Isolator Technology WHO GMP
Questions 1. The primary benefit of isolator technology is:
A. Faster production
B. Reduced human labor costs
C. Decreased risk of microbial contamination
D. More ergonomic operation
Answer: C
Questions 2. Isolators help reduce contamination mainly by:
A. Increasing temperature
B. Limiting human interventions
C. Using disposable containers
D. Increasing product exposure
Answer: B
Questions 3. Isolators and transfer devices:
A. All have identical designs
B. Vary widely in design and configuration
C. Cannot include sterilization mechanisms
D. Are only made of stainless steel
Answer: B
Questions 4. Isolators are constructed of materials that:
A. Cannot ever leak
B. Are always puncture-proof
C. May differ in their susceptibility to puncture and leakage
D. Must be rigid metal
Answer: C
Questions 5. Transfer devices used with isolators may include:
A. Only single-door systems
B. Only double-door systems
C. Single-door, double-door, or fully sealed systems
D. Only systems without doors
Answer: C
Questions 6. One of the greatest potential contamination sources in isolator operation is:
A. Glove port size
B. Transfer of materials into and out of the unit
C. Air pressure changes
D. Operator posture
Answer: B
Questions 7. The inside of the isolator is generally considered:
A. A low-risk zone
B. A storage area
C. The local zone for high-risk manipulations
D. A non-sterile area
Answer: C
Questions 8. Unidirectional airflow inside isolators:
A. Always exists
B. Never exists
C. May not exist in all isolators and transfer devices
D. Is required by regulation in all designs
Answer: C
Questions 9. The background environment air classification for aseptic processing using isolators should be at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Questions 10. The required background air classification depends on:
A. Operator skill
B. The size of the isolator
C. The isolator design and its application
D. The cost of the system
Answer: C
Questions 11. Isolators should be introduced only after:
A. Operator training
B. Cleaning validation
C. Appropriate validation of the isolator technology
D. Installation of HEPA filters
Answer: C
Questions 12. Validation of an isolator should consider:
A. Air quality inside and outside the isolator
B. Color of the isolator walls
C. Noise levels during operation
D. Door lock speed
Answer: A
Questions 13. Which of the following is a critical factor in isolator validation?
A. Operator salary
B. Weather conditions
C. Sanitization of the isolator
D. Labeling of components
Answer: C
Questions 14. Isolator integrity tests should include:
A. Annual power consumption measurements
B. Routine leak testing
C. Paint quality inspection
D. Filter color checks
Answer: B
Questions 15. Monitoring of isolators should include frequent testing of:
A. Carpet fibers
B. Glove/sleeve system for leaks
C. Computer software
D. Operator productivity metrics
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products