sterile and hazardous compounding

What is ISO?

International Standards Organization

- Sets the standards for air quality

The ______ the particle count, the cleaner the air

A. Higher

B. Lower

B. Lower

In critical areas that are closest to the exposed sterile drugs, the air quality must be at least ISO ___. **

5

PEC meaning *

• Primary engineering control

• the actual IV hood where you compound your sterile products!!

• Sometimes called a laminar airflow workbench

SEC Meaning *

• Secondary engineering control

• The buffer room that houses the PEC!

- Usually referred to as the sterile compounding room

Anteroom meaning *

Room connecting the SEC to the outside world and where garbing & handwashing occur

The SEC (the actual IV clean room, not the hood) must be at least ISO ___. *

7

The anteroom (handwashing & garbing) must be at least ISO ___. **

8

The PEC (IV clean room hood), must be at least ISO ___.

5

Non-hazardous PEC and SEC air **

A. Positive air pressure

B. Negative air pressure

A. Positive air pressure

helps prevent contamination when doors open - pushes particles out

Hazardous PEC and SEC air **

A. Positive air pressure

B. Negative air pressure

B. Negative air pressure

Dont push out chemo particles this would be harmful

Buffer room (IV room)

A. Positive air pressure

B. Negative air pressure

B. Negative air pressure

keeps particles inside

Laminar flow hood is _____

A. unidirectional

B. bidirectional

A. unidirectional

HEPA filter. must be recertified by a specialist every ___ months

6

LAFW meaning *

• Laminar airflow workench

• Type of PEC where air flows in unidirectional lines from back of the hood

• AKA: horizontal laminar airflow

CAI meaning

• Compounding aseptic isolater

• GLOVE BOX

• Non-hazardous, ISO 5

BSC Meaning

• Biological Safety Cabinet

• "Chemo hood"

• Used in negative pressure SEC room

Fingertip & media fill to know **

• Fingertip & media testing every 6 months

• For initial test need at least 3 consecutive samples from both hands, with no more than 3 CFU's for both hands

• Medial fill pass if clear liquid after 14 days of incubation

Types of sampling to know **

• AIR SAMPLES: every 6 months

• SURFACE: every 30 days

• WIPE SAMPLES: every 6 months for hazardous drug residue

How often should the PEC be cleaned? and with what products?

Once daily --> Cleaning agent (Preempt), then disinfecting (sterile 70% ISP)

Once monthly --> Sporicidal (Predex)

Sterile ___% IPA (isopropyl alcohol) should be used to wipe off everything in the clean room

70

All work within the PEC must be performed at least __ inches from the front

6

What is the BUD for immediate use compounded sterile products if kept at room temp, refrigerated, or frozen?

4 hours

What is the BUD for Category 1 compounded sterile products if kept at room temp, refrigerated, or frozen?

12 hours room temp

24 hours if refrigerated

N/A if frozen

What is the BUD for Category 2 compounded sterile products if kept at room temp, refrigerated, or frozen?

1-45 days if at room temp

4-60 days if refrigerated

45-90 days if frozen

What is the BUD for Category 3 compounded sterile products if kept at room temp, refrigerated, or frozen?

60-90 days if at room temp

90-120 days if refrigerated

120-180 days if frozen

T/F: BUD takes into account sterility only

False - it takes into account sterility & stability

Single dose vs multi dose containers BUD

• Single dose is up to 12 hrs from puncture or opening

• Multi dose is up to 28 days (think insulin)

NIOSH abbreviation

National institute for occupational safety and health

list of hazardous drugs

A drug is considered hazardous if it is: (5) **

• Carcinogenic

• Reproductive toxicity

• Organ toxicity at low doses

• Genotoxicity (cancer causing)

• Teratogenic

CROGT

SDS abbreviation

• Safety Data Sheets

• Required by OSHA

• Drug specific document that provides safety procedures and detailed instructions on managing exposures to hazardous materials

T/F: hazardous isolators must have an external vent

True - so the fumes/particles go out the building

Hazardous drugs. must be stored in a ____ pressure room with at least ___ ACPH. **

negative, 12

What extra do you need when garbing into hazardous room? (5)

• 2nd layer of shoe covers

• N95 mask

• Googles (only if splash hazard)

• 2nd disposable gown

• 2nd layer of gloves (ASTM standard D6978)

What color bin should all chemo garbing be placed in when done?

yellow bin

YELLOW CONTAINER BIN

• Trace hazardous waste

• Empty syringes, empty IV bags

• PPE

BLACK CONTAINER BIN

• Bulk hazardous waste

• Partially empty IV bags, syringes, vials

Hazardous drug cleaning steps (4) **

• Deactivation

• Decontamination

• Cleaning

• Disinfection (70% isoprop)

Which method of sterilization is preferred for heat labile CSP?

