Compounding Flashcards
If there are separate sterile and non-sterile C-PECs in the same C-SEC, how far must they be apart?
1 meter
What kind of pressure do C-PECs, C-SECs, and C-SCAs have to have?
negative pressure
In space where non-sterile HDs are compounded and in a C-SCA, how many air changes per hour (ACPH) should there be?
12
In a sterile C-SEC, how many ACPHs should there be?
30
Redundant HEPA filters can only be used in what type of compounding?
non-sterile HD compounding
How do HDs have to be stored?
stored separately from non-HDs in an externally ventilated, negative pressure room with at least 12 ACPH
What is the media-fill test used for?
sterile drug preparation
What is the gloved fingertip test used for?
hand hygiene, garbing, and gloving
How often do you have to pass a gloved fingertip test if compounding low and medium-risk CSPs?
What about high risk CSPs?
Annually
Semi-annually
How often does a media fill test need to be performed for low and medium risk CSPs?
annually
Tryptic soy broth (TSB) is used for what test?
media fill test
Tryptic soy agar (TSA) is used for what test?
gloved fingertip test and surface sampling
What temp should the fridge stay at?
2-8 C
What temp should the freezer be kept at?
between -25 and -10C
If a freezer contains vaccines, what temp should it be kept at?
between -50 to -15 C
How often should air sampling be done?
every 6 months
In surface sampling, action must be taken if CFUs are greater than what in ISO 5, ISO 7, and ISO 8 areas?
ISO 5: > 3 CFUs
ISO 7: > 5 CFUs
ISO 8: > 100 CFUs
How often should air pressure be checked?
Every work shift or once daily (minimally)
How often should humidity be checked?
daily
How long do you have to wait to start compounding in a PEC or C-PEC if the power was shut off?
30 minutes
What kind of wipes are used to clean a PEC?
lint-free sterile wipes
What is the order that PECs should be cleaned?
top to bottom, back to front
cleanest areas are cleaned first and dirtiest areas are cleaned last
ISO 5 PECs are cleaned how often (4)?
before each shift
every 30 minutes while working
before and after each batch of CSPs
whenever needed, including after spills
What items can be cleaned monthly in sterile compounding (6)?
ceiling, walls, shelves, chairs, bins, carts
What is the correct order of sanitization of HDs?
- Deactivation and decontamination
- Cleaning
- Disinfection
What’s used in deactivation and decontamination?
2% bleach (sodium hydrochlorite) or peroxide
reduces HD toxicity, then removes HD residues
deactivation and contamination
What’s used in cleaning?
germicidal detergent (quat, ammonium, phenolics)
removes dirt and microbial contamination
cleaning
What’s used in disinfection?
sterile 70% isopropyl alcohol