Medication and Component Handling Flashcards

What is the correct technique for withdrawing medication from a single-dose vial?

Answer: Swab septum with 70% IPA, allow to dry, then insert needle using aseptic technique

The septum must be swabbed with sterile 70% IPA and allowed to dry completely before needle insertion.

How should ampules be opened to minimize the risk of glass particulate contamination?

Answer: Score if needed, wrap neck with alcohol pad, and snap away from the HEPA filter

Ampules should be scored, the neck wrapped with a sterile alcohol pad for protection, and snapped away from the HEPA filter.

What is the maximum time a multi-dose vial may be used after initial puncture according to USP 797?

Answer: 28 days unless otherwise specified by the manufacturer

Multi-dose vials may be used for up to 28 days after initial puncture unless the manufacturer specifies shorter dating.

When reconstituting a powdered drug, what must be verified before adding the diluent?

Answer: The correct diluent type, volume, and compatibility as specified by manufacturer or formulation record

Before reconstitution, verify the correct diluent type and volume as these are NOT interchangeable and affect drug stability and potency.

What is the purpose of performing a visual inspection of a completed CSP?

Answer: To detect visible particulate matter, discoloration, container-closure integrity issues, and confirm proper volume

Visual inspection detects particulate contamination, color changes, leaking or improperly sealed containers, and incorrect fill volumes.

How should ingredients be introduced into the PEC to maintain aseptic conditions?

Answer: Decontaminate outer surfaces with sterile 70% IPA, remove outer packaging in ante-area, and place items without blocking airflow

Components must have outer packaging removed in the ante-area, surfaces wiped with sterile 70% IPA, then placed in the PEC without blocking airflow.