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Pharmaceutics
Parenterals IV
24
Biology
Graduate
03/29/2012

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Term
compounding sterile preparations
Definition
-mostly IV admixtures
-prepared by pharmacy personnel
-therapeutic drugs (SVPs)
-maintenance fluids (LVPs)(IV admixtures)
Term
hub
Definition
-non-tip end
Term
shaft
Definition
-gauge (outer diameter, indirectly related)
-16G to 32G
-16 G used for compounding
-length-3/8 to 1.5 in, coated with lubricant
Term
bevel
Definition
-heel
-tip
Term
filter needle
Definition
-just to remove small glass particles
-typically 5 micrometers
-membrane = 0.2 micrometers
-for sterile= .22 micrometers
-used for one-time use only
Term
syringe tip
Definition
-Luer-lok (fits needle)
-slip
Term
syringe barrel
Definition
-3/10 ml to 60 ml
-dont measure less than 20% max volume
Term
syringe plunger
Definition
-piston
-read from leading edge
Term
oral syringe
Definition
not individually wrapped
Term
critical sites
Definition
-any opening or surface which provides a pathway between sterile products to the environment
-plunger, tip
Term
sterile product manipulations: ampule
Definition
-tap, swab, snap
-filter needle one way
Term
sterile product manipulations: vials
Definition
-removes seal , swab stopper
-solution product-inject air and withdraw solution
-solid product-inject solution and withdraw air
Term
sterile product manipulations: bags
Definition
-swab addivitive port
-penetrate through both diaphragms
Term
alarming error rates
Definition
-incorrect strength
-instability
-incompatibility
-contamination
Term
USP 797 sterile preparations
Definition
-quality and control process, components, and environment
-knowledge and skills of personnel
-QA/QC systems
Term
aseptic process
Definition
-procedures to minimize contamination (controlled environment)
-aseptic skills
-cleansing/garbing skills procedures
-proper use of LAFWs
-protect critical sites
Term
cleansing and garbing
Definition
-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
Term
LAFWs
Definition
-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
Term
horizaontal LAFWs
Definition
-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
Term
vertical LAFWs
Definition
-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
Term
hazardous products
Definition
-cytotoxic agents, blood products, etc
-use BSCs
-extra personal protective equipment (PPE)
- avoid positive pressure built up in containers
Term
USP 797 low risk
Definition
-no more than 3 additives
Term
USP 797 medium risk
Definition
-multiple additives
Term
USP 797 high risk
Definition
-non sterile raw material
-exposure to non sterile environment
-product examples? immediate use CSP, allows use of injectable in clinic
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