Non-Sterile to Sterile Compounding Flashcards
7 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Non-Sterile to Sterile Compounding flashcards as text
When converting a non-sterile bulk powder to a sterile injectable, which sterilization method is preferred for heat-stable compounds?
Answer: Autoclaving (moist heat sterilization)
Autoclaving (moist heat) at 121°C for at least 15 minutes is the preferred terminal sterilization method for heat-stable compounded sterile preparations.
A pharmacist determines that a non-sterile API cannot withstand heat sterilization. Which alternative sterilization method should be used?
Answer: Sterile filtration through a 0.22 µm filter
Sterile filtration through a 0.22 µm (or smaller) membrane filter is the standard alternative sterilization method for heat-labile compounds.
Which documentation must be completed BEFORE beginning a non-sterile to sterile compounding process?
Answer: Master formulation record review and compounding record initiation
The master formulation record must be reviewed and a compounding record initiated prior to starting any compounding process to ensure accuracy and traceability.
What is the primary purpose of conducting a filter integrity test (bubble point test) after sterile filtration?
Answer: To verify the filter membrane was not compromised during filtration
A post-filtration bubble point test confirms the filter membrane remained intact and was not ruptured, ensuring the filtration achieved sterilization.
When dissolving a non-sterile powder for subsequent sterile filtration, which quality attribute of the solvent is critical?
Answer: The solvent must be sterile-grade or Water for Injection (WFI)
Sterile-grade solvents or Water for Injection must be used to minimize bioburden before final 0.22 µm sterile filtration.
A compounding technician is preparing a sterile ophthalmic solution from a non-sterile API. What tonicity adjustment is typically required?
Answer: The preparation should be isotonic (approximately 0.9% NaCl equivalent)
Ophthalmic preparations should be isotonic (equivalent to 0.9% NaCl) to prevent irritation and maintain patient comfort.
Under USP , which category of compounded sterile preparations (CSPs) requires the most stringent environmental monitoring and testing?
Answer: Category 2 CSPs intended for longer storage periods
Category 2 CSPs, which are assigned longer beyond-use dates, require the most stringent environmental monitoring, personnel qualification, and quality testing under USP .