Compounding Personnel

8/12/2019 Compounding Personnel

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Compounding Personnel

Characteristics Trained

Competency-tested for aseptic technique

Must have basic understanding of microbiology

Understand good compounding practice


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Familiar in principles of sterilization(auto-claving or sterilization.

Knows the specifications for facilities and devices thperform (engineering principles)

Must understand the principles of environmental co


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TRAINING AND EVALUATINGCOMPOUNDING PERSONNEL:

Trainingis the most significant factor contributing to the assur

quality in sterile preparations.EXAMPLES: written exams, observations by a trained observer, mtesting and fingertip glove testing.

Since they are recognized as the primary source of contaminantor non viable), they should know how to control particulate sh

while compounding.


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Should be trained of proper hygiene( handwashing and wearingloves, etc.)

They should know that sterile preparations must have the highof quality and purity of all dosage forms.

Should be trained in selecting and using different facilities and for compounding.

Should learn methods in detecting viable microorganisms and these samples should be gathered and incubated and signifyingresults.

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Aseptic TechniqueLow-risk preparations:

-must be compounded in an ISO Class 5 air quality environment or better, from sterile ingredproducts, components, and devices. No more than three packages of sterile product can be more than two entries into any one of the sterile containers or packages can be made.

Example: an amiodarone (Cordarone) drip prepared by transferring the contents of one am900 mg vial into a glass bottle containing 500 mL of D5W.Medium-risk preparations:

-automated compounding devices for addition of small volume additives(e.g. TPN)

-Manipulations other than a single volume transfer are involved

-Unusually long duration of compounding process is involvedExamples: a bag of parenteral nutrition; a norepinephrine (Levophed) 16 mg/250 mL infusyou need to use four amps of norepinephrine 4 mg/4 mL.

High risk preparations:

-particularly exposed to the environment and to compounding personnel

-a non-sterile product is included, so that the preparation has to be sterilized.


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What is garbing?Garbingis the act of donning required PPE(Personal Protec

Equipment before compounding begins or before a worker e

particular controlled pharmacy compounding space (such asarea or the clean side of a compounding area).


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IMPORTANCE:TO PREVENT THE SHEDDING OF VIABLE AND NON-VIABLE PARTICLES FOF A COMPOUNDING PERSONNEL.

Humans are particle generators. Even though we cant see them, it is generally agreed thaabout 9 pounds of dead skin cells from the stratum corneum (the outer layer of the skin) per ye

What not to wear? No cosmetics or makeup of any

kind No jewelry on hands, neck and

head

No artificial nails or gel

nailschapter says natural nails

but does not explicitly say no nail

polish

No large expanses of exposed

skin (e.g. wearing of shorts or

skirts without hosiery)

No open toed shoes and shoes

worn without socks (such that

ankles and legs are exposed)


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Disposable masks ,head caps and lab gowns

Sterile gloves-disinfection of gloves by rubbing sterile 70% IPA

-should not have holes or punctures.

PROPER HYGIENE MUSTBE PERFORM

BEFORE ENTERING AND

WHEN LEAVING THE

BUFFER AREA!!!!!!


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Packaging and Labeling Container needs to be sterile and it should maintain the ste

the preparation to the beyond use date.

It should protect the preparation from chemical degradation

Containers should be compatible with the preparation.

The package should take into account the use of preparation


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PROPER LABELINGIDENTIFIES:

Medications,quantity,concentrations(doses) and expiration dates.

Supplementary informations(how to prepare,CI,indications,proper storage,e

*special techniques are use to highlight characteristics to avoid confusions.

Patient Specific Labeling includes:

Patient name and Identification number

Location

Name and amount of drugs added and the name of admixture solution Time and date of scheduled administration

Time and date of preparation

Administration instructions

Initials of the person who prepare the admixture

Documents

Compounding Personnel