CSPT Non-Sterile to Sterile Compounding 5

Question 1

During non-sterile to sterile compounding, a technician notices visible particulate matter in the solution after reconstitution. What is the correct action?

Accepted Answer

Discard the preparation and document the discrepancy

Answer

Any preparation with visible particulate matter must be discarded, as it fails visual inspection criteria and poses a patient safety risk.

Question 2

Which endotoxin limit applies to intrathecal (intrathecal route) compounded sterile preparations according to USP guidelines?

Accepted Answer

Less than 0.2 EU/kg/hr based on patient weight and dose rate

Answer

Intrathecal CSPs have the most stringent endotoxin limit of 0.2 EU/kg/hr because the blood-brain barrier does not protect against endotoxins administered directly into the CSF.

Question 3

What is the significance of the 'overage' calculation when compounding a non-sterile API into a sterile preparation?

Accepted Answer

Overage accounts for API degradation during sterilization to ensure label claim potency

Answer

Overage is added to account for drug degradation during sterilization processes (e.g., autoclaving) so the final product meets its labeled potency.

Question 4

A pharmacist requests a sterile compounded preparation using a non-sterile excipient as a preservative. What must be verified before use?

Accepted Answer

The excipient must have a Certificate of Analysis confirming identity, purity, and sterility grade

Answer

All non-sterile ingredients used in CSP compounding must have a Certificate of Analysis (CoA) verifying identity, purity, and suitability for sterile preparation.

Question 5

Which personnel action is required immediately before beginning aseptic manipulations for a non-sterile to sterile compounding task?

Accepted Answer

Perform hand hygiene and don sterile gloves using aseptic technique

Answer

Proper hand hygiene followed by donning sterile gloves using aseptic technique is required immediately before any aseptic manipulation to prevent contamination.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Non-Sterile to Sterile Compounding 5