CSPT Non-Sterile to Sterile Compounding 4

Question 1

When converting a non-sterile bulk powder to a sterile injectable, which sterilization method is preferred for heat-stable compounds?

Accepted Answer

Autoclaving (moist heat sterilization)

Answer

Autoclaving (moist heat) at 121°C for at least 15 minutes is the preferred terminal sterilization method for heat-stable compounded sterile preparations.

Question 2

A pharmacist determines that a non-sterile API cannot withstand heat sterilization. Which alternative sterilization method should be used?

Accepted Answer

Sterile filtration through a 0.22 µm filter

Answer

Sterile filtration through a 0.22 µm (or smaller) membrane filter is the standard alternative sterilization method for heat-labile compounds.

Question 3

Which documentation must be completed BEFORE beginning a non-sterile to sterile compounding process?

Accepted Answer

Master formulation record review and compounding record initiation

Answer

The master formulation record must be reviewed and a compounding record initiated prior to starting any compounding process to ensure accuracy and traceability.

Question 4

What is the primary purpose of conducting a filter integrity test (bubble point test) after sterile filtration?

Accepted Answer

To verify the filter membrane was not compromised during filtration

Answer

A post-filtration bubble point test confirms the filter membrane remained intact and was not ruptured, ensuring the filtration achieved sterilization.

Question 5

When dissolving a non-sterile powder for subsequent sterile filtration, which quality attribute of the solvent is critical?

Accepted Answer

The solvent must be sterile-grade or Water for Injection (WFI)

Answer

Sterile-grade solvents or Water for Injection must be used to minimize bioburden before final 0.22 µm sterile filtration.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Non-Sterile to Sterile Compounding 4