Sterile Products and Aseptic Techniques Flashcards

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

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

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.

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

Answer: Terminal sterilization by autoclaving

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.

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

Answer: Touching the needle shaft while preparing an injectable

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

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

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

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.

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

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

'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.

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

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

Single-dose vials lack antimicrobial preservatives and are designed for one-time use on one patient; they must be discarded after a single puncture to prevent contamination-related infections.

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

Answer: ISO 8

The ante-room typically requires ISO 8 (formerly Class 100,000) classification, serving as a transitional buffer between uncontrolled corridors and the ISO 7 buffer zone where compounding equipment is located.