PTCE Sterile Preparations Flashcards
6 cards from real PTCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 PTCE Sterile Preparations flashcards as text
What is the correct order of garbing before entering a sterile compounding cleanroom?
Answer: Shoe covers, hair cover, face mask, gown, then sterile gloves last
Garbing proceeds from the feet up — shoe covers, hair cover, and face mask first, then gown, and sterile gloves are donned last just before beginning compounding.
What is 'touch contamination' in sterile compounding?
Answer: Direct contact of a critical site (e.g., needle tip or vial stopper) with a non-sterile surface
Touch contamination occurs when critical sites such as needle tips, syringe hubs, or vial stoppers contact non-sterile surfaces, introducing microorganisms into sterile preparations.
What ISO classification is required for the buffer room (anteroom area) where sterile compounding occurs?
Answer: ISO Class 7
USP 797 requires the buffer area (the room housing the LAFW) to maintain at least ISO Class 7 air quality to support the ISO Class 5 primary engineering control.
What is a pyrogen, and why is it significant in sterile compounding?
Answer: A fever-causing substance such as bacterial endotoxins that must be absent from sterile IV preparations
Pyrogens, most commonly bacterial endotoxins, can cause fever and septic shock when introduced intravenously, so sterile preparations must be pyrogen-free.
What is the purpose of garbing when entering a cleanroom?
Answer: To prevent the compounder from shedding microorganisms and contaminating sterile preparations
Humans naturally shed skin cells and microorganisms, so garbing with gown, gloves, mask, hair cover, and shoe covers creates a barrier to protect sterile products.
Which of the following best describes a low-risk compounded sterile preparation (CSP) under USP 797?
Answer: A CSP made using simple aseptic transfers of sterile ingredients in an ISO Class 5 environment
Low-risk CSPs involve simple aseptic manipulations of sterile ingredients and have the shortest assigned beyond-use dates due to minimal but possible contamination risk.