Non-Sterile to Sterile Compounding Flashcards

What is the role of Water for Injection (WFI) in non-sterile to sterile compounding?

Answer: Serves as the primary vehicle for dissolving non-sterile ingredients with strict pyrogen and microbial limits

WFI meets stringent USP purity standards including endotoxin limits suitable for parenteral preparations.

What is a pre-sterilization bioburden assessment?

Answer: Quantifying the microbial load before sterilization to ensure processes will be effective

A pre-sterilization bioburden assessment measures the microbial contamination level to validate the sterilization method capacity.

Which method is most reliable for verifying sterility of a CSP made from non-sterile ingredients?

Answer: Incubation-based sterility testing using USP-specified methods

Incubation-based sterility testing is the definitive method for confirming the CSP is free of viable microorganisms.

What quality controls should be performed on non-sterile bulk drug powder before use?

Answer: Identity testing, Certificate of Analysis review, visual inspection, and verification against USP monograph

Non-sterile bulk ingredients require identity testing, CoA review, visual inspection, and USP monograph verification.

What is the significance of the sterility assurance level (SAL)?

Answer: It represents the probability of a single viable microorganism surviving after sterilization, typically 10 to the negative 6 or better

A SAL of 10 to the negative 6 means less than one in a million chance that a viable microorganism survives.

What is the main advantage of autoclaving over filtration for sterilizing non-sterile preparations?

Answer: Autoclaving kills endospores and reduces endotoxins, while filtration only removes organisms physically

Autoclaving kills all microorganisms including endospores and reduces endotoxin levels. Filtration only physically removes organisms and does not affect endotoxins.