Compounding Flashcards
Hazardous Compounding (C-PEC / C-SEC) Air Pressure?
Negative Air Pressure
Hazardous Compounding (C-PEC / C-SEC) Air Changes Per Hour (ACPH)?
Non-sterile HD = 12 ACPH
Sterile HD = 30 ACPH
Hazardous Compounding (C-PEC / C-SEC) External Exhaust; exception?
STERILE HD = MUST have External Exhaust to remove HD-contaminated air from the room
NON-STERILE HD = can use REDUNDANT HEPA FILTER (Double-HEPA Filter)
Hazardous Drugs
Chloramphenicol
Telavancin
Fluconazole / Voriconazole
Dronadarone
Paroxetine
Cholchicine
Methimazole / Propylthiouracil
PEC?
Primary Engineering Control (PEC) = Sterile Hood
Types of PEC / C-PEC?
1) Laminar Airflow Workbench (Horizontal) = PEC / Non-HD
2) Biological Safety Cabinet (Vertical) = C-PEC / HD
3) Compounding Aseptic Isolator (CAI) = Non-HD / positive pressure
3) Compounding Aseptic Containment Isolator (CACI) = HD / negative pressure
Compounded Sterile Products (IV bags) Small vs Large?
Small ≤ 100 mL
Large > 100 mL
International Standards Organization (ISO) levels for each area? Air Pressure for Non-HD / HD?
PEC (non-HD / positive) = 5
SEC (non-HD / positive) = 7
Anteroom (non-HD / positive pressure) = 7/8
C-PEC (HD / negative pressure) = 5
C-SEC (HD / negative pressure) = 7
Anteroom (HD / negative pressure) = 7 ONLY!
Steps to prevent contamination when about to compound in PEC:
1) Wipe down all materials (vials, syringes, bags) with 70% isopropyl alcohol (IPA) before placing into PEC
2) Compound 6 INCHES inside the PEC
3) Remove waste from PEC as you are compounding
Beyond-Use Date for CSPs made in an Isolator Hood at a SEGREGATED COMPOUNDING AREA:
12 hours
Temperatures?
Once Daily = SEC ≤ 20C (68F)
Twice Daily = Refrigerator 2 to 8C / Freezer -50 to -15C
Steps to clean PEC (Materials / Areas / Methods):
Materials:
1) Lint-free sterile wipes
2) Germicidal Detergent FIRST
3) THEN, 70% IPA
4) Leave PEC running for 30 minutes
Areas:
1) Top -> Bottom
2) Back -> Front
Methods:
1) Do not spray IPA in hood
2) Unidirectional, slightly overlapping
Hazardous Drug Sanitization:
1) Deactivating / Decontaminating = 2% Bleach (Sodium Hypochlorite) or Peroxide
3) Clean = Germicidal Detergent (Quat, Ammonium, Phenolics)
4) Disinfect = 70% IPA
Black / Yellow / Red Waste Bins:
Black Waste Bin = Bulk HD (drug vials / IV bags with visible HD, materials used to clean HD spills)
Yellow Waste Bin = Trace HD (empty syringes / empty IV bags / empty vials, PPE)
Red WASTE BIN = Infectious Waste (IV tubing and used culture dishes)
Red SHARPS CONTAINER = Non-HD sharps (do NOT place HD syringes here, put them in Yellow Waste Bin!)
Eye drug exposure rinsing:
15 minutes
Garbing for HD (Gloves / Gown):
Gloves:
1) Changed every 30 mins
2) Sterile HD = TWO pairs ASTM / powder-free
3) Non-sterile HD = ONE pair
Gown:
1) Must CLOSE IN THE BACK
2) Change every 2-3 hours
USP 795 / 797 / 800?
795 = Non-Sterile 797 = Sterile 800 = Hazardous Drugs
BUD Non-sterile Compounds
Aqueous / Oral = 14 days, refrigerated
Aqueous / Topical = 30 days
Non-aqueous = 180 days
BUD CSP Risk: LOW
Room Temp = 48 hr
Fridge = 14 days
Freezer = 45 days
BUD CSP Risk:
Low Non-HD
Low/Med HD
Room Temp = 12 hr
Fridge = 12 hr
BUD CSP Risk: MEDIUM
Room Temp = 30 hr
Fridge = 9 days
Freezer = 45 days
BUD CSP Risk: HIGH
Room Temp = 24 hr
Fridge = 3 days
Freezer 45 days
BUD CSP Risk: IMMEDIATE USE
Room Temp = 1 hr
BUD Single-Dose Containers & Multi-Dose Containers:
SDC:
Outside ISO 5 = 1 hr from puncture / opening
Inside ISO 5 = 6 hr from puncture / opening
MDC:
Inside / Outside ISO 5 = 28 days from puncture / opening