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USP Standards Pharmaceutical Compounding
Sterile Preparations
Randy Grekowicz,RPh; MBA Suzanne Lee, Pharm.D; RPh
Clinical Associate Professor Clinical Associate Professor
University of Washington, School of Pharmacy
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What is USP ? USP stands for United States
Pharmacopeia It is a non-government, non-profit
organization which is designed to createstandards on patient safety, healthcareinformation, and verification of products
specifically refers to sterilecompounding of pharmaceutics (i.e. IVadmixtures) in order to prevent patientharm
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Risk Level Classifications of
Compounded Sterile Products Risk level classifications are divided up
into low, medium, and high depending
on how much manipulation to theadmixture is involved
Low-risk level:
Manually mixing no more than threeproducts to compound drug admixtures
i.e. Morphine drip, Dopamine drip, KCl drip
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Risk Level Classification, cont. Medium-risk level:
Multiple individual doses of sterile products
are combined to prepare a product that willbe administered to multiple patients or thesame patients on multiple occasions
Compounding includes complex aseptic
manipulations other than single volumetransfer
i.e. TPN admixtures
Inpatient pharmacy normally practices at a
medium-risk level
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Risk Level Classification, cont. High-risk level:
Measuring or mixing sterile ingredients in
non-sterile devices before sterilization isperformed
Dissolving non-sterile bulk drug and
nutrient powders to make solutions, whichwill be sterilized
i.e. Cardioplegia drips
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Standard Operating Procedures Prior to entering the IV room:
Remove outer jackets, and jewelry (watches/rings) Long-sleeved shirts may NOT be worn
Personnel must comply to the cleaning and gowningpolicy (Hair bonnet, mask, gown, gloves, shoe covers) All additive containers must be swabbed with 70%
isopropyl alcohol Blowers of the laminar air hoods must operate
continuously
Supplies must be arranged aseptically within the hoodto minimize air flow turbulence At the end of compounding, discard all syringes and
needles in the sharps container All compounded products will be labeled properly
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Initial Garbing Mask
Masks must cover the nose and mouth
Hair bonnet
All hair must be contained within the haircover
Shoe covers
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Hand Washing Thoroughly wash hands, nails, and
arms up to the elbow with antiseptic
cleansing agent and water for 30seconds
Dry hands with a non-shedding towel
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Gowning for Sterile Compounding Cover gown must be donned
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After Gowning . . . Wear protective gloves
Gloves extend over the gown cuffs
Gloves should be sprayed with isopropylalcohol 70% and rubbed thoroughly
Allow gloves to air dry before
proceeding with sterile preparations
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Gloves Intermittently sterilize gloves with
isopropyl alcohol 70%
Change glove when torn, punctured, orcontaminated
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Chemotherapy/Biohazard Put on a disposable chemo gown and chemo
gloves prior to compounding a
chemotherapeutic or biohazard agent Make sure that the gloves extend over the cuff of
the gown
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Cleaning of Compounding Area Use isopropyl alcohol 70% to clean the
compounding area prior to the
beginning of each shiftAllow alcohol to remain for at least 30
seconds
Clean from back to front and top tobottom and avoid contact andcontamination of the HEPA filter
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Correct Hood Cleaning
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Incorrect Hood Cleaning
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Aseptic TechniqueA technique for manipulations of
compounded sterile products and
parenteral preparations that preventscontamination
Contamination sources: People
touch and airflow contamination
Air (via ventilation or air conditioning)
Infiltration (via adjacent rooms)
Internal generation (via walls, floors, ceilings)
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HEPA Filter High Efficiency Particulate Air (HEPA) filter
removes 99.97% of all air particles0.3microns or larger
It flows at a constant rate and physicallysweeps the work area and prevents the entryof contaminated air
Nothing should be permitted to come in
contact with the HEPA filter This includes cleaning solutions, aspirate from
syringes, sterile fluids
Break ampules away from the HEPA filter
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Air Flow Hoods Horizontal Flow (Laminar Flow Hood)
Air blows towards the personnel
Should be left operating continuously If it is turned off, it must be run for 30 minutes to
re-establish air flow and be cleaned before use
Vertical Flow (Chemotherapy Hood)
Air blows from top down
Should be left operating continuously
If it is turned off, it must be run for 4 hours to re-establish air flow and be cleaned before use
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Correct Placement of Items in
a Laminar Flow Hood
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Incorrect Placement of Items
in a Laminar Flow Hood
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Aseptic ManipulationAll sterile compounding inside the hood
should take place at least six inches into
the hood to prevent contamination fromthe room air
Only essential products should be in the
hood No paper, pens, calculators, or labels in the
hood
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Aseptic Technique, cont. Hand placement during aseptic manipulation
should be such that laminar airflow is notinterrupted around any of of the critical
sterile surface pathways
Talking or coughing should be directed awayfrom the hood to minimize contamination
No food or drink is allowed in the clean room
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Vials Swab the rubber top of the vial with an
alcohol prep using firm strokes in a
unidirectional sweeping motion at least3 times
Allow the alcohol to air dry
Inject an equal amount of air for thevolume of fluid to be removed toprevent vacuum formation
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Syringes Never touch the tip or plunger of the
syringe, this could lead to touch
contamination
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Syringes, cont. Syringes are available in sizes ranging
from 1 to 60 mL
In most cases, you should use thesmallest syringe possible to draw upyour complete volume; exception:
Chemotherapy
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Needles Needle size is determined by gauge and
length
Never touch any part of the needle Open needle packages within hood to
maintain sterility Peel open the needle wrapper
Tearing the paper introduces paper particles intothe hood, leading to contamination
Needles and syringes must be disposed of inthe sharps container
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Needles, cont. Coring: A core or hole in
the rubber top of the vial
To prevent coring, insertthe needle as shown
Insert the bevel tip first,then press downward andtoward the bevel so thatthe bevel tip and heelenter at the same point
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Ampules Clean the ampule neck with an alcohol
swab
Leave swab in place and grasp theampule neck
Use quick, firm, snapping motion away
from the body towards the side wall ofthe hood
Do NOT break ampule towards HEPAfilter
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Ampules, cont. To withdraw medication from the ampule:
Tilt ampule
Place needle bevel near opening of ampule No need to withdraw air first
Pull back on syringe plunger
Do NOT use a filter needle to remove ampulecontents
Use a filter needle to push contents out of thesyringe
Filter needles can only be used in one direction,otherwise glass particles originally filtered are
reintroduced
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Final Product Inspect final product after admixing to
look for precipitation, cores, or other
particulate matter
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Labeling requirements Patient name
Patient location
Drug name, strength, and amount
Diluent and volume
Route of administration
Beyond use date and time (Expiration)
Infusion rate
Compounders initials Pharmacists initials
Auxiliary label(s)
Bar code (whenever possible)