Chapter 15. Compounding I: Basics

USP 795

USP 797

USP 800

USP 795 NON STERILE COMPOUNDING

USP 797 STERILE COMPOUNDING

USP 800 HAZARDOUS COMPOUNDING

Hospital pharmacists use what for guidance on implementing USP standards?

ASHP (American Society of Health-System Pharmacists)

What is non-sterile compounding primarily used for?

Preparing a dose or formulation that is not commercially available

Avoid an excipient

Add a flavor

The buffer area (SEC; which contains the PEC) must be at least what ISO?

ISO 7

The further away from the PEC, the dirtier the air

The anteroom (room adjacent to the SEC where hand washing and garbing occurs) must be at least what ISO?

ISO 8 if it opens into a positive pressure buffer area (non-HD sterile compounding)

ISO 7 if it opens into a negative pressure buffer area (HD sterile compounding)

HEPA filters removes particles as small as how many microns?

0.3 MICRONS

Where is the HEPA filter in a vertical biological safety cabinet (BSC or C-PEC)?

At the top of the sterile hood

Where should compounding be done?

In the cleanest air (air coming directly out of the HEPA filter) called the direct compounding area (DCA) also known as the first air

How often should a HEPA filter be recertified?

Every 6 months and anytime a PEC has been removed

How far should compounding occur from the HEPA filter?

6 INCHES

What should the air pressure be in non-hazardous compounding?

PEC and SEC should both be POSITIVE since the air will not cause toxicity if it moves into adjacent spaces

Helps protect compounded sterile products (CSPs) from contamination

(ISO 8)

What should the air pressure be in hazardous compounding?

PEC and SEC should both be NEGATIVE pressure to contain and exhaust the toxic air in the space

Protects the compounding staff

(ISO 7)

What is a cleanroom suite?

Contains one or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom

Describe a laminar airflow workbench (LAFW)

Air flows out parallel from the HEPA filter (located at the back of the sterile hood)

Keeps the cleaner air from mixing with the dirtier air in the buffer room and keeps particles from colliding with each other and landing on the DCA surface or CSPs

A segregated compounding area (SCA) can be installed when a cleanroom is not able to be installed with what ISO classification?

Unclassified air

Safety Data Sheets (SDS) is required by what organization?

OSHA

What does the SDS contain?

Personal protective equipment (PPE)
First aid procedures
Spill clean-up procedures

How often are SOPs (standard operating procedures) reviewed?

Every 12 months or whenever a new drug or dosage form is stocked or used

As part of an assessment of risk (AoR), SOPs must be developed to include actions to limit staff exposure such as...

Putting HDs in distinctive shelf bins to alert staff
Weaking ASTM D6978-rated gloves when counting or packaging drugs
Dedicating a counting tray and spatula for counting HDs and decontaminating both after use
Placing prepared HD containers into a sealable plastic bag

Which of the following describes a biological safety cabinet (BSC)? (SATA)

a. Horizontal air flow
b. Vertical laminar air flow
c. Negative air pressure
d. Positive air pressure

b. Vertical laminar airflow
c. Negative air pressure

What are containment ventilated enclosures (CVEs)?

What are containment ventilated enclosures (CVEs)?

Powder containment hoods with HEPA filtered air and negative air pressure used for non-sterile compounding

What are compounding aseptic containment isolators (CACIs)?

Closed-front C-PECs (gloveboxes) that can be located in a buffer room (SEC) but often located in a C-SCA

What does negative air pressure do in C-PECs?

Causes the air flow into the C-PEC (away from the person who is standing at the front of the hood) and then to flow out of the C-PEC through the external exhaust at the top of the hood

What does negative air pressure do in C-SECs?

Keeps air from flowing into the anteroom. It is removed through the room exhaust

How often should the refrigerator and freezer temperatures be monitored?

Daily

Twice daily if they contain vaccines

What temperature should refrigerators be maintained at?

2-8

What should freezer temperatures be if they only contain CSPS and no vaccines?

-25 to -10 C

What should freezer temperatures be if they contain CSPS and vaccines?

-50 to -15 C

How often is air sampling for contaminants performed?

Every 6 months

How often is the inside of the PEC sampled?

