Non-Sterile to Sterile Compounding Flashcards

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 .