Podcast
Questions and Answers
According to USP General Chapter, which area is an ISO Class 8 or cleaner room with fixed walls and doors?
According to USP General Chapter, which area is an ISO Class 8 or cleaner room with fixed walls and doors?
ante-room
Hazardous medications must be compounded in a positive pressure room.
Hazardous medications must be compounded in a positive pressure room.
False (B)
Work in a LAFW should be performed within _____ of the edge.
Work in a LAFW should be performed within _____ of the edge.
6 inches
According to USP General Chapter, which of the following provides horizontal or vertical unidirectional HEPA-filtered airflow?
According to USP General Chapter, which of the following provides horizontal or vertical unidirectional HEPA-filtered airflow?
When drawing up solution into a syringe, the volume should not exceed ____ of the total syringe volume.
When drawing up solution into a syringe, the volume should not exceed ____ of the total syringe volume.
Before withdrawing solution from a vial, you should _____
Before withdrawing solution from a vial, you should _____
According to USP General Chapter, which of the following is a ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and a HEPA-filtered exhaust?
According to USP General Chapter, which of the following is a ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and a HEPA-filtered exhaust?
When using solution withdrawn from an ampule, you must _____
When using solution withdrawn from an ampule, you must _____
When inserting a needle into a vial, it should be _____
When inserting a needle into a vial, it should be _____
According to USP General Chapter, which area is an ISO Class 7 or cleaner room with fixed walls and doors?
According to USP General Chapter, which area is an ISO Class 7 or cleaner room with fixed walls and doors?
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Study Notes
Sterile Compounding and Aseptic Technique
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Ante-room: An ISO Class 8 or cleaner area with fixed walls and doors, essential for preparation and transition in sterile compounding.
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Compounding Conditions for Hazardous Medications: Hazardous medications must be compounded in a negative pressure environment, not a positive pressure room.
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Laminar Airflow Workbench (LAFW): Work should be conducted within 6 inches of the edge to ensure proper airflow and contamination control.
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Airflow in Compounding Areas: LAFWs provide horizontal or vertical unidirectional HEPA-filtered airflow, critical for maintaining aseptic conditions.
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Syringe Filling Guidelines: When drawing up solutions, the volume should not exceed 80% of the total syringe capacity to prevent contamination and ensure accuracy.
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Vial Withdrawal Technique: Before withdrawing a solution, inject air equal to the volume that will be extracted to avoid creating a vacuum in the vial.
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Class II Biological Safety Cabinet (BSC): A ventilated cabinet designed for hazardous compounding with open front and inward and downward unidirectional HEPA-filtered airflow.
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Ampule Handling: Must filter solutions withdrawn from ampules prior to injection to remove potential glass particles and ensure safety.
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Needle Insertion Angle: When inserting a needle into a vial, maintain a bevel up position at a 45-degree angle to facilitate smooth penetration and reduce contamination risk.
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Buffer Room: An area classified as ISO Class 7 or cleaner with fixed walls and doors, used for preparing sterile products and compounding hazardous materials.
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