Cleanroom Environmental Classification, Controls And Certification; And Sterilization Controls And Monitors
5 Questions
| Total Attempts: 176
Questions and Answers
- 1.A Cleanroom is a defined space in which the concentration if airborne particles are controlled as necessary, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone.
- A.
True
- B.
False
- 2.The cleanroom and gowning room are clean zones that are certified per ISO 14644-1 to the requirements of:
- A.
Class 10
- B.
Class 2
- C.
Class 7
- D.
Class 8
- 3.Which of the following is not a method included in performing the environmental certification per this procedure?
- A.
Air Velocity
- B.
HEPA Filter Challenge
- C.
Room Dimensions
- D.
Airborne Particle Counts
- E.
Temperature and RH
- 4.What is the Action Level for the microbial monitoring of the cleanroom using the fallout plate?
- A.
25 CFU
- B.
26 CFU
- C.
5.0 CFU
- D.
76 CFU
- E.
10 CFU
- 5.How are sterilization activities controlled (check all that apply)?
- A.
Quarterly process parameter reviews
- B.
Sterilization adoptions
- C.
Validation testing
- D.
Sterilization run records reviews
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