Compounding Flashcards
primary engineering control
(sterile hood/isolator)
ISO class 5
Secondary engineering control
(buffer room, anteroom if it opens a negative pressure buffer room, clean room)
ISO class 7
Anteroom (if opens into a positive pressure)
ISO class 8
HEPA filter
> 99.97% efficient in removing particles as small as 0.3 mircons
-needs to be recertified every 6 months
gloved fingertip test
initially and annually
media filled test
initially and annually
Temperatures
-checked daily
-maintained at 68F (20C)
air sampling
every 6 months
->3 CFU in ISO 5
->5 CFU in ISO 7
->100 CFU in ISO 8
air pressure testing
daily
deactivation and decontamination
2% bleach (Sodium Hypochloride) or peroxide
Cleaning
germicidal detergent
disinfection
sterile 70% isopropyl alcohol
non-aqueous formulations
no later than 6 months (180 days) at room temp
water-containing oral formulations
no later than 14 days when stored at controlled cold temperatures. Store in refrigerator
water-containing topical/dermal and mucosal liquid and semisolid formulations
no later than 30 days at room temp
CSP risk level: low
Room temp BUD: 48 hrs
Refrig temp BUD: 14 days
Frozen: 45 days
CSP risk: medium
Room temp BUD: 30 hrs
Refrig temp BUD: 9 days
Frozen: 45 days
CSP risk: high
Room temp BUD: 24 hrs
Refrig temp BUD: 3 days
Frozen: 45 days
CSP risk: low and not in clean room
Room temp BUD: 12 hr
Refrig temp BUD: 12 hr
immediate use
room temp BUD: 1 hr
CSP low risk
< 3 ingredients (including diluent)
no more than 2 entries into 1 sterile container or device
CSP medium risk
> 3 sterile ingredients OR
multiple doses of a sterile product w/drawn from the same vial to make several CSP of the same product
CSP high risk
SDC - outside an ISO 5 environment
1 hr from the time of puncture or opening
SDC - inside an ISO 5 environment
up to 6 hrs from the time of puncture or opening
SDC - ampule inside or outside ISO 5 environment
discard
MDC - inside or outside ISO 5 environment
up to 28 days
