Lecture 9 Flashcards
Parenteral Products (Pinal)
aseptic technique (AT)
manipulation of materials in such a way as to avoid accidental introduction of microorganisms
AT application
pharmacy
surgery
critical aspects of AT
proper personnel behavior
proper handling of gloves, syringes, vials, needles, ampuls, etc
ensure the sterility of the final product
AT practice
started in 1972
revisted in 1990
standards - 797 and 800
procedure that combines knowledge and manual skill
knowledge and manual skill
backbone of AT
either one without the other is insufficient
three sources of AT contamination
people (FIRST!)
equipment
environment
take care of environment?
control it
take care of equipment?
sterilize it
sanitize (disinfect) it
take care of people?
train them
garb them
develop the habit-forming skill
periodically test them
particle shedding by operators
motionless –> body motion –> body plus leg motion –> standing to sitting –> walking slow –> walking faster
USP <797>
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
pharmacist number of contaminations
2 of 2057
2 years of experience
technician number of contaminations
11 of 2000
5 years of experience
most important variablep
personnel
PEC
primary engineering control
laminar flow workbench (LAFW)
laminar flow
streamline flow of a fluid in which the fluid moves in layers without turbulence
occurs at low air velocities (around 100ft per min)
ISO Class 5
no more than 100 particles > 0.5 micron per cubic foot (or 3520 particles/cubic meter)
horizontal flow hoods
easier to work with comfortable
vertical flow hoods
must be used for hazardous (cytotoxic and vesicant) drugs
comfortable AT
falls in the oxymoron category
good training should make us confident, not comfortable
critical site
any point where microorganisms or other contamination could enter a parenteral product during compounding
direct compounding area (DCA)
critical area
space between the HEPA filter and the critical site
must keep uninterrupted laminar air flow in this area (first air)
laminar flow hood sterile?
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
first air
the air exiting the HEPA filter in a unidirectional air stream
from USP <797>
first air truths
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
