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

ISO 8 (Class 100,000)

Answer

ISO 7 (Class 10,000) only

Answer

ISO 9 (unclassified room)

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

To maintain positive air pressure only

Answer

To sterilise the final product by heat

Answer

To store ready-made IV preparations

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

Dry heat sterilisation at 160°C

Answer

Ethylene oxide gas sterilisation

Answer

UV radiation sterilisation

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

Viral contamination

Answer

Fungal spores

Answer

Particulate matter only

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

To maintain humidity for drug stability

Answer

To increase drug potency

Answer

To comply with temperature requirements only

Question 6

What is an 'expiry date' versus a 'beyond-use date' (BUD) in pharmacy compounding?

Accepted Answer

Expiry date is assigned by the manufacturer; BUD is the date after which a compounded or opened preparation must not be used

Answer

They are the same concept

Answer

BUD is always longer than the manufacturer's expiry date

Answer

Expiry dates apply only to generics