Sterile compounding Flashcards
primary engineering control [PEC]
(Hoods, isolators) are called ventilation devices. the air provides sweeps particles.
+ pressure for non-hazardous (Protect the product) and - pressure for hazardous (protect the compounder)
Must be a minimum of ISO 5 (3,520)
Buffer Area
Area around the HOOD or PEC
Must be min ISO 7 (352,000)
Ante Area
Adjacent to the buffer area (hand washing and garb station)
ISO 7 if it opens to a negative pressure
ISO 8 if it opens into a positive pressure
PEC cleaning schedule
Must be cleaned: before each shift before and after drug a batch q 30 minutes and whenever after a spill
wipe with 70% IPA and sterile lint-free wipes
Laminar Airflow work bench
In a horizontal LAFW, nothing should be behind the sterile object
Verticle nothing should be on top of the sterile object
Biological Safety Cabinets
used for chemo and hazardous drugs Negative Pressures keeps air from the staff
Segregated Compounding Area
has unclassified air and compounds has a shorter BUD 12 h
Glove fingertip test
Evaluates garb and gloving technique
requires 3 consecutive samples to pass with zero CFUs. annually for low to med risk
semi annually for high risk
Media-fill test
evaluates aseptic techniques and must be turbid free after 14 days
frequency same as glove fingertip test
Cleaning and Disinfection
IPA 70% clean from cleanest to dirtiest.
PEC to buffer area, to ante area.
Bubble point test
forces bubble out of filter test
Sterility testing
Tryptic soy broth (TSB)
Fliud thiglycollate medium (FTM)
Bacterial endotoxin Pyrogen
Pyrogen bacteria removal
Rinse stuff with sterile water using dry-heat oven sterilization
LAL is the reagent for the endotoxin test
Environment monitoring
Temp: minimium daily
Air sampling: q 6 months
Surface sampling: periodically
Air pressure: q shift or daily minimum
Recalls
High RIsk CSP are dispesnsed before recieving results of the sterility testing and must be observed daily observation and immediate recall if bacteria growth is seen.
