CSPT - Compounded Sterile Preparation Technician Non-Sterile to Sterile Compounding Questions and Answers 2 — Questions and Answers
Question 1: What is the primary concern when converting a non-sterile ingredient into a sterile preparation?
- The cost of sterilization equipment
- Ensuring complete sterilization while maintaining chemical stability and potency (Correct answer)
- The ingredient taste after sterilization
- Whether the ingredient has been FDA approved
Correct answer: Ensuring complete sterilization while maintaining chemical stability and potency
The primary concern is achieving complete sterility without degrading the drug chemical properties.
The sterilization method must effectively eliminate all microorganisms while preserving the drug chemical integrity. For heat-stable drugs, autoclaving is the gold standard. For heat-labile drugs, sterilizing filtration is used.
Question 2: What category does a CSP made from non-sterile starting ingredients typically fall under in USP 797?
- Category 1
- Category 2 (Correct answer)
- It depends on the BUD assigned
- Not addressed by USP 797
Correct answer: Category 2
CSPs from non-sterile starting ingredients are typically Category 2 due to the inherently higher contamination risk.
Category 2 requires more stringent conditions including compounding in a fully compliant cleanroom suite, more rigorous environmental monitoring, and sterility testing requirements for extended BUDs.
Question 3: Which sterilization method is appropriate for a heat-labile drug solution?
- Autoclaving at 121 degrees C for 20 minutes
- Dry heat sterilization at 180 degrees C
- Dissolution followed by 0.22-micron sterilizing filtration (Correct answer)
- Ultraviolet light exposure for 30 minutes
Correct 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.
The drug must be fully dissolved since suspensions cannot be sterilized by filtration. Filter compatibility must be verified and filter integrity tested post-filtration.
Question 4: What is endotoxin testing and why is it important for non-sterile to sterile compounding?
- Testing for preservative levels
- Testing for bacterial endotoxins that cause fever and serious reactions even in sterile products (Correct answer)
- Testing the expiration date of raw materials
- Testing the osmolality of the solution
Correct 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.
Non-sterile to sterile compounding carries higher endotoxin risk because non-sterile ingredients may have significant bacterial bioburden. The LAL assay detects endotoxin levels.
Question 5: What documentation beyond standard CSP records is required for non-sterile to sterile compounding?
- No additional documentation needed
- Certificate of analysis for non-sterile ingredients, sterilization validation, and sterility testing results (Correct answer)
- Only a photo of the finished product
- The supplier marketing brochure
Correct 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.
The facility takes on the responsibility of achieving sterility, a function normally performed by pharmaceutical manufacturers with extensive quality systems.
Question 6: Why is a depyrogenation oven used in non-sterile to sterile compounding?
- To heat solutions before injection
- To render glassware free of pyrogens through dry heat at 250 degrees C or higher (Correct answer)
- To dry ingredients after washing
- To sterilize plastic containers
Correct 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.
The process achieves a minimum 3-log reduction in endotoxin levels. Plastic containers cannot be depyrogenated by this method as they would melt.
CSPT - Compounded Sterile Preparation Technician Non-Sterile to Sterile Compounding Questions and Answers 2
What is the primary concern when converting a non-sterile ingredient into a sterile preparation?