CPhT Compounding 3

Question 1

Under USP <797>, which category of compounded sterile preparations (CSPs) has a permitted BUD of up to 45 days?

Accepted Answer

Category 2 CSPs stored at controlled cold temperature

Answer

Category 2 CSPs stored at controlled cold temperature (2–8 °C) may have a BUD of up to 45 days per USP <797> (2023 revision).

Question 2

Which ISO classification is required for the direct compounding area (DCA) when preparing sterile CSPs under a laminar airflow workbench (LAFW)?

Accepted Answer

ISO Class 5

Answer

The direct compounding area inside a LAFW must maintain ISO Class 5 (≤100 particles ≥0.5 µm per cubic foot).

Question 3

A technician adds 10 mL of a 50% dextrose solution to 90 mL of sterile water for injection. What is the final dextrose concentration?

Accepted Answer

5%

Answer

Dextrose mass = 10 mL × 0.50 = 5 g; final volume = 100 mL; concentration = 5 g/100 mL = 5%.

Question 4

When compounding a sterile preparation, which action BEST prevents touch contamination?

Accepted Answer

Keeping gloved hands downstream of critical sites

Answer

Keeping hands downstream (between the HEPA filter and the critical site) ensures unidirectional airflow sweeps over the critical site without contamination from hands.

Question 5

What is the purpose of a media-fill test in a sterile compounding pharmacy?

Accepted Answer

To qualify personnel aseptic technique using a microbial growth medium in place of the drug

Answer

Media-fill tests simulate the compounding process using trypticase soy broth to assess whether a compounder's technique introduces microbial contamination.

(CPhT) Certified Pharmacy Technician Practice Test

(CPhT) Certified Pharmacy Technician Practice Test

CPhT Compounding 3