Sterile and Non-sterile Compounding Flashcards

Under USP , how often must media-fill testing be performed for personnel compounding low- and medium-risk preparations?

Answer: At least annually

Media-fill testing to verify aseptic technique competency must be performed at least annually for low- and medium-risk compounding.

What does a media-fill test specifically evaluate?

Answer: The compounder's aseptic technique using microbial growth media

A media-fill test substitutes a sterile growth medium for drug to challenge and verify the operator's aseptic technique.

Per USP , the buffer area (where the PEC sits) should maintain what minimum ISO classification?

Answer: ISO Class 7

The buffer area housing the primary engineering control must be at least ISO Class 7.

Which order of garbing is correct when entering a sterile compounding area?

Answer: Shoe covers, head/facial covers, mask, then hand hygiene and gown

Garbing proceeds from dirtiest to cleanest: shoe covers, then head and facial hair covers and mask, followed by hand hygiene and the gown.

What is the appropriate hand antiseptic step immediately before donning sterile gloves in the anteroom?

Answer: Apply a waterless alcohol-based surgical hand scrub and let dry

After gowning, a persistent alcohol-based surgical hand antiseptic is applied and allowed to dry before donning sterile gloves.

Gloves used in sterile compounding should be disinfected with sterile 70% IPA at what point?

Answer: Before beginning and frequently throughout compounding

Sterile gloves must be sanitized with sterile 70% IPA before starting and regularly during compounding.

According to USP , what is the maximum BUD for a low-risk compounded sterile preparation stored at room temperature?

Answer: 48 hours

Low-risk CSPs may be stored at controlled room temperature for up to 48 hours under traditional default BUDs.