DHA Pharmacist Sterile & Non-Sterile Preparations

Question 1

Which ISO cleanroom classification is required for the preparation of sterile injectable medications?

Accepted Answer

ISO 5 (Class 100) for the critical zone within a laminar airflow workbench

Answer

Sterile product compounding requires the critical working zone to be ISO 5 (Class 100), ensuring ≤100 particles ≥0.5 µm per cubic foot to prevent microbial and particulate contamination.

Question 2

What is the purpose of a biological safety cabinet (BSC) Class II in pharmacy aseptic compounding?

Accepted Answer

To protect both the operator and the product from hazardous drug contamination using vertical unidirectional airflow

Answer

A Class II BSC uses vertical laminar airflow and HEPA filtration to simultaneously protect the pharmacist from exposure to cytotoxic/hazardous drugs and maintain product sterility.

Question 3

Which sterilisation method is preferred for heat-stable aqueous injectable preparations?

Accepted Answer

Moist heat sterilisation (autoclaving at 121°C, 15 psi, 15–20 minutes)

Answer

Autoclaving uses saturated steam under pressure (121°C, 15 psi) to achieve the most reliable and validated sterilisation for heat-stable aqueous pharmaceutical preparations.

Question 4

What does the endotoxin (pyrogen) test in sterile preparation quality control detect?

Accepted Answer

Bacterial endotoxins (lipopolysaccharides from Gram-negative bacteria) that can cause fever and septic reactions

Answer

Endotoxin (pyrogen) testing using the Limulus Amebocyte Lysate (LAL) assay detects Gram-negative bacterial endotoxins that survive sterilisation and can cause severe febrile reactions when injected.

Question 5

Why must cytotoxic drug preparation be performed in a negative pressure environment?

Accepted Answer

To prevent hazardous drug aerosols from escaping the preparation area and exposing pharmacy staff

Answer

Negative pressure environments prevent hazardous aerosolised cytotoxic drug particles from being pushed out into the pharmacy, protecting staff from carcinogenic and mutagenic exposure.

DHA Pharmacist Practice Test

DHA Pharmacist Practice Test

DHA Pharmacist Sterile & Non-Sterile Preparations