Sterile Compounding

sterile compounding

the preparation of medications in a sterile environment to prevent contamination and help provide better patient protection

- includes diluting, reconstituting, repackaging, mixing, and basically preparing drugs that must be uncontaminated or "free of microorganisms."

Eye drops

Irritations (liquid "washes" that go into a body cavity)

Baths and soaks for live organs

Solutions for implants

Injections: intravenous, intramuscular, subcutaneous, and intrathecal drugs

Sterile compounding is used to prepare:

USP

a nonprofit organization that sets the standards for medicine and compounding practices in the United States

USP 797

USP chapter for sterile compounding

Primary Engineering Control (PEC)

A device or room that provides ISO 5 air for compounding medications

Secondary Engineering Control (SEC)

The room around the PEC that maintains ISO 7 air

International Standard Organization: defines how clean the air must be [number + size of the particles per volume of air]

What is ISO?

ISO 5

Areas that are closest to the sterile drugs and containers have at least ISO _____ air quality.

ISO 7

The buffer room, which contains the Primary Engineering Control (PEC), must be at least ISO ____ air.

ISO 8

The anteroom, which is the room for handwashing and garbing, must be at least ISO _____ air.

ISO 7

ISO ____ air is required for negative to negative pressure buffer room

colony-forming units (CFU)

measures the number of living microorganisms in a sample

≤ 1 CFU/m3

ISO Class 5 Air has ≤ ____ CFU/m3 when sampling living air particles for air sampling

≤ 10 CFU/m3

ISO Class 7 Air has ≤ ____ CFU/m3 when sampling living air particles for air sampling

≤ 100 CFU/m3

ISO Class 8 Air has ≤ ____ CFU/m3 when sampling living air particles for air sampling

≤ 3 CFU

ISO Class 5 Air has ≤ ____ CFU when sampling living air particles for surface sampling

≤ 5 CFU

ISO Class 7 Air has ≤ ____ CFU when sampling living air particles for surface sampling

≤ 50 CFU

ISO Class 8 Air has ≤ ____ CFU when sampling living air particles for surface sampling

positive

The air pressure inside the PEC and the SEC are both ______ (positive or negative) for compounding non-hazardous drugs

positive air pressure

Which air pressure is used for compounding sterile products and ensures that the air flows out of the cleanroom to help keep the sterile areas free of microorganisms and particles?

negative air pressure

Which air pressure is used for compounding biohazardous products and chemicals?

800

Compounding hazardous products utilizes the USP <____> protocol.

laminar airflow workbench (LAFW)

compounding aseptic isolator (CAI).

List some examples of PECs

High Efficiency Particulate Air Filters (HEPA)

Help remove particles when the air in the sterile hood runs through the filter. It must be recertified by a specialist every 6 months.

cleanroom suite

a specific type of SEC that contains one or more PECs inside a buffer room (SEC) that is entered through an adjacent anteroom.

- has stricter air control

segregated compounding area (SCA)

a separate designated space that contains a PEC, but the surrounding room is not ISO 7 air

- used in facilities that cannot support a full cleanroom suite.

anteroom

a specific room in the SEC that connects the rest of the pharmacy to the secondary engineering room (SEC) or buffer room

- contains a sink, cabinets, and benches which are used for garbing for properly preparing to compound medications.

demarcation

Running down the center of the anteroom is the line of _____, which separates the dirty area from the clean area

c. Removes bacteria and particles from the air

What is the role of the HEPA filter in sterile compounding?

a. Adds humidity to the air

b. Filters out gases and odors

c. Removes bacteria and particles from the air

d. Sterilizes surfaces

a. No, as you cross over the line, you put one shoe on at a time

When you cross over the line of demarcation, do you put both shoes on at the same time?

a. No, as you cross over the line, you put one shoe on at a time

b. Yes, you put both shoes on at the same time

laminar airflow workbench (LAFW)

a type of PEC that provides ISO class 5 air or better for sterile compounding

- airflow can be either horizontal or vertical

horizontal = back to the front

The airflow in a laminar airflow workbench can either be horizontal or vertical. If horizontal, the HEPA-filtered air flows from the ____ to the ____

vertical = top to bottom

The airflow in a laminar airflow workbench can either be horizontal or vertical. If it is a vertical LAFW, the HEPA-filtered air flows from the ____ to the ____.

30 min

Before turning off the LAFW, it should run for at least ____ minutes.

compounding aseptic isolator (CAI)

a closed PEC system that has glove ports to separate the compounder from the product.

- uses HEPA-filtered air within the chamber.

Head cover/facial hair covers --- Face masks/eye shield ----- shoes or shoe covers ---- washing of the hands ----- put on the outfit --- put on the gloves

order of putting on PPE prior to sterile compounding

1. Make sure to clean underneath your fingernails under warm running water using a disposable nail cleaner.

2. Scrub soap on your hands all the way up to your elbows.

- Wash for 30 sec.

