is:
A. Not relevant
B. One of the specific risks identified
C. Always eliminated by sterilisation
D. Only applicable to reusable systems
Answer: B
Questions 30. The CCS must include assessment of SUS risks because:
A. SUS are indestructible
B. Risks may affect product quality and sterility assurance
C. SUS always perform better than reusable systems
D. SUS remove the need for monitoring
Answer: B
Questions 31. The primary advantage of using closed systems is to:
A. Reduce the cost of operations
B. Reduce the risk of microbial, particle, and chemical contamination
C. Increase the need for manual manipulations
D. Eliminate the need for validation
Answer: B
Questions 32. Closed systems should be designed to:
A. Increase manual manipulations
B. Reduce the need for manual manipulations and associated risks
C. Only improve aesthetic appearance
D. Replace the need for sterile filtration
Answer: B
Questions 33. Ensuring sterility in closed systems involves:
A. Sterilizing only the background environment
B. Sterility of all product contact surfaces
C. Reducing the number of operators
D. Using unfiltered air in the system
Answer: B
Questions 34. Sterile equipment connections to the product pathway after the final sterilizing filter should be:
A. Connected aseptically using intrinsic sterile connection devices
B. Connected manually without any special precautions
C. Performed in an uncontrolled environment
D. Optional for polymer-based systems
Answer: A
Questions 35. Appropriate system integrity tests for closed systems should be performed:
A. Only if the system is new
B. When there is a risk of compromising product sterility
C. Only at the supplier site
D. Only for chemical stability studies
Answer: B
6. Supplier assessment for closed systems should include:
A. Only pricing information
B. Collation of data on potential failure modes leading to loss of system sterility
C. Marketing brochures
D. Operator training manuals
Answer: B
7. Closed systems used in aseptic processing should ideally be located in:
A. Grade D
B. Grade A
C. Office areas
D. Unclassified areas
Answer: B
8. If a closed system is shown to maintain integrity at every use, it may be located in:
A. A lower classified area, with proper assessment
B. A contaminated area
C. Outside the facility
D. Only in grade A areas
Answer: A
9. Opening a closed system for maintenance should be performed in:
A. Any unclassified area
B. A classified area appropriate to the materials
C. The operator’s office
D. A laboratory without classification
Answer: B
10. The CCS should capture:
A. The design, connection, and integrity measures of the closed system
B. Only the supplier name
C. Only the batch record numbers
D. Only the HVAC specifications
Answer: A
Reference – EU Guidelines for GMP- Annex-1