Sterile and Non-sterile Compounding Flashcards

Under USP , what type of facility ventilation is required for compounding hazardous drugs?

Answer: Externally vented, negative-pressure room with at least 12 air changes per hour

USP requires HD compounding rooms to be externally vented, negative pressure, with a minimum of 12 ACPH.

What does a closed-system transfer device (CSTD) accomplish when handling hazardous drugs?

Answer: Mechanically prohibits transfer of environmental contaminants in and escape of drug or vapor out

A CSTD prevents drug or vapor escape and blocks environmental contaminant entry during HD transfer.

Per USP , where should hazardous drugs be unpacked?

Answer: In a neutral or negative-pressure area, never in a positive-pressure space

HDs must be unpacked in a neutral/negative-pressure area to prevent contamination spread, not in positive-pressure rooms.

Which chemotherapy spill response item is essential and must be readily available in HD compounding areas?

Answer: A chemotherapy spill kit with appropriate PPE and absorbents

A dedicated chemotherapy spill kit with PPE, absorbent materials, and disposal bags must be available wherever HDs are handled.

What is the primary purpose of a low-lint, sterile wipe when cleaning the PEC?

Answer: Minimize particle and fiber shedding that could contaminate the sterile field

Low-lint wipes prevent fibers and particles from shedding into the ISO Class 5 environment.

When a TPN (total parenteral nutrition) admixture is compounded, why are calcium and phosphate added with caution?

Answer: They can form an insoluble calcium phosphate precipitate

Calcium and phosphate can combine to form insoluble calcium phosphate crystals, a serious incompatibility in TPN.

Under USP , gloves used when handling hazardous drugs should meet which standard?

Answer: ASTM D6978 chemotherapy-tested gloves

HD handling requires chemotherapy gloves tested per ASTM D6978 for permeation resistance.