3. Rinse hands/forearms so that the water flows from the fingertips to the elbows.

4. Dry them using lint-free disposable towel

List the steps to washing your hands as a part of garbing for sterile compounding

true; wipe or rub sterile 70% IPA on all contact surface areas of the gloves

T/F: After garbing, gloves become contaminated when they touch sterile surfaces

d. 30 seconds

How long do you wash your hands as part of the garbing technique before entering the primary engineering room (PEC)?

a. 15 seconds

b. 35 seconds

c. 20 seconds

d. 30 seconds

6 months

In addition to the media fill test and the gloved fingertip test, other tests are used to help keep the compounding area free of contaminants, including air sampling, which uses an impaction air sampler to collect at least 1000L in each ISO 5 air PEC and in each classified room, ISO 7 buffer room, and ISO 8 air anteroom. It is conducted every ____ months.

at least once monthly

In addition to the media fill test and the gloved fingertip test, other tests are used to help keep the compounding area free of contaminants, including surface sampling, which is used to check that the key areas (PEC work station, counters, carts, gloves, and pass-through spaces) are free of microbial remnants after cleaning and disinfecting. How often is this performed?

≤ 20 °C

The SEC (buffer room) and SCAs must be kept at a temperature at ≤ ____°C.

≤ 60%

Humidity in the compounding room should be ≤ ____%

daily

Temperature in the CSP storage areas (ex. refrigerator, freezer) should be monitored at least ____.

12 months

Temperature monitoring devices must be calibrated at least every ____ months.

terminal sterilization

After a product is compounded and packaged, it goes through ______, a process of sterilizing a drug or product in its final sealed container. It provides a higher level of assurance of sterility besides using aseptic techniques because it's applied to the finished product, and helps to reduce the risk of contamination

steam (autoclaving)

What is used for the sterilization of aqueous, heat-stable products such as 0.9% NS and dextrose solutions?

dry heat

What is used for the sterilization of oils, powders, and glassware?

radiation

What is used for the sterilization of heat/moisture-sensitive products?

gas: ethylene oxide

What is used for the sterilization of equipment (rarely used)?

filtration (0.22µm)

What is used for the sterilization of heat-labile drugs, such as insulins and other injectables?

30 minutes

The PEC is cleaned daily and anytime contamination is suspected. Sterile 70% IPA is applied to the work stations throughout the day, every ____ minutes while working.

1. Clean the ceiling of the hood from back to front

2. Clean the back of the hood (over the grill, over the HEPA filter), from top to bottom

3. Clean the IV bars and hooks

4. Clean the sides of the hood, wiping it from back to front in long sweep motions

5. Clean other equipment that is kept in the hood

6. Clean the bottom surface starting from back to front, with a side-to-side motion

Steps to cleaning the PEC

true

T/F: It is important to check the temperature and humidity in the sterile compounding room because high humidity and temperature can promote the growth of bacteria and microorganisms, which could contaminate the sterile products

1. Review the medication order

2. Gather and examine all the materials needed to prepare the medication order.

3. Clean the hood properly; only have the necessary items in the hood

4. Prepare the sterile compound product using aseptic technique

5. Dispose of syringes, needles, and vials in the sharps container

6. Make sure that all sterile products are properly finished

7. Complete the terminal sterilization and/or sterility tests afterwards, if appropriate

Steps for preparing the CSP medication

6 inches

When placing items in the hood, take only what you need, leave space for airflow in the hood, and place items ____ inches inside the hood from the front edge near you.

first air

Always keep critical sites such as needles, syringes, IV bag ports directly in the ____ air (the unobstructed laminar airflow)

Beyond-Use-Date (BUD)

the date and time after which a compounded sterile product cannot be used and is thrown away or tossed

- Category of CSP (risk level based on the conditions of preparation)

- Storage conditions (room temperature, refrigerated, or freezer)

- Sterility tested

The Beyond-Use-Date (BUD) is determined by:

Category 1

Which category of CSPs is described below?

- prepared in an ISO 5 PEC environment that is placed in a segregated compounding area (SCA)

- shorter BUDs due to higher risk of contamination

- sterility testing required after product is made

≤ 12 hours

What is the room temperature BUD for a category 1 CSP?

≤ 24 hours

What is the refrigerated BUD for a category 1 CSP?

Category 2

Which category of CSPs is described below?

- prepared in a cleanroom suite

- sterility testing may be required

- preparation will have a longer BUD, depending on whether the test is passed

Category 3

Which category of CSPs is described below?

- must be made in accordance with specific requirements, which allows them to have longer BUDs, up to a max of 180 days

180 days

Category 3 CSPs have a maximum BUD of _____ days.

a. Category 1 CSPS

Which of the categories for CSPS has the highest risk of contamination and needs to have shorter BUDs?

a. Category 1 CSPS

b. Category 2 CSPS

c. Category 3 CSPS

master formulation records

In certain situations, sterile compounding records, such as master formulation records or compounding records, are required for each sterile product. The _____ records are created for multiple patients or when using nonsterile ingredients.

compounding records

In certain situations, sterile compounding records, such as master formulation records or compounding records, are required for each sterile product. _____ records must be created to document each CSP made during the compounding process. It is created for categories 1, 2, and 3 CSPs

• A sterility test, or bacterial endotoxin test fails

• If there is a compounding error is discovered that could result in patient harm once administered

• If the CSP is dispensed or administered before the sterility tests are made available

A recall for a CSP must be initiated if:

Standard Operating Procedure (SOP)

documented and contains all the details on the CSP, procedures to determine the severity of the problem, identification of the patients affected, and procedures for disposing of the medication.

- The recall must be reported to the appropriate regulatory bodies, which include: prescribers, the state board of pharmacy, the FDA, patients, and healthcare facilities.