Emea B1 Science Contamination And Sterility

8 Questions | Total Attempts: 77

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Emea B1 Science Contamination And Sterility

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Questions and Answers
  • 1. 
    Sterilization refers to a process that is used to eliminate (Select all that apply):
    • A. 

      Fungi

    • B. 

      Bacteria

    • C. 

      Viruses

    • D. 

      Spore forms

    • E. 

      Parasites

  • 2. 
    Sterilization methods include:
    • A. 

      Irradiation

    • B. 

      Heat

    • C. 

      Chemical

    • D. 

      All of the Above

  • 3. 
    The Sterility Assurance Level (SAL) describes the probability that a final product may have a microorganism present.
    • A. 

      True

    • B. 

      False

  • 4. 
    Aseptic technique refers to processing conditions that are closely controlled to reduce the potential for bacterial contamination.
    • A. 

      True

    • B. 

      False

  • 5. 
    USP <71> for sterility is (Select all that apply):
    • A. 

      A testing methodology

    • B. 

      Used to determine the presence or absence of microbes on a sampling of final products

    • C. 

      Is destructive testing of product

    • D. 

      Is a determination of terminal sterility of a finished product

  • 6. 
    USP <71> sterility tests and procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized.
    • A. 

      True

    • B. 

      False

  • 7. 
    Aseptic processing (Select all that apply)
    • A. 

      Can take a non-sterile material and make it sterile

    • B. 

      B. Can only provide assurance that the product does not become contaminated

    • C. 

      C. Is protection against additional contamination during manufacturing

    • D. 

      Cannot remove or kill microorganisms

  • 8. 
    1. Terminal sterilization…
    • A. 

      Allows for a STERILE label on a product

    • B. 

      Means the sterilization process has been validated

    • C. 

      Ensures ALL units within the process have the same probability of being sterile

    • D. 

      All of the Above

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