Sterile Compounding Flashcards

According to USP General Chapter, which area is an ISO Class 8 or cleaner room with fixed walls and doors?

Hazardous medications must be compounded in a positive pressure room.

Work in a LAFW should be performed within _____ of the edge.

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.

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?

When using solution withdrawn from an ampule, you must _____

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?

Sterile Compounding and Aseptic Technique

Ante-room: An ISO Class 8 or cleaner area with fixed walls and doors, essential for preparation and transition in sterile compounding.
Compounding Conditions for Hazardous Medications: Hazardous medications must be compounded in a negative pressure environment, not a positive pressure room.
Laminar Airflow Workbench (LAFW): Work should be conducted within 6 inches of the edge to ensure proper airflow and contamination control.
Airflow in Compounding Areas: LAFWs provide horizontal or vertical unidirectional HEPA-filtered airflow, critical for maintaining aseptic conditions.
Syringe Filling Guidelines: When drawing up solutions, the volume should not exceed 80% of the total syringe capacity to prevent contamination and ensure accuracy.
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.
Class II Biological Safety Cabinet (BSC): A ventilated cabinet designed for hazardous compounding with open front and inward and downward unidirectional HEPA-filtered airflow.
Ampule Handling: Must filter solutions withdrawn from ampules prior to injection to remove potential glass particles and ensure safety.
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.
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.

Test your knowledge on Sterile Compounding and Aseptic Technique as outlined in the USP General Chapter. These flashcards cover essential terms and definitions that are critical for understanding sterile environments in pharmacy practice.