Compounding

Into what two categories do compounding techniques fall into?

Communition and blending

What is communition?

Reducing a substance into fine particles

Into what two subcategories is communition further divided into?

Trituration and levigation

What is trituration?

Process of rubbing, grinding, or pulverizing substance to create fine particles, usually in mortar and pestle

What is levigation?

Process of decreasing particle size of a solid by incorporating a small amount of liquid levifating (wetting) agent

Levigating agents are used for what?

Used to “wet” an insoluble (unable to dissolve) solid enough to form a paste. This paste can be mixed into cream, gel or ointment

What are 3 common levigating agents?

Glycerin, propylene glycol, and ethyl alcohol

What is blending?

Combining two substances together

Into what 2 subcategories is blending further divided into?

Spatulation and geometric dilution

What is spatulation?

Process of mixing ingredients with a spatula, also known as folding

Spatulation is _________ than stirring, providing…

gentler, provides smooth and uniform mixture

What is geometric dilution?

Series of dilution steps to mix 2 or more ingredients. Smallest qty ingredient is added 1st, then same amount of 2nd ingredient and mix. Add same amount of next ingredient as in mixture, keep increasing until all mixed

What PPE can be reused, what must be disposed?

Reusable: gowns, goggles (but must be cleaned with 70% isopropyl alcohol)

Disposable: gloves, shoe covers, hair covers, beard covers, face masks

What is the correct USP to use when compounding hazardous drugs?

USP 800

What is CNSP?

Compounded, non-sterile preparation

What must the label of a CNSP include?

Storage conditions, BUD, and any prescription labeling requirements

What is BUD?

Beyond use date, last date or hour and date a patient may safely use a compound med

The BUD varies by…

Compounded product, depending on product stability, container, and potential for microbial growth

What is meant by products stability?

The ability for active ingredient to keep its strength

What USP contains guidelines for BUD regarding non-sterile compounds?

USP 795

What includes non-sterile compounding?

Adding flavor to meds, commercially available kits, reconstituting meds (UNLESS its provided in manufacturer’s label)

What does sterile mean?

Free of bacteria or other contaminants

What are 6 examples of sterile compounds?

Bronchial nasal inhalations, baths/soaks for live organs/tissues, injectables, irrigations for wounds, eye drops, tissue implants

What is nonsterile?

Where bacteria and contaminants are not a threat in causing significant harm to a patient

Who regulates nonsterile compounding?

Federal: United States Pharmacopeia (USP) 795 (nonsterile)

State: state boards of pharmacy, vary state by state

What is a MFR?

Master formulation record, also known as compound recipe

What is a CR?

Compounding record, or specific documentation each time a compound is made

According to USP 795, how long must documentation of process of compounding CNSPs be kept?

2 years

What are the two types of dosage forms?

Aqueous (use water in the mix) and nonaqueous (don’t use water in the mix)

What are the aqueous types of dosage forms?

Solutions, suspensions, creams

What are the nonaqueous types of dosage forms?

Capsules, tablets, powders, suppositories

How long do non-preserved aqueous compounds stored in regrigirator last? (BUD)

14 days

How long do preserved aqueous compounds stored in controlled room temp or refrigirator last? (BUD)

35 days

How long do oral liquids (nonaqueous) compounds stored in controlled room temp or refrigirator last? (BUD)

90 days

How long do other nonaqueous compounds stored in controlled room temp or refrigirator last? (BUD)

180 days

USP specifies that aqueous dosage forms have enough water for…

microbes to grow

When it comes to mortar and pestles, what are the different materials out there?

Glass, porcelain/ceramic, wedgewood, and electric

For what would you use a glass mortar and pestle? Why?

Liquid preparations, chemicals that are oily or stain, and chemotherapy agents. They are less porous and have less risk of cross contamination

For what would you use a ceramic/porcelain mortar and pestle?

Blending powders, pulverizing, or reducing particle size of soft materials and crystals

For what would you use a wedgewood mortar and pestle?

Best for reducing size of dry crystals and hard powder particles

For what would you use a electric mortar and pestle? Why?

Mixing only, not reducing particle size

What are syringes used for?

Measuring small volumes or thick liquids

Spatulas are used for mixing and what else?

Transferring of dry chemicals

What type of spatula materials are out there?

Stainless steel, hard rubber, and plastic

When are stainless steel spatulas avoided?

When using iodine, since it corrodes stainless steel

What USP publishes guidelines on hazardous compounding?

USP 800

What is needed when compounding hazardous drugs?

Cleanroom and laminar flow hood, plastic backed mat, sink, eyewash station

According to USP 795, when must work surfaces be cleaned?

At the beginning and end of each shift when compounding occurs, after spills, and when surface contamination is known or suspected

According to USP 795, when must floors be cleaned?

