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4 Cards in this Set
- Front
- Back
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Definitions |
Ante- space outside the sterile compounding area where hand washing and garbing is done. ISO 7 Buffer area- the cleanroom where compounding is done, ISO 7/8 Biological safety cabinet- the hood Positive pressure- keeps air from entering hood, for most sterile preparations Negative pressure- keeps air from leaving hood, gor hazardous drugs ISO class- particles in air, lower = less Primary engineering control- ISO 5 HEPA filter- removes 99.97% as small as 0.3 microns |
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Cleaning schedule |
Buffer- beginning of shift, before and after batches, after spills, every 30 min. Of continuous use, any contamination Counters, work suface and floors- daily Walls, ceiling, storage area- monthly |
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Garbing |
Dirtiest to cleanest: Hair/face-> shoes-> hand hygiene-> gown-> hand cleaning with alcohol-> sterile powder-free gloves |
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Recall |
Done by manufacturers, not FDA. FDA can make requests Class I- reasonable probability for serious adverse event or death Class II- temporary or reversible adverse event where harm is remote Class III- not likely to cause harm |
