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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