Aseptic Processing and Sterilization by Filtration WHO GMP
Question 1. The main objective of aseptic processing is to:
A. Reduce product cost
B. Maintain sterility of assembled components
C. Improve product color
D. Increase viscosity
Answer: B
Question 2. Aseptic processing must operate under conditions that:
A. Encourage microbial growth
B. Prevent microbial contamination
C. Maximize airflow
D. Reduce temperature
Answer: B
Question 3. Maintaining sterility during aseptic processing requires attention to:
A. Only personnel
B. Environment, personnel, critical surfaces, procedures, holding period, filters
C. Packaging design only
D. Only temperature
Answer: B
Question 4. Components must be sterilized:
A. Before aseptic assembly
B. After final packaging
C. Only after filtration
D. Only if liquid
Answer: A
Question 5. Liquids that cannot be sterilized in their final container should be:
A. Rejected
B. Filtrated through a sterile 0.22-micron filter
C. Stored for 24 hours
D. Heated to boiling
Answer: B
Question 6. Sterile 0.22-micron filters can remove:
A. All viruses
B. Mycoplasmas
C. Bacteria and moulds
D. Prions
Answer: C
Question 7. Filtration alone is NOT sufficient when:
A. Heat sterilization is impossible
B. Sterilization in final container is possible
C. Product is light-sensitive
D. Product is a powder
Answer: B
Question 8. Preferred method of sterilization when possible:
A. UV irradiation
B. Steam sterilization
C. Filtration only
D. Dry heat
Answer: B
Question 9. Due to added risks, filtration may require:
A. Only a single filter
B. Double filtration or second sterilized filter layer
C. Heating after filling
D. No validation
Answer: B
Question 10. Final sterile filtration should occur:
A. At any convenient point
B. Before transferring to warehouse
C. As close as possible to the filling point
D. In a separate building
Answer: C
Question 11. Filters used in aseptic processing must have:
A. High fiber shedding
B. Minimal fiber shedding (virtually zero)
C. Asbestos content
D. Disposable outer layers
Answer: B
Question 12. Asbestos-containing filters are:
A. Acceptable with validation
B. Allowed only for gases
C. Never allowed
D. Allowed for powders
Answer: C
Pharmaceutical Quality System (PQS)
Question 13. Filter integrity must be verified:
A. Only once a year
B. Before use and confirmed immediately after use
C. Only after sterilization
D. Only for gases
Answer: B
Question 14. Acceptable filter integrity test methods include:
A. Density test
B. Viscosity test
C. Bubble point, diffusive flow, pressure hold
D. Evaporation test
Answer: C
Question 15. Significant differences in filtration time or pressure during manufacturing must be:
A. Ignored
B. Corrected automatically
C. Noted and investigated
D. Accepted as variability
Answer: C
Question 16. Results of filter integrity checks must be included in:
A. Equipment manual
B. Purchase order
C. Batch record
D. SOP index
Answer: C
Question 17. Integrity of gas and air vent filters must be confirmed:
A. Only before use
B. Only once monthly
C. After use
D. Every three years
Answer: C
Question 18. A filter may be used for more than one working day only if:
A. It has been validated for extended use
B. It is cleaned properly
C. It has a metal housing
D. It passes a bubble point test
Answer: A
Question 19. Filters must not affect the product by:
A. Changing the temperature
B. Removing or releasing substances
C. Changing product color
D. Speeding up filling time
Answer: B
Question 20. Validation must determine:
A. Filter color
B. Filtration time for a known volume and required pressure
C. Operator preference
D. Container label design
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products