Lecture 9

Question 1

aseptic technique (AT)

Answer 1

manipulation of materials in such a way as to avoid accidental introduction of microorganisms

Question 2

AT application

Answer 2

pharmacy
surgery

Question 3

critical aspects of AT

Answer 3

proper personnel behavior
proper handling of gloves, syringes, vials, needles, ampuls, etc
ensure the sterility of the final product

Question 4

AT practice

Answer 4

started in 1972
revisted in 1990
standards - 797 and 800
procedure that combines knowledge and manual skill

Question 5

knowledge and manual skill

Answer 5

backbone of AT
either one without the other is insufficient

Question 6

three sources of AT contamination

Answer 6

people (FIRST!)
equipment
environment

Question 7

take care of environment?

Answer 7

control it

Question 8

take care of equipment?

Answer 8

sterilize it
sanitize (disinfect) it

Question 9

take care of people?

Answer 9

train them
garb them
develop the habit-forming skill
periodically test them

Question 10

particle shedding by operators

Answer 10

motionless –> body motion –> body plus leg motion –> standing to sitting –> walking slow –> walking faster

Question 11

USP <797>

Answer 11

AT standard regarding personal hygiene and garbing
2004 and revisions
important note - squamous cells are normally shed from the human body at a rate of 10^6 or more per hour

Question 12

pharmacist number of contaminations

Answer 12

2 of 2057
2 years of experience

Question 13

technician number of contaminations

Answer 13

11 of 2000
5 years of experience

Question 14

most important variablep

Answer 14

personnel

Question 15

PEC

Answer 15

primary engineering control
laminar flow workbench (LAFW)

Question 16

laminar flow

Answer 16

streamline flow of a fluid in which the fluid moves in layers without turbulence
occurs at low air velocities (around 100ft per min)

Question 17

ISO Class 5

Answer 17

no more than 100 particles > 0.5 micron per cubic foot (or 3520 particles/cubic meter)

Question 18

horizontal flow hoods

Answer 18

easier to work with comfortable

Question 19

vertical flow hoods

Answer 19

must be used for hazardous (cytotoxic and vesicant) drugs

Question 20

comfortable AT

Answer 20

falls in the oxymoron category
good training should make us confident, not comfortable

Question 21

critical site

Answer 21

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

Question 22

direct compounding area (DCA)

Answer 22

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

Question 23

laminar flow hood sterile?

Answer 23

very clean environment –> but NOT STERILE
so clean that it allows us to maintain sterility throughout the CSP provided that we use proper (aseptic) technique
important - clean environment, not a cleaning environment

Question 24

first air

Answer 24

the air exiting the HEPA filter in a unidirectional air stream
from USP <797>

Question 25

first air truths

Answer 25

training started (correctly) with the idea of keeping the path free for the laminar airflow CONTINUOUSLY BATHING the critical site
BUT
training degenerated from keep path clear into the put the vial upside down