PHRM 4200- Sterility Test With
Complete Solution
Can you always see bacterial contamination? - Answer no, has to be a large amount of
bacteria to see it
Do alcohol-based foams lead to sterility? - Answer no
What is the best way to have sterile hands? - Answer sterile gloves + alcohol spray
Should vials be cleaned? - Answer yes, wipe with alcohol before sterile compounding
What are the 3 main sources of contamination in sterile compounding? - Answer
materials, environment, personnel
How are airborne contaminants controlled? - Answer HEPA filtration, positive pressure
How are surface contaminants controlled? - Answer cleaning and sanitation
How are personnel contaminants controlled? - Answer training, monitoring, and testing
In what areas should personnel be tested? - Answer scrubbing, downing, hygiene,
workflow, aseptic technique
What are the 3 types of aseptic hoods? - Answer laminar flow, biological safety cabinet,
barrier isolator
What are the 4 methods of drug product sterilization? - Answer autoclaving, dry heat,
filtration, ionizing gamma radiation
autoclaving - Answer steam at 121-134C for 15min - will inactivate all fungi, bacteria,
viruses, spores
When is autoclaving used? - Answer for heat-stable aqueous solutions
What will autoclaving not eliminate? - Answer prions - infectious agent of protein
dry heat - Answer oven at >170C for much more than 15min
When is dry heat used? - Answer sealed glass and metal containers, powders
filtration - Answer 0.45-0.22 microm porosity sterile membranes
When is filtration used? - Answer for known heat-labile drugs and compounding when
heat stability is not known
When is ionizing gamma radiation used? - Answer powders, ointments, large
molecules/particles that can't be filtered
Complete Solution
Can you always see bacterial contamination? - Answer no, has to be a large amount of
bacteria to see it
Do alcohol-based foams lead to sterility? - Answer no
What is the best way to have sterile hands? - Answer sterile gloves + alcohol spray
Should vials be cleaned? - Answer yes, wipe with alcohol before sterile compounding
What are the 3 main sources of contamination in sterile compounding? - Answer
materials, environment, personnel
How are airborne contaminants controlled? - Answer HEPA filtration, positive pressure
How are surface contaminants controlled? - Answer cleaning and sanitation
How are personnel contaminants controlled? - Answer training, monitoring, and testing
In what areas should personnel be tested? - Answer scrubbing, downing, hygiene,
workflow, aseptic technique
What are the 3 types of aseptic hoods? - Answer laminar flow, biological safety cabinet,
barrier isolator
What are the 4 methods of drug product sterilization? - Answer autoclaving, dry heat,
filtration, ionizing gamma radiation
autoclaving - Answer steam at 121-134C for 15min - will inactivate all fungi, bacteria,
viruses, spores
When is autoclaving used? - Answer for heat-stable aqueous solutions
What will autoclaving not eliminate? - Answer prions - infectious agent of protein
dry heat - Answer oven at >170C for much more than 15min
When is dry heat used? - Answer sealed glass and metal containers, powders
filtration - Answer 0.45-0.22 microm porosity sterile membranes
When is filtration used? - Answer for known heat-labile drugs and compounding when
heat stability is not known
When is ionizing gamma radiation used? - Answer powders, ointments, large
molecules/particles that can't be filtered