A. Dry heat sterilization

B. Gas sterilization

C. Filtration

D. Ionizing radiation

C. Filtration

What test confirms the integrity of a filter that will be used for terminal sterilization?

A. Glove hands test

B. TSB test

C. FTM test

D. Bubble point test

D. Bubble point test

Uses pressure to force water through the filter to determine the size of the largest pores (uword Q)

What gloves are required for preparing non-haz compounds?

1 pair of sterile powder free gloves

What should be worn when cleaning underneath the work surface of a C-PEC (hazardous)

A. N95 mask

B. Surgical face mask

C. Powdered air-purifying respirator

C. Powdered air-purifying respirator (PARP)

uworld

Separate sterile and non-sterile C-PECs in the same C-SEC must be kept ___ meter apart

1

For hazardous C-SEC's there must be ACPH of ≥___ for nonsterile and ≥___ for sterile

12, 30

How often must chemo gloves be changed when compounding?

every 30 minutes

How often must chemo gowns be changed?

every 3 hours

What is commonly used to decontaminate surface areas that have been exposed to hazardous drugs (like a chemo spill on the floor)?

Sodium hypochlorite (bleach)

What should be worn when unpacking hazardous drugs that are not wrapped in plastic?

Elastometric half-mask with multi-gas catridge and P100 filter

Which of the following is required to pass the initial gloved fingertip test?

A. At least one sample from both hands, with zero CFUs for both hands

B. At least one sample from both hands, with no more than 3 CFUs total for both hands

C. At least three consecutive samples from both hands, with zero CFUs for both hands

D. At least three consecutive samples from both hands, with no more than 3 CFUs for both hands

E. At least three consecutive samples from both hands, with no more than 5 CFUs total for both

D. At least three consecutive samples from both hands, with no more than 3 CFUs for both hands

Which of the following preparations require sterile compounding? (SATA)

A. Parenteral nutrition

B. Bladder irrigations

C. Pulmonary inhalations

D. Suppositories

E. Eye drops

A, B, C, E

The pharmacy receives a prescription for Gleevec 600 mg PO once daily. Which of the following statements is true regarding counting the Gleevec tablets?

A. Counting the Gleevec tablets must be done in a negative

pressure room.

B. The equipment used to count Gleevec tablets should be sanitized after use.

C. Counting the Gleevec tablets must be done in a biological safety cabinet.

D. Gleevec can be counted in an automated pill counter if the pill counter is used for HDs only.

E. Personal protective equipment should include a face shield when counting the

B. The equipment used to count Gleevec tablets should be sanitized after use.

A powder containment hood that has HEPA filtered air, negative air pressure and an exhaust system is called a:

A. Compounding aseptic isolator

B. Buffered compounding box

C. Secondary engineering control

D. Laminar airflow workbench

E. Containment ventilated enclosure

E. Containment ventilated enclosure

Which of the following is correct regarding bacterial endotoxins?

A. Endotoxins are only produced by Gram-negative bacteria.

B. Wash glassware used for compounding with tap water to decrease pyrogens.

C. Endotoxins from Gram-negative bacteria are the most potent.

D. The reagent used to test for endotoxins is TSB.

E. CSPs should be sterilized using filtration to avoid endotoxin

C. Endotoxins from Gram-negative bacteria are the most potent.xx

Which of the following drugs would be eligible for an Assessment of Risk?

A. Methotrexate tablets that are split in half

B. Hydroxyurea powder used to prepare an oral solution

C. Carboplatin intravenous solution that is added to a bag of normal saline

D. Intact tamoxifen tablets which are packed into unit-dose packages

E. Carmustine powder which is reconstituted with dehydrated alcohol

D. Intact tamoxifen tablets which are packed into unit-dose packages

What is AoR?

• Assessment of Risk

• Only for activities that do not require manipulation (like IV injection) but things like counting and packaging.

Garb for administration of HD (nurses)

• Antineopalstics: 2 pairs of chemo gloves

• Injectiable HD: chemo gown

• Risk of spill/splace: face & eye protection

Garb for receiving storage & transport of HD

single pair of chemo gloves

Which of the following compounded preparations can be safely sterilized using an autoclave?

A. Gentamicin

B. Protamine zinc insulin

C. Insulin glargine

D. Human chorionic gonadotropin injection

E. Levothyroxine

A. Gentamicin

How often should the laminar airflow workbench be cleaned? (4)

• Beginning of each shift

• Before & after each batch of CSP's

• Every 30 min while working

• After spills or suspected contaimination