Blow/fill/seal technology WHO GMP
Questions 1. Blow/fill/seal (BFS) units are designed to:
A. Only fill pre-formed containers
B. Form containers, fill, and seal them in one continuous operation
C. Sterilize containers separately
D. Only seal containers after manual filling
Answer: B
Questions 2. BFS equipment forms containers from:
A. Glass sheets
B. Thermoplastic granulate
C. Metal alloys
D. Pre-sterilized plastics
Answer: B
Questions 3. For aseptic production, BFS units fitted with an effective Grade A air shower may be installed in:
A. Grade A environment
B. Grade B environment
C. Grade C environment
D. Grade D environment
Answer: C
Questions 4. When BFS equipment is used for aseptic production in a Grade C environment, operators must wear:
A. Normal laboratory coats
B. Grade A or B clothing
C. Casual clothing
D. No special clothing is required
Answer: B
Questions 5. The environment for BFS equipment used for aseptic production should comply with:
A. Viable and non-viable limits at rest, and viable limits in operation
B. Only viable limits at all times
C. Only non-viable limits during operation
D. No environmental limits
Answer: A
Questions 6. BFS equipment for the production of terminally sterilized products should be installed in at least:
A. Grade A environment
B. Grade B environment
C. Grade C environment
D. Grade D environment
Answer: D
Questions 7. Particular attention in BFS technology should be paid to:
A. Operator salaries
B. Equipment design and qualification
C. Marketing strategies
D. Packaging aesthetics
Answer: B
Questions 8. Validation and reproducibility are required for:
A. Only filling operations
B. Cleaning-in-place (CIP) and sterilization-in-place (SIP)
C. Marketing and distribution
D. Shipping logistics
Answer: B
Questions 9. The background clean room environment is important because:
A. It affects the packaging color
B. It influences equipment operation and sterility assurance
C. It controls energy consumption
D. It reduces operator workload
Answer: B
Questions 10. Operator training and clothing are critical for:
A. Reducing production time
B. Ensuring aseptic operation in BFS technology
C. Reducing packaging material costs
D. Improving machine speed
Answer: B
Questions 11. Interventions in the critical zone of BFS equipment should be:
A. Frequent during operation
B. Minimized, especially before filling starts
C. Done without protective clothing
D. Encouraged for equipment adjustment
Answer: B
Questions 12. BFS technology combines which operations in a single machine?
A. Cleaning, inspection, and labeling
B. Forming, filling, and sealing
C. Sterilization, cooling, and packaging
D. Heating, molding, and labeling
Answer: B
Questions 13. For aseptic BFS equipment, which environmental grade is not required?
A. Grade C for installation
B. Grade A air shower
C. Grade D environment
D. Grade A or B clothing
Answer: C
Questions 14. The effective functioning of BFS equipment depends heavily on:
A. Internet connectivity
B. Machine design and proper qualification
C. Marketing approvals
D. Operator’s personal preferences
Answer: B
Questions 15. BFS equipment is especially sensitive to:
A. Container color
B. Interventions in the critical zone and aseptic assembly
C. Ambient noise
D. Shipping time
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products