Sterile Products and Aseptic Techniques Flashcards
7 cards from real SAUDI PROMETRIC PHARMACIST practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Sterile Products and Aseptic Techniques flashcards as text
What is the key difference between a Biological Safety Cabinet (BSC) and a Laminar Airflow Workbench (LAFW)?
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.
What is the correct sequence for donning personal protective equipment (PPE) when entering a cleanroom?
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.
What is the primary purpose of environmental monitoring in a pharmacy cleanroom?
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.
Why is pyrogen (endotoxin) testing important for parenteral preparations?
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.
Which intravenous solution is considered isotonic with human plasma?
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.
How long after first puncture should a multi-dose vial (MDV) be discarded, per standard pharmacy guidelines?
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.
Which grade of water is required by pharmacopeial standards for preparing parenteral (injectable) products?
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.
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