ISO Environments
This ISO class is required for the primary engineering control (PEC) like a laminar airflow workbench.
ISO Class 5
A sterile, needle-tipped device used to withdraw medications.
syringe
The first item to be put on for garbing.
shoe covers
Before use, the hood must run for this amount of time if turned off.
30 minutes
This chapter sets the standard for sterile compounding.
USP <797>
This area includes the buffer room, typically ISO Class 7.
clean room
This type of needle is used to draw medication from ampules.
filter needle
Hands must be washed for at least this long.
30 seconds
The cleaning direction in a laminar flow hood.
top to bottom, back to front
BUD stands for this
Beyond-Use Date
This pressure condition is used in the ante room when compounding nonhazardous sterile products.
positive pressure
This container holds sterile fluids and must be swabbed before puncture.
vial
This must be removed before beginning handwashing.
jewelry or watches
These should never be placed in the DCA.
paper or nonsterile items
A single-dose vial must be used within this time if opened in ISO 5.
6 hours
This area supports handwashing, garbing, and supply staging before entering the buffer room.
ante room
This glass container must be broken open to access medication.
ampule
This must be used to clean nails during handwashing.
nail pick or brush
This is the proper distance inside the hood where compounding should occur.
6 inches from the edge
USP <797> and <800> are both enforced by this regulatory agency.
FDA
What ISO class must an ante room maintain?
ISO Class 8
The beveled tip of this component must face up during insertion.
needle
Gloves must be disinfected with this before compounding.
70% isopropyl alcohol
PECs must be cleaned this often.
before each shift, every 30 minutes during use, and after spills
How long are MDV good for when punctured?
30 days