Compounding I: Basics Flashcards
A series of safety documents required by the occupational safety and health administration to be accessible to all employees who are working with hazodous material
SDS “safety data sheets”
Where are powders made?
in a powder containment hood
“Ventilated compounding enclosure”
The sterile compounding space must include an”
anteroom
buffer area
primary engineering control or a segregated compounding area
Hoods and buffer rooms used for compounding HDs begin with the word
containment “C-PEC, C-SEC”
The C-sec must contain what type of ISO
ISO 7
There must be separate sterile and non-sterile C-PECs kept how far apart
1 meter
C-PECs and C-SECs must have what type of air pressure
negative
HD drugs must be stored separately from non-HD drugs in an externally ventilated ____ pressure room with at least ___ ACPH
negative, 12
Sterile HD ACPH=
30 ACPH
non-sterile HD ACPH=
12 ACPH
What is used when external venting is not reasonable
Redundant HEPA filters
*can only be used for non-sterile HD
The sterile hood, there are different types including conventional laminar airflow workbench and a compounding aseptic isolater
primary engineering control (PEC)
The buffer room or sterile compounding room
SEC
The isolator
compounding aseptic isolator
This is the chemo hood for sterile chemo drugs and other sterile HDs. this is a containment PEC or C-PEC
Class II biological safety cabinet (BSC)
The isolator glove box for HDs
compounding aseptic containment isolator
The room where the C-PEC Is located is called
the containment secondary engineering control or C-SEC
If the hood is not in a C-SEC, then it has to be in a compounding aseptic containment isolator
IV container up to 100mL
small parenteral
> 100mL is large
In critical areas that are closest to exposed sterile drugs and containers (inside the sterile hood, PEC) the air must be at least ISO__
5
0.5m
ISO rating: PEC
5
3520 particles
ISO rating: SEC/buffer room
ISO 7
352000
ISO rating for anteroom if it opens into a negative pressure SEC
7
same ISO # as the SEC
Ante room if it opens into a positive pressure SEC
8
Biological Safety Cabinet (BSC) =
the C-PEC
Laminar airflow workbench =
PEC
What is first air?
air from the HEPA filter
checked every 6 months
What is the line that separates a room clean and dirty sections
line of demarcation
hazardous and non hazardous drugs must be down in what type of air pressure room
negative
for others it doesn’t matter
What is the compounding aseptic isolators?
this is what we used when our clean room was messed up and still have to make the TPNs and it was located in a segregated compounding area (SCA)
for HD = “CACI”
The maximum BUD for CSPs made in an isolator in an SCA or C-SCA is
12 hours
in a positive pressure area the ISO must be
8
in a negative pressure area the ISO must be
7
What is the color of the waste bucket for non hazardous
red
sharps and non HD waste
color of the waste bucket for hazardous
yellow
trace HD waste - vials and syringes
for the finger print test, what is the finger print test use to plate it
tryptic soy agar (TSA)
CFU = contaminated passing = 3 consecutive passes
what does the media fill use to see if there is bacteria
tryptic soy broth
pass = clean for 14 days
how often should the temp be monitored
once daily in the SEC
should be 68 or cooler
fridge (2-8C) and freezer (-50–15) monitored how often
daily
vaccines = twice daily
air sampling should be performed
every 6 months
surface sampling that’s tested with TSA(+polysorbate 80 and lecithin) are added to the TSA to neutralize the effect of any disinfecting agents on the surfaces
periodically
> 3CFU in the ISO 5 area
5CFU in the iso 7 area
100 CFU in the iso 8 area
= TAKE ACTION
air pressure testing every
once daily or every work shift
What is cleaned every day?
counters
floors
carts
cleaned weekly?
walls windows shelving bins chairs
Monthly cleaning?
ceiling
What are the steps to cleaning
deactivation and decontamination
cleaning
disinfection
What is used for the deactivation and decontamination?
2% bleach (sodium hypochlorite) or peroxide
What is used for cleaning?
germicidal detergent: Quat, ammonium, phenolics
what is used for disinfection?
70% IPA
What is the product that combines the deactivation and decontamination step?
period RTU or bleach
What is the complexity of this CSP?
requires compounding a preparation that has NO established stability data or a preparation with specialized calculations or procedures
mixing two topical ingrediatins without stability data for either
moderate
vs. simple and complex
How is hazardous waste disposed
put into a trash waste bad and sealed. this is BULK hazardous waste which is discarded in the black bulk hazardous waste bin
how many gloves should be worn when administering HDs
two
And a gown is required when administering IV HD, but recommended for oral HD
what must be used for nurses for drug administration for IV HD
closed system drug transfer devices (CSTDs)
recommended when compounding
bulk antineoplastic waste goes where?
BLACK container
Single gloves with HD can be worn when
receiving and storage
double for compounding or cleaning
If a BSC or CACI is not available then PPE should be used that includes
double gloves
a gown
mask
disposable pad to protect work surface
PPE for sterile HD compounding includes
head cover face mask cover beard cover two pairs of shoes a gown impeccable to lquids two pairs of ASTM D6978 rated gloves full face piece respirator or a face shield with goggles
