Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 3

Question 1

What is the purpose of a bubble point test performed on sterilizing-grade membrane filters?

Accepted Answer

To verify filter integrity and confirm pore size before and after filtration

Answer

To measure the volumetric flow rate through the filter

Answer

To determine the microbial bioburden in the solution

Answer

To test for pyrogen contamination in the filtered product

Question 2

For a heat-stable ophthalmic solution, which sterilization method provides the highest sterility assurance level (SAL)?

Accepted Answer

Terminal sterilization by autoclaving

Answer

Filtration through a 0.22 µm filter

Answer

Gamma irradiation

Answer

Ethylene oxide treatment

Question 3

Which of the following actions constitutes a violation of aseptic technique?

Accepted Answer

Touching the needle shaft while preparing an injectable

Answer

Working at least 6 inches inside the laminar airflow workbench

Answer

Allowing unobstructed HEPA-filtered airflow over the critical site

Answer

Cleaning the LAFW surface with 70% isopropyl alcohol before use

Question 4

What is the primary advantage of lyophilization (freeze-drying) for sterile pharmaceutical products?

Accepted Answer

It improves long-term stability of moisture-sensitive drugs by removing water under vacuum

Answer

It eliminates the need for any cold-chain storage

Answer

It increases the aqueous solubility of the drug upon reconstitution

Answer

It significantly reduces the manufacturing cost compared to liquid formulations

Question 5

What does the term 'first air' mean in the context of aseptic compounding?

Accepted Answer

HEPA-filtered air that has not contacted any non-sterile surface before reaching the critical site

Answer

The initial air blown into the cleanroom when the HVAC system starts

Answer

The air from the anteroom used to positively pressurize the buffer zone

Answer

The air pressure differential maintained between cleanroom classification zones

Question 6

Which practice is correct when using a single-dose vial (SDV)?

Accepted Answer

SDVs must be discarded after use on a single patient, even if solution remains

Answer

SDVs may serve multiple patients if doses are drawn within 24 hours

Answer

SDVs can be pooled with other single-dose vials to reduce medication waste

Answer

SDVs can be stored and reused for up to 7 days after initial entry

Question 7

What ISO classification is required for the ante-room (support area) in a pharmacy cleanroom used for sterile compounding?

Accepted Answer

ISO 8

Answer

ISO 5

Answer

ISO 6

Answer

ISO 7