END OF DAY

True or False: Pneumatic tubes can not be used to transport any liquid HDs or any chemotherapy drugs because of the potential for breakage and contamination

true

True or False: Non sterile compounding can be performed in ambient air (room air), but must be separated from the dispensing part of the pharmacy.

true

Two types of water:

Potable - (drinkable such as from the tap), for hand and equipment washing

Purified - (e.g., distilled) for use in water containing formulations and for rinsing equipment and utensils

Which of the following preparations require sterile compounding?

Eye drops (e.g., moxifloxacin and prednisolone eye drops)

Irrigations (liquid "washes" that go into a body cavity, such as gentamicin bladder irrigation)

Intravenous (e.g., 1 gram of vancomycin taken from a vial and injected into a 250 mL D5W IV bag)

Intramuscular and Subcutaneous drugs

Radiopharmeceutial (nuclear medicine drugs)

Pulmonary Inhalations (does not include nasal inhalations)

What ISO air rating is required for a compounding aseptic isolator?

5

ISO 5 compounding area:

Primary engineering Control (PEC, called the sterile hood, or isolator, if using a glove box)

ISO 7 compounding area:

Secondary engineering control (SEC, called the buffer room or buffer area)

Anteroom, if it opens into a negative pressure SEC (same ISO # as the SEC)

ISO 8 compounding area:

ISO 8 compounding area:

Anteroom, if it opens into a positive pressure SEC

What is the minimum ISO requirement for an anteroom that is attach to a positive pressure buffer room?

ISO 8

True or False: In a vertical airflow biological safety cabinet or C-PEC the HEPA filter is at the top of the sterile hood. In a laminar airflow workbench or PEC the HEPA filter is at the back of the sterile good (horizontal airflow)

True

Prevent contamination by keeping the air in the PEC clean:

Wipe off the outside of all material (e.g., vials, syringes) with 70% isopropyl alcohol before bringing them into the PEC

Open package along the designed tear line if present; do not rip open packages or punch needles or syringes through the wrappers with contaminates the air with particles

Compound at least 6 inches inside the sterile hood to prevent exposing CSPs at dirtier ISO 7 air from the SEC

Move waste out of the PEC shortly after it is created; do not let it accumulate inside the sterile hood

True or False: For non-hazardous compounding the air pressure include the PEC and SEC are both positive since the air will not cause toxicity if it moves into adjacent spaces

true

True or False: For hazardous compounding, the containment PEC (C-PEC) and the containment SEC (C-SEC) must have negative pressure to contain and exhaust the toxic air in the space

true

Which of the following are primary engineering controls designed for preparing non hazardous compounded sterile products?

Compounding aseptic isolator - is a closed front PEC that can be located in a buffer room but is often located in a segregated compounding area

Laminar airflow workbench - is an open front PEC where air flow out in parallel lines form the HEPA filter, typically from the back of the hopped i.e., horizontal laminar airflow

Another name for the buffer room is:

Secondary engineering control

True or False: The anteroom contains a sink, cabinets and benches to facilitate garbing and preparation for compounding. Shoe covers must be applied one at a time while stepping over the demarcation line, placing the covered shoe on the clean side

true

True or False: A segregated compounding area is designate area in the pharmacy, such as a corner in the regular pharmacy space, where an isolator is located. The air in the SCA is unclassified with no minimum ISO air requirements

true

If a compounded sterile product us prepared in a compounding aseptic isolator that is located in a segregated compounding area, what is the maximum beyond use date that can be assigned?

12 hours

Which if the following outcomes from a drug exposure would indicate that the drug is hazardous?

Carcinogenic (cancer causing)

Teratogenic (causes congenital disabilities) or reproductive toxicity (e.g., infertility)

Genotoxic (damage DNA, which can cause cancer)

Toxic to organs at low doses

Labeled by the manufacturer with special handling instructions

A bag of ganciclovir began leaking while the nurse was hooking it up to the patient's IV. The drug soaked through the cuff of the nurse's gown and made a puddle on the floor. Which of the following should be consulted for recommendation on personal protective equipment, first aid procedures and spill clean up?

The Safety Data Sheet

True or False: Assessment of Risk documents must be reviewed at least every 12 months and the review must be documented

true

Hoods and buffer rooms used for compounding HDs include the word containment:

Containment-primary engineering control (C-PEC)

Containment-secondary engineering control (C-SEC)

Containment-segregated compounding area (C-SCA)

Containment aseptic containment isolator (CACI)

True or False: Biological safety cabinets have vertical laminar airflow (air flow down from the HEPA filter at the top of the hood) and negative air pressure, which protects the worker from being exposed to the hazardous drug they are working with.

true

A technician is reconstituting a 10 ml vial of Doxorubicin powder with 5 ml of normal saline. In which location should the technician prepare the reconstituted product?

