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

The bubble point test verifies membrane filter integrity by measuring the pressure at which air first breaks through a wetted filter, confirming that no bypass pathways exist that could allow microbial passage.

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

Terminal sterilization by autoclave in the final sealed container achieves a SAL of 10⁻⁶ and is preferred for heat-stable products because it sterilizes the product in its final packaging.

Question 3

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

Accepted Answer

Touching the needle shaft while preparing an injectable

Answer

Touching the needle shaft contaminates a critical site — any surface contacting the sterile product or fluid pathway — introducing microorganisms that can cause patient harm.

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

Lyophilization removes water from frozen solutions under vacuum, producing a stable dry powder that resists hydrolysis and oxidative degradation, dramatically extending the shelf life of moisture-sensitive biologics and drugs.

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

'First air' is uninterrupted HEPA-filtered airflow directly from the filter face that has not touched any non-sterile surface; critical sites must be bathed only in first air to prevent contamination.

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 3