USP Flashcards
USP 795, non-preserved, aqueous dosage form expiration date
14 days (FRIDGE ONLY!)
USP 795, preserved, aqueous dosage form expiration date
35 days (fridge, CRT)
USP 795, oral liquids, non-aqueous expiration date
90 days (CRT or fridge)
USP 795, other nonaqueous dosage forms expiration date
180 days (CRT or fridge)
Aqueous preparations, Aw>0.6
creams, suspensions, gels, emulsions, sprays
Nonaqueous preparations, Aw<0.6
ointments, capsules, tablets, granules, powders, nonaqeous suppositories, troches
USP 797, Category 1
compounded in the least controlled environmental conditions, and may be prepared in an unclassified segregated compounding area
USP 797, Category 2
Compounded in a clean room
USP 797 Category 3
Undergo sterility testing, must garb to prepare, environment must be tested
How often do media fill testing & glove sampling need to be done?
Semi-annually
How often does surface sampling in the compounding area need to be done?
Monthly
USP 797 Category 1 BUDs
<12 hours room temp, <24 hours fridge
USP 797 Category 2 BUDs if aseptically processed, no sterility testing, only sterile starting components
4 days at room temp
10 days in fridge
45 days in freezer
USP 797 Category 2 BUDs if aseptically processed, no sterility testing, one or more non-sterile starting components
-1 day at room temp
-4 days in fridge
-45 days in freezer
USP 797 Category 3 BUDs, aseptically processed, sterility tested, passing all applicable Category 3 tests
-60 days at room temp
-90 days fridge
-120 days freezer
USP 797 Category 3 BUDs, terminally sterilized, sterility tested, passing all applicable category 3 tests
-90 days room temp
-120 days fridge
-180 days freezer
Primary Engineering Control (THE HOOD!) air quality
ISO 5 (3520 particles/m2)
Buffer Area
Ante Area if it opens into a negative pressure rom (HD compounding)
ISO 7 (352,000 particles/m2)
Ante Area if t opens into a positive pressure room (sterile, non-HD compounding)
ISO 8 (3,520,000 particles/m2)
ISO Class 5 Primary Engineering Control (PEC)- how often to clean
-Beginning of each shift
-not longer than 30 minutes following previous surface disinfection when ongoing compounding activities are occurring
-After spills
-when surface contamination is known or suspected
Floors frequency of cleaning
Daily
Walls, windows, shelving, bins, chairs
Weekly
Ceiling
Monthly
Cleaning the PEC
-First cleaned with a germicidal detergent, then disinfected with 70% IPA
