exam 2 lecture 4

Question 1

aseptic technique

Answer 1

manipulating materials to avoid accidental introduction of microorganisms
applies to areas: pharmacy + surgery

Question 2

aseptic technique critical aspects

Answer 2

proper personnel behavior
proper handling of gloves, syringes, vials, needles, ampules
ensure sterility of final product

Question 3

three sources of contamination

Answer 3

environment - we control it
equipment - we sterilize and sanitize it
people - train, garb, development habits, periodical tests
most important is personel

Question 4

particles shed

Answer 4

motionless: 100,000
head, arm, neck, leg motion: 500,000
all above w/ foot motion: 1 mil
standing to sitting: 2.5 mil

Question 5

PEC

Answer 5

primary engineering control - laminar flow workbench
horizontal flow: easier to work with –> more comfortable
vertical flow: must be used for hazardous cytotoxic and vesicant drugs

Question 6

laminar flow hood

Answer 6

very clean but is not sterile
allows us to maintain sterility throughout CSP
clean environment –> not cleaning environment

Question 7

laminar flow

Answer 7

streamline flow of fluid which fluid moves in layers w/o turbulance – occurs at low air velocities
HEPA filtered: very clean air, ISO class 5: no more than 100 particles

Question 8

critical site

Answer 8

any point where microorganisms or other contamination could enter a parenteral product during compounding

Question 9

critical area

Answer 9

space between HEPA filter and critical site
must keep first air laminar flow in this area

Question 10

direct compounding area

Answer 10

area within LAFW where critical sites are exposed to HEPA filtered air

Question 11

First air

Answer 11

the air exiting the HEPA filter in a unidirectional air stream –> essentially particle free
air flow continously bathes critical site