Sterile Compounding (ampoule, vile, chemo) Flashcards
All dosage forms administered by ________ routes must be sterile.
Parenteral
Pyrogens can’t form under what 2 conditions?
- manufactured w sterile components
2. under aseptic conditions
Ante room is ______ pressure
positive
What’s the line of demarcation
line in ante room that separates dirty and clean side
ACHP of ISO 7?
> = 30
What is USP <797>?
General sterile compounding, minimum standards to be followed
What is USP <795>?
non-sterile compounding
What is USP <800>?
hazardous drug compounding
What 3 things don’t need to follow <797>?
- non-hazardous compounded sterile preparation used w/in 1 hour
- proprietary bag and vial system
- Allergenic extracts (used to diagnose allergic diseases)
How many Colony Forming Units are allowed after garbing and after compounding?
0 and 3
Ante-room with access to a positive pressure room = ISO ___ ?
ISO 8
CSPs must be prepared in ISO Class ___ ?
ISO 5
Negative pressure is when airflow is _______ hood/room and vented to the outside.
out of the hood/room
When to clean Primary engineering control?
beginning and end of each shift, after spills, when contamination is suspected
What should be cleaned daily? A. Counters B. Walls C. Doors D. Ceiling E. Work surfaces F. Floors G. Shelves
A, E, F
HEPA facts (%, size, direction, run for how long)
Removes 99.7% of all air particles as small as 0.3 microns. Flows in one direction, constant rate away from CSPs. Nothing should come in contact with HEPA filter. Run 30 mins to re-establish airflow if turned off.
What is an SCA?
Segregated Compounding Area. It’s when the PEC isn’t in a clean/buffer room so you designate an area for the CSPs to take place.
What’s IVLFZ?
Integrated vertical laminar flow zones
the HEPA filter comes from ceiling, entire room, open architecture
What is CACI? What kind of pressure?
Compounding aseptic containment isolators, neg pressure, hazardous drugs, type of RABS
SVP/LVP transfter
When you’re adding >10% of the total volume in bag, you should…?
remove equal amount from the bag prior to adding drug
T/F You should squeeze hard on IV bags with ports facing down to check for leaks
T
What belongs in pharmaceutical waste (black bin)?
UNBROKEN glass w >3% drug remaining
Pure drug powder
NO NEEDLES OR BROKEN GLASS
NO Plain fluid (normal saline, D5W, SWFI), Electrolytes, Parenteral nutrition ingredients (amino acids, dextrose, fats) CUZ THESE GO IN REGULAR TRASH
What is the anticoring technique used for?
Penetrating rubber stopper of vial w needle. 45 degree and then 90
Standard needle?
1 ½” 19 gauge hypodermic needle
Unit for specific gravity
g/ml
For emulsions you should use _________ mortar and pestle.
Wedgewood or ceramic. Not glass bc shear is hard to achieve. Glass mortar/pestle not very efficient in reducing particle sizes.
