Compounding

Question 1

Hazardous Compounding (C-PEC / C-SEC) Air Pressure?

Answer 1

Negative Air Pressure

Question 2

Hazardous Compounding (C-PEC / C-SEC) Air Changes Per Hour (ACPH)?

Answer 2

Non-sterile HD = 12 ACPH

Sterile HD = 30 ACPH

Question 3

Hazardous Compounding (C-PEC / C-SEC) External Exhaust; exception?

Answer 3

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)

Question 4

Hazardous Drugs

Answer 4

Chloramphenicol
Telavancin

Fluconazole / Voriconazole

Dronadarone

Paroxetine

Cholchicine

Methimazole / Propylthiouracil

Question 5

PEC?

Answer 5

Primary Engineering Control (PEC) = Sterile Hood

Question 6

Types of PEC / C-PEC?

Answer 6

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

Question 7

Compounded Sterile Products (IV bags) Small vs Large?

Answer 7

Small ≤ 100 mL

Large > 100 mL

Question 8

International Standards Organization (ISO) levels for each area? Air Pressure for Non-HD / HD?

Answer 8

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!

Question 9

Steps to prevent contamination when about to compound in PEC:

Answer 9

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

Question 10

Beyond-Use Date for CSPs made in an Isolator Hood at a SEGREGATED COMPOUNDING AREA:

Answer 10

12 hours

Question 11

Temperatures?

Answer 11

Once Daily = SEC ≤ 20C (68F)

Twice Daily = Refrigerator 2 to 8C / Freezer -50 to -15C

Question 12

Steps to clean PEC (Materials / Areas / Methods):

Answer 12

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

Question 13

Hazardous Drug Sanitization:

Answer 13

1) Deactivating / Decontaminating = 2% Bleach (Sodium Hypochlorite) or Peroxide
3) Clean = Germicidal Detergent (Quat, Ammonium, Phenolics)
4) Disinfect = 70% IPA

Question 14

Black / Yellow / Red Waste Bins:

Answer 14

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!)

Question 15

Eye drug exposure rinsing:

Answer 15

15 minutes

Question 16

Garbing for HD (Gloves / Gown):

Answer 16

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

Question 17

USP 795 / 797 / 800?

Answer 17

795 = Non-Sterile
797 = Sterile
800 = Hazardous Drugs

Question 18

BUD Non-sterile Compounds

Answer 18

Aqueous / Oral = 14 days, refrigerated
Aqueous / Topical = 30 days
Non-aqueous = 180 days

Question 19

BUD CSP Risk: LOW

Answer 19

Room Temp = 48 hr
Fridge = 14 days
Freezer = 45 days

Question 20

BUD CSP Risk:
Low Non-HD
Low/Med HD

Answer 20

Room Temp = 12 hr

Fridge = 12 hr

Question 21

BUD CSP Risk: MEDIUM

Answer 21

Room Temp = 30 hr
Fridge = 9 days
Freezer = 45 days

Question 22

BUD CSP Risk: HIGH

Answer 22

Room Temp = 24 hr
Fridge = 3 days
Freezer 45 days

Question 23

BUD CSP Risk: IMMEDIATE USE

Answer 23

Room Temp = 1 hr

Question 24

BUD Single-Dose Containers & Multi-Dose Containers:

Answer 24

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