CSPT Non-Sterile to Sterile Compounding 5 — Questions and Answers
Question 1: During non-sterile to sterile compounding, a technician notices visible particulate matter in the solution after reconstitution. What is the correct action?
- Filter the solution through a 5 µm filter and proceed
- Discard the preparation and document the discrepancy (Correct answer)
- Increase agitation to dissolve the particulate
- Adjust the pH to improve solubility and continue
Correct 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.
Question 2: Which endotoxin limit applies to intrathecal (intrathecal route) compounded sterile preparations according to USP guidelines?
- Less than 0.5 EU/mL
- Less than 0.2 EU/kg/hr based on patient weight and dose rate (Correct answer)
- Less than 5 EU/mL
- No endotoxin limit applies to intrathecal preparations
Correct 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.
Question 3: What is the significance of the 'overage' calculation when compounding a non-sterile API into a sterile preparation?
- Overage accounts for API degradation during sterilization to ensure label claim potency (Correct answer)
- Overage is added to compensate for filtration-related volume loss only
- Overage is calculated to increase the beyond-use date
- Overage eliminates the need for sterility testing
Correct 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.
Question 4: A pharmacist requests a sterile compounded preparation using a non-sterile excipient as a preservative. What must be verified before use?
- The excipient must have a Certificate of Analysis confirming identity, purity, and sterility grade (Correct answer)
- The excipient must be sourced from a local supplier only
- The excipient must be pre-filtered through a 0.45 µm filter by the compounder
- The excipient must be approved by the FDA as a new drug
Correct 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.
Question 5: Which personnel action is required immediately before beginning aseptic manipulations for a non-sterile to sterile compounding task?
- Apply lotion to prevent skin dryness under gloves
- Perform hand hygiene and don sterile gloves using aseptic technique (Correct answer)
- Wipe the ISO 5 hood surface with sterile water only
- Review the patient's medication administration record
Correct 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.
Question 6: 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?
- The powder's moisture content and its effect on potency (Correct answer)
- Only the labeled percentage of active ingredient in the powder
- The expiration date of the powder exclusively
- The country of origin of the raw material
Correct 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.
Question 7: Under USP <797>, 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?
- Continue compounding but increase monitoring frequency for 30 days
- Immediately cease compounding, quarantine affected CSPs, decontaminate, and investigate root cause (Correct answer)
- Discard only CSPs compounded in the last 24 hours and resume operations
- Notify the state board of pharmacy within 30 days and continue operations
Correct 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.
CSPT Non-Sterile to Sterile Compounding 5
During non-sterile to sterile compounding, a technician notices visible particulate matter in the solution after reconstitution.
What is the correct action?