PTCE Sterile Preparations Flashcards

What USP chapter governs the compounding of sterile preparations in US pharmacies?

Answer: USP 797

USP 797 sets standards for sterile compounding including environmental controls, personnel training, and beyond-use dating to prevent contamination and patient harm.

What is the ISO classification required for the primary engineering control (PEC) where sterile preparations are made?

Answer: ISO Class 5

ISO Class 5 is the cleanest required environment, maintained by the laminar airflow workbench (LAFW) or biological safety cabinet used during sterile compounding.

What is the primary purpose of a laminar airflow workbench (LAFW)?

Answer: To provide a sterile ISO Class 5 environment by passing air through a HEPA filter

The LAFW uses a HEPA filter to remove particles from air and direct it over the work surface in a unidirectional flow, creating a sterile compounding zone.

What is a beyond-use date (BUD) in sterile compounding?

Answer: The date after which a compounded sterile preparation should not be used

The BUD is assigned by the compounder and indicates the latest date/time the preparation should be administered, based on risk level and storage conditions per USP 797.

What is the correct direction for cleaning the laminar flow hood interior?

Answer: Back to front in overlapping side-to-side strokes using sterile 70% IPA

Cleaning from back to front prevents contaminated particles from flowing back over the clean work surface, and 70% IPA is the standard disinfecting agent.

What is aseptic technique in sterile compounding?

Answer: A set of practices designed to prevent microbial contamination during preparation of sterile products

Aseptic technique includes proper garbing, hand washing, LAFW cleaning, and handling critical sites without contamination to ensure sterile product integrity.