Non-Sterile to Sterile Compounding Flashcards

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

Answer: Discard the preparation and document the discrepancy

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

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

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

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.

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

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

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

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

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

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

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

Answer: Perform hand hygiene and don sterile gloves using aseptic technique

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

When preparing a sterile batch from a non-sterile powder, the compounder must perform calculations to determine the quantity of powder needed. Which factor must be accounted for?

Answer: The powder's moisture content and its effect on potency

The powder's moisture content (loss on drying) affects its true potency, and calculations must account for water content to deliver the correct amount of active ingredient.

Under USP , how must a compounding facility respond if environmental monitoring cultures reveal growth of a high-risk microorganism (e.g., Burkholderia cepacia) in the ISO 5 area?

Answer: Immediately cease compounding, quarantine affected CSPs, decontaminate, and investigate root cause

Discovery of a high-risk organism in the ISO 5 compounding area requires immediate cessation of compounding, quarantine of potentially affected preparations, full decontamination, and root cause investigation.