Compounding Personnel

Characteristics
Trained Competency-tested for aseptic technique Must have basic understanding of microbiology

Understand good compounding practice

Familiar in principles of sterilization(auto-claving or hot air sterilization. Knows the specifications for facilities and devices they must perform (engineering principles) Must understand the principles of environmental conditions

TRAINING AND EVALUATING COMPOUNDING PERSONNEL:

Training is the most significant factor contributing to the assurance of
quality in sterile preparations. EXAMPLES: written exams, observations by a trained observer, media fill testing and fingertip glove testing. Since they are recognized as the primary source of contaminants(viable or non viable), they should know how to control particulate shedding while compounding.

 Should be trained of proper hygiene( handwashing and wearing gown, gloves, etc.) They should know that sterile preparations must have the highest level of quality and purity of all dosage forms. Should be trained in selecting and using different facilities and devices for compounding.
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Should learn methods in detecting viable microorganisms and how these samples should be gathered and incubated and signifying the results.

Aseptic Technique
Low-risk preparations:

-must be compounded in an ISO Class 5 air quality environment or better, from sterile ingredients, products, components, and devices. No more than three packages of sterile product can be used, and not 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 amiodarone 900 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 involved

Examples: a bag of parenteral nutrition; a norepinephrine (Levophed) 16 mg/250 mL infusion, where you 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.

What is garbing?

Garbing is the act of donning required PPE(Personal Protective

Equipment before compounding begins or before a worker enters a particular controlled pharmacy compounding space (such as a buffer area or the clean side of a compounding area).

IMPORTANCE:TO PREVENT THE SHEDDING OF VIABLE AND NON-VIABLE PARTICLES FROM THE BODY
OF A COMPOUNDING PERSONNEL. Humans are particle generators. Even though we cant see them, it is generally agreed that we shed about 9 pounds of dead skin cells from the stratum corneum (the outer layer of the skin) per year.

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)

 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 MUST BE PERFORM BEFORE ENTERING AND WHEN LEAVING THE BUFFER AREA!!!!!!

Packaging and Labeling:

Container needs to be sterile and it should maintain the sterility of 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.

PROPER LABELING
IDENTIFIES:
Medications,quantity,concentrations(doses) and expiration dates. Supplementary informations(how to prepare,CI,indications,proper storage,etc.) *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