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usp
what sets the standards for compounding
simple
jsut following directions
moderate
involves specialized calculations or procedures or making a preparation that has no established stability data
complex
requires specialized training. equipment, facilities, or procedures
separated
non sterile compounding must be what from the dispensing part of the pharmacy
small volume parenteral
SVP
large volume parenteral
lvp
primary engineering control
pec
sterile hood that provides ISO 5 air for sterile compounding
laminar airflow work bench
lafw
type of sterile hood that has a parallel air strea, flow in one direction
containment pec
cpec
ventilated negative pressure chemo hood used for HDs
biological safety cabinet
bsc
chemo hood
secondary engineering control
sec
iso 7 buffer room where the sterile hood is located`
containment sec
csec
ventilated negative pressure buffer room for HDs
segrgated compounding area
sca
designated space that contains an ISO 5 hood that is not part of a cleanroom suite
compounding aseptic isolator
CAI
“glovebox” for non-HDs, a clsoed front sterile hood
compounding aseptic containment isolator
caci
“glovebox” for HDs, type of closed front PEC
restricted access barrier system
clsoed front sterile hood
-includes CAIs and CACIs
containment ventialted exposure
CVE
ventilated powder hood for non sterile products
lower
is it the lower or higher the particle count, the cleaner the air
8
the anteroom where garbing and hand washing occurs must be ISO what if it opens into a positive pressure (non sterile HD compounding)
7
the anteroom where garbing and hand washing occurs must be ISO what if it opens into a negative pressure ( sterile HD compounding)
postive
what air pressure for non hazardous compounding
negative
what air pressure for hazardous compounding
cleanroom suite
one or more sterile hoods (ISO 5 pecs) inside an iso 7 buffer room (SEC) that is entered through ant anteroom
negative
biological safety cabinets have what pressure and vertical laminar airflow
2
for sterile hazardous compounding, BSC must be what class
12
minimum air changes per hour for non sterile HDs or in a C-SCA
30
minimum air changes per hour in a sterile C SEC
-25 to -10
freezer temp for freezers only having CSPs
-50—15
freezer temp containing vaccines
30 minutes
how long for PEC or C PEC to be on before compounding can begin if it was turned off
top to bottom back to front
how to clean PEC
surfactant
this lowers the surface tension to make things more miscible
wetting agents
substances that reduce the surface tension between a liquid and a solid to permit the substance to more easily spread
emulsion
mixture of 2 or more liquids which are not able to be blended together
suspension
a solid dispersed in a liquid
levigating agents
this is used in levigation to aid in the grinding
-mineral oil or glycerin
trituration
grinding of particles wihtout the addition of a liquid
oxidation reduction, hydrolysis, photolysis
msot common chemical rxns that cause most drugs to become unstable and degrade
loses
a compound is oxidized when it gains or loses electrons
gains
a compound is reduced when it gains or loses electrons
binders
allows contects of a tablet to stick together
-provides stability and strenght
acacia, starch paste, sucrose syrup, compressible sugar
diluents
lactose, starches, calcium salts, cellulose
water, glycerin, alcohol
petrolatum, mineral oil, lanolin, waxes
these are used to bulk or make something more dilute
disintegrants
these facilitate the breakup of a tablet after oral admin
alginic acid, cellulose, polacrillin, starches
lubricants
these prevent ingredients from sticking to each other and euipment
magnesium stearate, colloidal silica, glycerin, mineral oil, talc
preservatives
do not use these in neonates
chlorhexidine, povidone iodine, BAK, sorbic acid, parabens, EDTA, thiomersal
humectants
these pull in water from the atmosphere to moisturize skin
glycerin, glycerol, propylene glycol, PEG, urea, hyaluronic acid
emulsifiers
these reduce the durface tension between 2 liquids
acacia, agar, PEG