Compounding: USP 28 Categories of Sterile Preparations
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Questions and Answers

What is the minimum time required for hand washing with soap and water?

  • 15 seconds
  • 1 minute
  • 30 seconds (correct)
  • 2 minutes
  • What type of gloves are required for garbing in a compounding facility?

  • Latex gloves
  • Sterile powder-free gloves (correct)
  • Nitrile gloves
  • Cotton gloves
  • What is the highest level of environmental control in a compounding facility?

  • Category 4
  • Category 1
  • Category 2
  • Category 3 (correct)
  • What is the maximum time allowed for administration of an Immediate-Use CSP?

    <p>4 hours</p> Signup and view all the answers

    What is the purpose of low-lint gowns and shoe covers in a compounding facility?

    <p>To reduce the risk of contamination</p> Signup and view all the answers

    What is the minimum temperature requirement for refrigerated storage of compounded sterile preparations?

    <p>2-8°C</p> Signup and view all the answers

    What is the classification of air quality required for a sterile compounding facility's buffer room?

    <p>ISO Class 7</p> Signup and view all the answers

    What type of agent is used to destroy bacterial and fungal spores?

    <p>Sporicidal Agent</p> Signup and view all the answers

    How frequently should the Pass-Through LAFW (PEC) be cleaned and disinfected?

    <p>Daily</p> Signup and view all the answers

    What is the frequency of cleaning and disinfecting the walls and doors in a sterile compounding facility?

    <p>Monthly</p> Signup and view all the answers

    What is the concentration of isopropyl alcohol used for wiping critical sites in a sterile compounding facility?

    <p>70%</p> Signup and view all the answers

    What is the maximum number of days a Category 2 CSP can be stored in a controlled room temperature environment if it has undergone aseptic processing with sterility testing?

    <p>60 days</p> Signup and view all the answers

    What is the recommended duration for using a single-dose vial after initial entry, if it was entered in an ISO 5 or cleaner air environment?

    <p>12 hours</p> Signup and view all the answers

    What is the minimum temperature requirement for a freezer storage environment for CSPs?

    <p>-25°C</p> Signup and view all the answers

    What is the maximum number of days a multi-dose vial can be used after initial entry, assuming it contains a preservative?

    <p>28 days</p> Signup and view all the answers

    What attire is recommended for laboratory preparation?

    <p>Business casual or scrubs</p> Signup and view all the answers

    What is the primary purpose of having a preservative in a multi-dose vial?

    <p>To inhibit the growth of microorganisms</p> Signup and view all the answers

    What is the maximum beyond-use date for a Category 3 CSP that has undergone aseptic processing with sterility testing, and is stored in a controlled room temperature environment?

    <p>120 days</p> Signup and view all the answers

    What is the purpose of a preservative in a multi-dose vial?

    <p>To inhibit growth of microorganisms</p> Signup and view all the answers

    What is the maximum storage time for a Terminally Sterilized CSP with no sterility testing, stored in a freezer environment?

    <p>45 days</p> Signup and view all the answers

    What is the beyond-use date for an Aseptically Processed CSP stored in a refrigerator environment?

    <p>60 days</p> Signup and view all the answers

    What is the maximum time allowed for using a multi-dose vial after initial entry, assuming it contains a preservative?

    <p>28 days</p> Signup and view all the answers

    What is the recommended attire for laboratory preparation?

    <p>Business casual or scrubs</p> Signup and view all the answers

    What is the primary purpose of wearing low-lint attire in a compounding facility?

    <p>To prevent contamination of the compounded sterile preparations</p> Signup and view all the answers

    What is the highest level of environmental control in a compounding facility?

    <p>Category 3</p> Signup and view all the answers

    What is the maximum time allowed for administration of an Immediate-Use CSP?

    <p>4 hours</p> Signup and view all the answers

    What is the minimum time required for hand washing with soap and water in a compounding facility?

    <p>30 seconds</p> Signup and view all the answers

    What is the primary purpose of performing aseptic processing in a compounding facility?

    <p>To minimize the risk of contamination during preparation</p> Signup and view all the answers

    What is the primary purpose of categorizing compounded sterile preparations in a compounding facility?

    <p>To establish the level of environmental control required</p> Signup and view all the answers

    What is the primary purpose of using 0% isopropyl alcohol on gloves before entering the compounding area?

    <p>To remove residue and debris from gloves</p> Signup and view all the answers

    What is the classification of air quality required for a preparation of Class 1, 2, and 3 CSPs?

    <p>ISO Class 5</p> Signup and view all the answers

    What is the frequency of cleaning and disinfecting within the PEC and equipment?

    <p>Daily and when contaminated</p> Signup and view all the answers

    What type of agent is used to remove residues from surfaces?

    <p>Cleaning agent</p> Signup and view all the answers

    How should items be wiped before introducing them into the SEC and PEC?

    <p>With 70% IPA using low-lint wipes while wearing gloves</p> Signup and view all the answers

    What is the purpose of an anteroom with access to a positive-pressure buffer room?

    <p>To minimize risk of airborne contamination of the compounding area</p> Signup and view all the answers

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