Non-Sterile to Sterile Compounding Flashcards

What is the primary concern when converting a non-sterile ingredient into a sterile preparation?

Answer: Ensuring complete sterilization while maintaining chemical stability and potency

The primary concern is achieving complete sterility without degrading the drug chemical properties.

What category does a CSP made from non-sterile starting ingredients typically fall under in USP 797?

Answer: Category 2

CSPs from non-sterile starting ingredients are typically Category 2 due to the inherently higher contamination risk.

Which sterilization method is appropriate for a heat-labile drug solution?

Answer: Dissolution followed by 0.22-micron sterilizing filtration

Heat-labile drugs are sterilized by dissolving in solvent and filtering through a 0.22-micron sterilizing filter.

What is endotoxin testing and why is it important for non-sterile to sterile compounding?

Answer: Testing for bacterial endotoxins that cause fever and serious reactions even in sterile products

Endotoxins are heat-stable and not removed by standard sterilization. They can cause fever, hypotension, and death if injected.

What documentation beyond standard CSP records is required for non-sterile to sterile compounding?

Answer: Certificate of analysis for non-sterile ingredients, sterilization validation, and sterility testing results

Non-sterile to sterile compounding requires additional documentation proving sterility was achieved.

Why is a depyrogenation oven used in non-sterile to sterile compounding?

Answer: To render glassware free of pyrogens through dry heat at 250 degrees C or higher

A depyrogenation oven destroys endotoxins on glassware through extended high-temperature dry heat.