Compounding: USP 28 Categories of Sterile Preparations

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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?

4 hours Signup and view all the answers

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

To reduce the risk of contamination Signup and view all the answers

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

2-8°C Signup and view all the answers

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

ISO Class 7 Signup and view all the answers

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

Sporicidal Agent Signup and view all the answers

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

Daily Signup and view all the answers

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

Monthly Signup and view all the answers

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

70% 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?

60 days 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?

12 hours Signup and view all the answers

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

-25°C 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?

28 days Signup and view all the answers

What attire is recommended for laboratory preparation?

Business casual or scrubs Signup and view all the answers

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

To inhibit the growth of microorganisms 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?

120 days Signup and view all the answers

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

To inhibit growth of microorganisms 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?

45 days Signup and view all the answers

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

60 days 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?

28 days Signup and view all the answers

What is the recommended attire for laboratory preparation?

Business casual or scrubs Signup and view all the answers

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

To prevent contamination of the compounded sterile preparations Signup and view all the answers

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

Category 3 Signup and view all the answers

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

4 hours Signup and view all the answers

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

30 seconds Signup and view all the answers

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

To minimize the risk of contamination during preparation Signup and view all the answers

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

To establish the level of environmental control required Signup and view all the answers

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

To remove residue and debris from gloves Signup and view all the answers

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

ISO Class 5 Signup and view all the answers

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

Daily and when contaminated Signup and view all the answers

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

Cleaning agent Signup and view all the answers

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

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

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

To minimize risk of airborne contamination of the compounding area Signup and view all the answers

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?

What type of gloves are required for garbing in a compounding facility?

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

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

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

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

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

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

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

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

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

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?

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?

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

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

What attire is recommended for laboratory preparation?

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

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?

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

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

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

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

What is the recommended attire for laboratory preparation?

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

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

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

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

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

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

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

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

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

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

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

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

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