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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)