Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques

Question 1

What ISO classification corresponds to the critical zone (formerly Class 100) required during aseptic compounding?

Accepted Answer

ISO 5

Answer

ISO 5 corresponds to the former Class 100 designation, permitting no more than 3,520 particles ≥0.5 µm per cubic meter at the critical work site.

Question 2

Which filter pore size is classified as a sterilizing-grade filter for heat-labile solutions?

Accepted Answer

0.22 µm

Answer

A 0.22 µm (or 0.2 µm) membrane filter is the sterilizing-grade filter that retains bacteria and most microorganisms, achieving sterility for heat-labile solutions.

Question 3

What are the standard conditions for moist heat sterilization by autoclave?

Accepted Answer

121°C for 15 minutes

Answer

Standard autoclave sterilization uses saturated steam at 121°C (15 psi) for a minimum of 15 minutes to achieve a sterility assurance level of 10⁻⁶.

Question 4

Which biological indicator is used to validate moist heat (autoclave) sterilization?

Accepted Answer

Geobacillus stearothermophilus

Answer

Geobacillus stearothermophilus spores are the standard biological indicator for autoclave validation because of their exceptional resistance to moist heat.

Question 5

What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?

Accepted Answer

To maintain ISO 5 (Class 100) conditions at the critical work site

Answer

LAFWs supply unidirectional HEPA-filtered airflow across the work surface to maintain ISO 5 conditions, protecting sterile products from particulate and microbial contamination.

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques