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compounding sterile preparations |
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Definition
-mostly IV admixtures -prepared by pharmacy personnel -therapeutic drugs (SVPs) -maintenance fluids (LVPs)(IV admixtures) |
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-gauge (outer diameter, indirectly related) -16G to 32G -16 G used for compounding -length-3/8 to 1.5 in, coated with lubricant |
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-just to remove small glass particles -typically 5 micrometers -membrane = 0.2 micrometers -for sterile= .22 micrometers -used for one-time use only |
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-Luer-lok (fits needle) -slip |
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-3/10 ml to 60 ml -dont measure less than 20% max volume |
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-piston -read from leading edge |
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-any opening or surface which provides a pathway between sterile products to the environment -plunger, tip |
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sterile product manipulations: ampule |
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-tap, swab, snap -filter needle one way |
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sterile product manipulations: vials |
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-removes seal , swab stopper -solution product-inject air and withdraw solution -solid product-inject solution and withdraw air |
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sterile product manipulations: bags |
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-swab addivitive port -penetrate through both diaphragms |
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-incorrect strength -instability -incompatibility -contamination |
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USP 797 sterile preparations |
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-quality and control process, components, and environment -knowledge and skills of personnel -QA/QC systems |
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-procedures to minimize contamination (controlled environment) -aseptic skills -cleansing/garbing skills procedures -proper use of LAFWs -protect critical sites |
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-remove outer garments, cosmetics, and jewelry/piercings -no nails -shoes covers, hair covers, face masks -wash hands up to elbow for 30 seconds -put on long sleeve gown -prepare labels and gather supplies -enter buffer area or clean room -apply hand sanitizer -put on sterile gloves |
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-leave on for at least 30 min before use -clean and disinfect frequently -bring only necessary items into hood -minimize air turbulence (dont move too much) -do not block critical sites from clean air -change or disinfect gloves if hands move out of the hood |
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-for general purpose mixing of non hazardous products -all work done at least 6 inches inside the hood -no hands or products behind critical sites |
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-various designs -work behind the sash (no 6 in rule) -no hands or products above critical sites -biological safety cabinets (BSC)-contaminated air not released into the room, used for hazardous products, protect product and personnel |
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-cytotoxic agents, blood products, etc -use BSCs -extra personal protective equipment (PPE) - avoid positive pressure built up in containers |
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-no more than 3 additives |
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-non sterile raw material -exposure to non sterile environment -product examples? immediate use CSP, allows use of injectable in clinic |
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