BUDs Only Flashcards
(18 cards)
Nonpreserved aqueous dosage forms?
14 days refrigerated
Preserved aqueous dosage forms?
35 days refrigerated or room temp
Oral nonaqueous solutions?
90 days refrigerated or room temperature
Non-oral nonaqueous dosage forms?
180 days refrigerated or room temp
Nonsterile/USP 795 competency conducted every ___ months?
12 months
Category 1 or 2 garbing should be tested every ___. Air quality should be tested every ___ and surfaces should be tested every ___.
Category 1 + 2:
Garbing = every 6 months
Air quality = every 6 months
Surface testing = every month
Category 3 garbing should be tested every ___. Air quality should be tested every ___ and surfaces should be tested every ___.
Category 3:
Garbing = every 3 months
Air quality = every month
Surfaces = every week
Designated persons AND compounding overseers should have garbing/media fill tested every ____.
Every 12 months
Category 1 CSP at room temperature?
≤ 12 hrs
Category 1 CSP refrigerated?
≤ 24 hrs
Aseptically processed, no sterility testing with non-sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 1 day
Fridge = 4 days
Freezer = 45 days
Aseptically processed, no sterility testing with only sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 4 days
Fridge = 10 days
Freezer = 45 days
Aseptically processed, with sterility testing with only sterile ingredients? (Room temp, Fridge, Freezer)
Room temp = 30 days
Fridge = 45 days
Freezer = 60 days
Terminally sterilized Category 2, no sterility testing? (Room temp, Fridge, Freezer)
Room temp = 14 days
Fridge = 28 days
Freezer = 45 days
Terminally sterilized Category 2, with sterility testing? (Room temp, Fridge, Freezer)
Room temp = 45 days
Fridge = 60 days
Freezer = 90 days
Category 3 aseptic (room temp, fridge, freezer)?
Room temp = 60 days
Fridge = 90 days
Freezer = 120 days
Category 3 terminally sterilized (room temp, fridge, freezer)?
Room temp = 90 days
Fridge = 120 days
Freezer = 180 days
How often should HD competency be tested?
Every 12 months
