Term
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Definition
| Where hand hygiene, garbing, staging of necessary products and labeling should occur. Premitted to be ISO class 8 or better. |
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Term
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Definition
| Where the primary control (laminar/horizontal flow hood or isolate) is located. Staging of products may also occur here. This area should be ISO class 7 or better. |
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Term
| Low Risk Level Sterile Preparation |
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Definition
Single transfer from a sterile ampule utilizing sterile supplies.
Measuring or mixing manually two manufactured products to prepare an admixture.
Measuring or mixing manually three manufactured products to prepare a nutritional preparation. |
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Term
| High Risk Level Sterile Preparation |
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Definition
Sterile ingredients are measured and mixed in non sterile devices before sterilization is performed.
Dissolving non sterile bulk drug and nutrient powders to make solutions which will be terminally sterilized. |
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Term
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Definition
| Only a sterile transfer from a sterile vial utilizing sterile supplies. |
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Term
| Medium Risk Level Products |
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Definition
Using multiple ampules to be transferred into one final sterile container.
Compounded under low risk conditions but involve more than 3 sterile products or entries or complex procedures. |
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Term
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Definition
| Sterile ingredients measured/mixed with non sterile devices before sterilization is performed. |
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Term
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Definition
| For emergency or immediate patient care, products may be compounded in worse than ISO class 5 conditions if it will be administered within 1 hour, involves no more than 3 products/entries, and does not contain any hazardous drugs. |
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Term
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Definition
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Term
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Definition
| Head and/or facial hair covers |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Non shedding, disposable gown just prior to entering clean area |
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Term
| Garbing Step 6: Inside the Clean Area... |
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Definition
| hands should be sanitized with an alcohol-based surgical hand scrub with persistent activity. |
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Term
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Definition
| Sterile, powder free gloves should be donned before compounding begins. |
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Term
| Before and during compounding... |
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Definition
| gloves shall be sterilized with 70% isopropyl alcohol and inspected for holes/tears. |
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Term
| USP/NF 797 requires that air sampling for high risk level area be performed |
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Definition
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Term
| Work surfaces in the ISO class 7 and 8 area buffer/clean rooms should be |
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Definition
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Term
| Non shedding materials must be |
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Definition
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Term
| Equipment used for cleaning the sterile compounding areas should not be... |
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Definition
| used for cleaning non-sterile areas of the facility. |
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Term
| It is best to use ______ products when possible. |
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Definition
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