Class II biological safety cabinet

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

Containment ventilated enclosure

A closed front C-PECs (gloveboxes that can be located in a buffer room (SEC) but are often located in a C-SCA is called a:

Containment aseptic containment isolator (CACI)

A hospital pharmacy director is designing a new compounding cleanroom for preparing sterile and non sterile hazardous drugs within the same buffer room. Which of the following plans for containment primary engineering controls is compliant with USP standards?

Two C-PEC each dedicated for either sterile or non sterile products separated by at least 1 meter

True or False: Sterile and non sterile hazardous drugs can be compounded in the same buffer room if there are separated and dedicated C-PECs spaced at least one better apart

true

True or False: C-PECs, C-SECs and C-SCAs must have negative air pressure

true

True or False: Turbidity on or before day 14 indicates that contamination is present. If the liquid stays clear after 14 days of incubation, the compounder passed the test

true

True or False: If there is a power outage all compounding must stop and the PECs will need to be cleaned with a germicidal detergent and then disinfected with sterile 70% isopropyl alcohol prior to re-initiation of compounding activity

true

True or False: PECs are cleaned from top to bottom, back and front. This means that the cleanest areas will be cleaned first and the dirtiest areas will be cleaned last

true

Deactivation and Decontamination:

2% bleach (sodium hypochlorite) or peroxide - reduce HD toxicity, then remove HD residues

Disinfection:

Disinfection:

Sterile 70% isopropyl alcohol - inhibits or destroys microorganism required steps in sterile compounding

After an eye exposure to a drug or chemical, what is the minimum number of minutes that the eye should be flushed out in the eyewash station?

15

A drug wholesaler delivers a plastic tote containing chemotherapy drugs to the pharmacy. Upon opening the tote, the technician discovers that the drugs are not wrapped in plastic. What personal protective equipment should the technician what when unpacking this tote?

Elastomeric half mask with a multi gas cartridge and P100 - filter

A pharmacist is compounding an allergen extract solution that will be administered to a patient SC. Which of the following compounding standards should the pharmacist follow?

USP 797

What is the purpose of using a closed transfer device?

Is a drug transfer device that prevents the escape of hazardous drug fumes and particles that could endanger personal during manipulation such as compounding or drug administration

PPE for sterile hazardous drug compounding includes:

Head covers, a face mask and beard covers

Two pairs of shoe covers

A gown impermeable to liquids

Two pairs of ASTM D6978 (chemotherapy) rated gloves

A full face piece respirator or a face shield with goggles when there is a risk for spills or splashes

Rank the following steps of garbing for sterile compounding in the correct order.

Don shoe covers, hair covers and face mask

Perform hand hygiene with soap and water

Don gown

Clean hands with an alcohol based surgical hand scrub

Don gloves

What type of gloves are required when preparing non hazardous sterile compounds?

One pair of sterile; powder free gloves

Which of the following statements is correct regarding cleaning and disinfecting the pharmacy's sterile compounding area?

Shelving, bins and chairs should be cleaned monthly

The PEC is cleaned with a germicidal detergent followed by sterile 70%

Counters and floors are cleaned daily

Lint free sterile wipes are used to clean the PEC

Laminar airflow in a sterile compounding hood describes airflow that is:

Unidirectional

Where do the pharmacy personnel don garb for sterile compounding?

Anteroom

How often should a laminar airflow bench cleaned when making compounded sterile products (CSPs)?

Every 30 minutes

Before each shift

Before and after each batch of CSPs

The pharmacist will be compounding potassium chloride in normal saline for intravenous infusion. Where should hand washing take place before sterile compounding?

Anteroom

The technician is cleaning the cleanroom suite prior to leaving for the day. Place the following in correct order for cleaning and disinfection.

Clean the ceiling of the PEC

Clean the sides of the PEC, including the grill over the HEPA filter

Clean the work surface of the PEC

Clean the counters and floors in the SEC

Clean the ante area

USP requires periodic testing of the surface involved in sterile compounding. Which of the following statement/concerning surface testing is/are accurate?

Tryptic soy agar is used as the growth medium

Testing should occur at the end of the day

Surfaces regularly exposed to staff should be tested

At least one surface sample must be taken for each ISO 5, 7, 8 area