Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 2 — Questions and Answers
Question 1: What is the key difference between a Biological Safety Cabinet (BSC) and a Laminar Airflow Workbench (LAFW)?
- A BSC uses horizontal airflow; a LAFW uses vertical airflow
- A BSC protects the operator from hazardous drug exposure; a LAFW does not (Correct answer)
- A LAFW has HEPA filtration; a BSC does not
- A BSC is used only for cytotoxics; a LAFW is used for all sterile preparations
Correct answer: A BSC protects the operator from hazardous drug exposure; a LAFW does not
A BSC protects both the sterile product and the operator/environment from hazardous drug aerosols by exhausting HEPA-filtered air away from the operator, while a LAFW only protects the product.
Question 2: What is the correct sequence for donning personal protective equipment (PPE) when entering a cleanroom?
- Gloves → gown → mask → shoe covers
- Shoe covers → head cover → mask → gown → gloves (Correct answer)
- Mask → gown → gloves → shoe covers
- Gown → gloves → shoe covers → mask
Correct answer: Shoe covers → head cover → mask → gown → gloves
Garbing proceeds from the floor upward — shoe covers first, then head cover, mask, gown — with gloves donned last, just before beginning aseptic work to minimize contamination of the hands.
Question 3: What is the primary purpose of environmental monitoring in a pharmacy cleanroom?
- To ensure proper temperature and humidity levels
- To verify ongoing microbiological quality of the compounding environment (Correct answer)
- To confirm HEPA filter efficiency ratings
- To measure lighting levels for accurate compounding work
Correct answer: To verify ongoing microbiological quality of the compounding environment
Environmental monitoring — both viable (microbial) and non-viable (particle) sampling — verifies that the cleanroom maintains microbiological quality necessary to produce sterile preparations consistently.
Question 4: Why is pyrogen (endotoxin) testing important for parenteral preparations?
- To detect bacterial cell wall components that cause fever and septic shock (Correct answer)
- To confirm the absence of all living microorganisms
- To measure preservative concentration in the preparation
- To verify the osmolality of the injectable solution
Correct answer: To detect bacterial cell wall components that cause fever and septic shock
Endotoxins are heat-stable lipopolysaccharide fragments from gram-negative bacterial cell walls that cause fever and septic shock; they persist even after sterilization kills all bacteria.
Question 5: Which intravenous solution is considered isotonic with human plasma?
- 0.45% sodium chloride (half-normal saline)
- 0.9% sodium chloride (normal saline) (Correct answer)
- 5% dextrose in water (D5W)
- 10% dextrose in water
Correct answer: 0.9% sodium chloride (normal saline)
0.9% sodium chloride has an osmolality of approximately 308 mOsm/kg, matching plasma osmolality and preventing red blood cell lysis or crenation upon intravenous administration.
Question 6: How long after first puncture should a multi-dose vial (MDV) be discarded, per standard pharmacy guidelines?
- 24 hours
- 48 hours
- 28 days (Correct answer)
- Until the manufacturer's expiration date
Correct answer: 28 days
USP and CDC guidelines recommend discarding multi-dose vials 28 days after initial puncture, unless the manufacturer specifies a shorter discard period, to minimize microbial contamination risk.
Question 7: Which grade of water is required by pharmacopeial standards for preparing parenteral (injectable) products?
- Distilled water
- Purified water
- Water for Injection (WFI) (Correct answer)
- Sterile drinking water
Correct answer: Water for Injection (WFI)
Water for Injection (WFI) meets strict USP standards for bacterial endotoxins, chemical purity, and sterility that are mandatory for all parenteral preparations.
Saudi Prometric Pharmacist Sterile Products and Aseptic Techniques 2
What is the key difference between a Biological Safety Cabinet (BSC) and a Laminar Airflow Workbench (LAFW)?