Cleanroom Environmental Classification, Controls And Certification; And Sterilization Controls And Monitors

5 Questions | Total Attempts: 176

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Cleanroom Environmental Classification, Controls And Certification; And Sterilization Controls And Monitors - Quiz


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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