Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 1 — Questions and Answers
Question 1: What ISO classification corresponds to the critical zone (formerly Class 100) required during aseptic compounding?
- ISO 4
- ISO 5 (Correct answer)
- ISO 7
- ISO 8
Correct answer: ISO 5
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?
- 1.0 µm
- 0.45 µm
- 0.22 µm (Correct answer)
- 0.1 µm
Correct answer: 0.22 µm
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?
- 100°C for 30 minutes
- 121°C for 15 minutes (Correct answer)
- 160°C for 2 hours
- 135°C for 5 minutes
Correct answer: 121°C for 15 minutes
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?
- Bacillus subtilis
- Geobacillus stearothermophilus (Correct answer)
- Clostridium perfringens
- Bacillus cereus
Correct answer: Geobacillus stearothermophilus
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?
- To protect the operator from hazardous drug exposure
- To maintain ISO 5 (Class 100) conditions at the critical work site (Correct answer)
- To filter room air before it enters the buffer area
- To provide negative pressure for containment of spills
Correct answer: To maintain ISO 5 (Class 100) conditions at the critical work site
LAFWs supply unidirectional HEPA-filtered airflow across the work surface to maintain ISO 5 conditions, protecting sterile products from particulate and microbial contamination.
Question 6: Which antiseptic agent is preferred for skin antisepsis before insertion of an intravenous catheter?
- Povidone-iodine 0.5%
- Isopropyl alcohol 70%
- Chlorhexidine gluconate 2% (Correct answer)
- Benzalkonium chloride 1%
Correct answer: Chlorhexidine gluconate 2%
Chlorhexidine gluconate 2% (often combined with isopropyl alcohol) is preferred for IV catheter insertion sites due to its broad-spectrum activity and persistent residual antimicrobial effect.
Question 7: What does the acronym HEPA stand for in cleanroom air filtration?
- High-Efficiency Particulate Air (Correct answer)
- High-Energy Particulate Arresting
- Humidity-Eliminating Purified Airflow
- High-Efficiency Pharmaceutical Aerosol
Correct answer: High-Efficiency Particulate Air
HEPA stands for High-Efficiency Particulate Air; these filters remove at least 99.97% of particles ≥0.3 µm from the airstream.
Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 1
What ISO classification corresponds to the critical zone (formerly Class 100) required during aseptic compounding?