Commounding Basics Flashcards
Which USP Chapter is for Non-Sterile Compounding?
USP 795
Which USP Chapter is for Sterile Compounding?
USP 797
Which USP Chapter for Hazardous?
USP 800
What is the ISO rating for Anteroom if it opens into a negative pressure SEC?
ISO 7
What is the ISO rating for Anteroom if it opens into a positive pressure SEC?
ISO 8
What is the ISO rating for the Primary Engineering Control (PEC)?
ISO 5
this means there are 3,520 particles = cleanest air
0.5 microns
How often should the HEPA filter be recertified for sterile compounding space?
6-months or when PEC is moved
HEPA filter for 0.3 microns
Cleanroom suite requirements for sterile hoods
ISO 5 for inside the hoods
ISO 7 buffer room
What type of airpressure MUST be used for hazardous compounding?
Negative pressure
Laminar Airflow Workbench (LAFW)
Open front PEC where filtered air runs horizontally
Compounding Aseptic Workbench
Closed front PEC “glovebox” so air stays in the PEC
Segregated Compounding Area
used when cleanroom is not an option. Deisgnated area with “unclassified air” and NEEDS to have CAI (closed front PEC)
What is the MAX beyond use date for sterile products made in a SCA?
12 hour BUD
What hazardous drugs types are included on the NIOSH list?
Carcinogenic
Tertaofenic
Genotoxic
Toxic to organs at low doses
labeled by manufacturer as toxic
What are some examples of drugs on the NIOSH list?
Mifepristone
Chloramphenicol
Warfarin
Fluconazole
Abacavir, Entecavir, Zidovudine
Isotretinoin
Ganciclovir
Dronedarone
Paroxetine
Dexrazoxane
Exenatide, Liraglutide
AEDs
Clonazepam
Colchicine
Ivabradine, Spironolactone
Ribavirin
Androgens/Estrogens/Progesterones
Dutasteride, Finasteride
Mithimazole, Propylthiouracil
Deferiprone
Dihydroerotamine
Apomorphine, Rasagiline
Bosentan
Ziprasidone
Cyclosporine, Mycophenolate, Tacrolimus, Sirolimus
How often should staff do gloved fingertip test and media fill test?
Initially
Annually - medium risk CSP
Semiannually - high risk CSP
What are the pass results for gloved fingertip test?
3 consecutive samples with ZERO CFUs done after garbing
What are the pass results for media fill test?
The tryptic soy broth filled IV bags stay clear after 14 days of incubation
*testing aseptic technique
What is the temperature requirement for refrigerators and freezers?
2-8 degreesC for fridge
(-25) - (-10) degreesC for freezer
What is the humidity control requirement?
Checked at least daily
< 60%
What are the surface sampling requirements for different ISO areas?
ISO 5 < 3 CFUs
ISO 7 < 5 CFUs
ISO8 < 100 CFUs
Steps to clean the Horizontal Laminar Airflow PEC?
- Ceiling back to front
- Grill back to front
- Sides back to front
- Anything left in the hood
- Bottom surface back to front
What do you use for disinfection for sterile compounding?
70% Isopropul Alcohol
What do you use for deactivation and decontamination of hazardous work spaces?
2% bleach (sodium hypochlorite)
or peroxide
Where should you dispose of clearly visable hazardous material?
BLACK container
Where should you dispose of trace hazardous waste?
YELLOW cantainer
When administrating HD drugs what should you use?
-2 pairs of chemo gloves (ASTM D6978 rated)
-chemo gown
-fit-tested N95 mask
-head cover
-eye protection
-2 pairsshoe covers
-closed system drug transfer device
Garbing for Sterile Hazardous Drugs
- remove jewelry and makeup
- cover face and head
- place shoe covers on while stepping over the line of demarcation
- wash hands with soap and water
- put on non-shedding goqn
- put on gloves using sterile technique in the SEC
- sanitize gloves before entering into the PEC
