Pharmacy Pharmacy Sterile Compounding 3

Question 1

What is the correct procedure for performing a media-fill test in sterile compounding?

Accepted Answer

Simulate the actual compounding process using a microbial growth medium instead of the drug

Answer

A media-fill test replicates the compounding process using soybean–casein digest (tryptic soy broth) media to assess whether a compounder's technique can introduce microbial contamination.

Question 2

A pharmacy technician accidentally touches the tip of a syringe needle during sterile compounding. What is the correct action?

Accepted Answer

Discard the needle, obtain a new one, and resume with proper technique

Answer

Any contact with a critical site such as a needle tip compromises sterility; the contaminated needle must be discarded and replaced before compounding continues.

Question 3

What is the significance of beyond-use dating (BUD) versus expiration dating for CSPs?

Accepted Answer

BUD is assigned based on preparation conditions and storage, while expiration dates are set by manufacturers

Answer

Expiration dates are determined by manufacturers through stability studies; BUDs are assigned by the compounder based on USP standards, preparation conditions, and stability data.

Question 4

Which cleanroom classification is required for an anteroom (ante-area) adjacent to an ISO Class 7 buffer room?

Accepted Answer

ISO Class 8

Answer

USP <797> requires that the ante-area adjacent to an ISO Class 7 buffer room maintain at least ISO Class 8 air quality to create an air pressure gradient that minimizes contamination.

Question 5

When compounding a total parenteral nutrition (TPN) solution, in what order should ingredients typically be added to minimize incompatibilities?

Accepted Answer

Amino acids and dextrose first, then lipids last if a 3-in-1 admixture

Answer

In TPN compounding, amino acids and dextrose are typically combined first to dilute electrolytes before adding lipids last in a 3-in-1 (total nutrient admixture) preparation to maintain emulsion stability.

Pharmacy Practice Test

Pharmacy Practice Test

Pharmacy Pharmacy Sterile Compounding 3