CSPT - Compounded Sterile Preparation Technician Non-Sterile to Sterile Compounding Questions and Answers 2

Question 1

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

Accepted Answer

Ensuring complete sterilization while maintaining chemical stability and potency

Answer

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

Question 2

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

Accepted Answer

Category 2

Answer

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

Question 3

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

Accepted Answer

Dissolution followed by 0.22-micron sterilizing filtration

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

CSPT - Compounded Sterile Preparation Technician Practice Test