Blow-Fill-Seal EUGMP- Annex-1-Questions & Answers
Questions 1. BFS equipment for terminally sterilized products should be installed in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Questions 2. The point of fill in BFS equipment should comply with:
A. Paragraphs 8.3 and 8.4 environmental requirements
B. Only operator SOPs
C. Packaging specifications
D. Regulatory limits for storage
Answer: A
Questions 3. For shuttle-type BFS equipment, the parison is:
A. Always closed
B. Open to the environment
C. Sterilized after filling
D. Non-critical
Answer: B
Questions 4. Shuttle-type BFS critical zones should meet:
A. Grade C conditions
B. Grade B conditions
C. Grade A conditions for viable and total particles
D. Grade D conditions
Answer: C
Questions 5. Rotary-type BFS equipment parisons are generally:
A. Open to the environment
B. Closed to the environment once formed
C. Unmonitored
D. Sterilized only after filling
Answer: B
Questions 6. Rotary-type BFS equipment should be installed in at least:
A. Grade D environment
B. Grade C environment, provided grade A/B clothing is used
C. Grade B environment only
D. Grade A environment only
Answer: B
Questions 7. Microbiological monitoring of operators in a grade C BFS area should be performed:
A. Based on risk management principles
B. Never
C. Daily regardless of activity
D. Only after contamination events
Answer: A
Questions 8. In-operation monitoring of total particles for BFS equipment is:
A. Always required
B. Not expected due to particle generation from polymer extrusion
C. Optional for shuttle-type equipment
D. Required only for terminal sterilized products
Answer: B
Questions 9. Viable environmental monitoring of BFS processes should be:
A. Performed only after production
B. Risk-based and cover full duration of critical processing
C. Only for rotary-type BFS
D. Optional
Answer: B
Questions 10. Monitoring of the critical filling zone in rotary-type BFS equipment may:
A. Not be possible
B. Be optional for operators
C. Be done with total particle counters
D. Only apply to shuttle-type BFS
Answer: A
Questions 11. BFS environmental monitoring programmes should consider:
A. Only filter integrity
B. Moving parts, airflow paths, and high heat outputs
C. Operator comfort
D. Packaging design only
Answer: B
Questions 12. Air or gases contacting critical surfaces must undergo:
A. Cooling only
B. Appropriate filtration
C. No processing
D. Manual inspection
Answer: B
Questions 13. Polymer granulate contamination should be prevented by:
A. Random checks
B. Appropriate design, control, and maintenance
C. Operator hygiene only
D. Automated filling only
Answer: B
Questions 14. The sterility assurance of the extrusion system should be:
A. Ignored
B. Understood and validated
C. Verified only during validation
D. Optional for BFS
Answer: B
Questions 15. Raw polymer control includes:
A. Sampling frequency, bioburden, and endotoxin/pyrogen levels
B. Packaging only
C. Storage in unclassified areas
D. Operator checks only
Answer: A
Questions 16. Interventions requiring cessation of filling should be:
A. Avoided
B. Defined in the filling procedure and included in APS
C. Handled spontaneously
D. Documented only if contamination occurs
Answer: B
Questions 17. Controls identified during BFS qualification should align with:
A. Regulatory inspection schedule
B. Site’s CCS
C. Packaging SOP
D. Equipment manuals only
Answer: B
Questions 18. Critical zone boundaries for BFS are determined during:
A. Batch production
B. Qualification
C. Cleaning only
D. Operator training
Answer: B
Questions 19. BFS qualification environmental control considers:
A. Only the machine
B. Both the machine and the background environment
C. Packaging area only
D. Storage rooms only
Answer: B
Questions 20. BFS personnel gowning requirements should be:
A. Minimal
B. Defined and controlled
C. Optional in terminal sterilized products
D. Only gloves required
Answer: B
Questions 21. Integrity testing during BFS qualification includes:
A. Product filling lines and filtration systems
B. Packaging labels only
C. Manual inspections
D. Operator hygiene only
Answer: A
Questions 22. Critical process parameters for BFS include:
A. Cleaning-in-place and sterilisation-in-place of product pipelines
B. Operator breaks
C. Packaging design
D. Marketing approvals
Answer: A
Questions 23. Extrusion parameters to monitor in BFS include:
A. Temperature, speed, and extruder throat settings
B. Only operator settings
C. Packaging weight
D. Shipping conditions
Answer: A
Questions 24. BFS mould temperature monitoring is required for:
A. Cooling rates where necessary for product stability
B. Only visual checks
C. Only at the end of the batch
D. Optional for terminal sterilized products
Answer: A
Questions 25. Ancillary components (e.g., caps) should be:
A. Added randomly
B. Sterilized and added using a clean, controlled process
C. Stored in unclassified areas
D. Verified only post-production
Answer: B
Questions 26. Batch-specific testing for BFS should include:
A. Package wall thickness at critical points
B. Marketing labels
C. Shipping weight
D. Operator comfort
Answer: A
Questions 27. BFS operational procedures should describe:
A. Detection and rectification of blowing, forming, and sealing issues
B. Only cleaning procedures
C. Only packaging steps
D. None of the above
Answer: A
Questions 28. Addition of components to moulded containers in aseptic BFS should be performed under:
A. Grade B conditions
B. Grade A conditions using pre-sterilized components
C. Grade C conditions
D. Unclassified conditions
Answer: B
Questions 29. Maintenance procedures for BFS should include:
A. Inspection and maintenance plans for items critical to sealing, integrity, and sterility
B. Cleaning only
C. Packaging only
D. Marketing approvals
Answer: A
Questions 30. Any changes or modifications to BFS moulds should trigger:
A. Operator discretion
B. Assessment of container integrity and validation if required
C. No action if production is ongoing
D. Only cleaning verification
Answer: B
Reference – EU Guidelines for GMP- Annex-1