Daily on days when compounding occurs, after spills, and when surface contamination is known or suspected

According to USP 795, when must walls and ceilings be cleaned?

When visibly soiled, after spills (walls not ceilings), and when surface contamination is known or suspected

According to USP 795, when must storage shelving be cleaned?

Every 3 months, after spills, and when surface contamination is known or suspected

What are cleanrooms?

Used to prepare CSPs. They have filtered air to limit risk of contamination of your CSPs

Of what cleanrooms consist of?

Consists of anteroom and buffer room

What is the anteroom?

Where first steps of compounding process is performed, such as clothes changing and handwashing

What is stored in the anteroom?

Handwashing supplies (facility approved cleaners and lint free wipes). There is a limit of what is stored here due to sources of contamination

What is the buffer room?

Area where you’ll find PECs and where compounding is actually performed

What is used to clean buffer rooms?

EPA registered one step disinfectants

Cleanroom airs are maintained with…

HEPA filters and positive air pressure (prevents anteroom air from flowing into buffer room)

What are ISO classes?

Depict number of particles in the air. Lower ISO = lower particles in air

What ISO classes must anteroom, buffer room be?

Anteroom = ISO 8 or better

Buffer = ISO 7 or better

PEC = ISO 5 or better

What are primary engineering controls?

Specialized equipment that helps eliminate air particles that could contaminate your compounded sterile products

How do PECs sterilize air?

With high efficiency particulate airflow (HEPA) filters

All PECs must be a ISO class __ or better.

5

PECs are ran…

24/7 (if turned off, must be cleaned and disinfected)

What are the 5 types of PECs?

Laminar workflow bench (LAFW), compounding aseptic isolator (CAI), compounding aseptic containment isolator (CACI), biological safety cabinet (BSC), integrated vertical laminar flow zone (IVLFZ)

Laminar workflow bench (LAFW)

Most common type of PEC, only used for nonhazardous compounding, airflow is horizontal or vertical

Compouding aseptic isolator (CAI)

PEC with attached glove assemblies, non hazardous compounding

Compounding aseptic containment isolator (CACI)

Negative pressure and containment chamber, hazardous compounding allowed (like chemotherapy)

Biological safety cabinet (BSC)

hazardous or non hazardous compounding allowed

Integrated vertical laminar flow zone (IVLFZ)

Vertical airflow, integrated into roomn itself, only for nonhazardous

Depending on where HEPA filters are, that where the air flow goes. Explain which way air flows depending on filter.

Above compounder = vertical

Front of compounder = horizontal

HEPA filters must be inspected and certified every…

6 months

What are critical sites on a PEC?

Certain areas on a PEC that must receive uninterrupted airflow to remain sterile

In a PEC with horizontal airflow, how do we avoid shadowing critical sites?

Place items side by side, not back to back

In a PEC with vertical airflow, how do we avoid shadowing critical sites?

Dont stack items on top of one another

What is used to clean PECs?

Sterile EPA registered cleaning agent or isopropyl alcohol; low lint wipes

PECs are cleaned…(order)

Top to bottom

What are 3 common IV dosages?

IV push, IV piggyback, and large parenteral volume (LVP)

What is IV push?

When the drug is “pushed” into patients vein. Usually a small amount of liquid (1-20 mLs)

When is IV push usally used?

For opioids for rapid pain relief or antihypertensives for high blood pressure

What is a IV piggyback?

Small volume administered through patients IV line over short period of time (30 to 60 minutes)

What are IV piggybacks also known as?

Small volume parenterals, since they are below 250 mL

When are IV piggybacks used?

For opioids for controlled pain or antibiotics

What are large volume parenterals?

Large volume of liquid administered at a slow steady rate (infused), usually 1 liter or more

When are LVPs used?

To give patients fluids or meds that must be infused continuously (heparin, vassopressin, etc)

Aside from being sterile, epidurals must be…

Preservative free

What USP sets guidelines for sterile compounding?

USP 797

What are luer to luer connectors?

Used to transfer contents of one syringe to another. Used to split volume of one syringe into two syringes

The hub of a needle is…and connects in what two ways?

Part of needle that attaches to syringe tip. Either twists on (luer-lock) or slips on (slip-tip)

The _____, ______, ______ and _______ of the needle must NEVER be touched. What can be touched?

Hub, shaft, bevel, and tip. Only touch cap

What are the 6 common needle lengths?

1/2, 5/8, 1, 1.5, 2, and 3 inches

What needle length is most commonly used during compounding?

1 to 1.5 inches

Vials can be made up of…

Glass or plastic with a rubber stopper on top (critical site)

To prevent contamination, what can’t be touched in a vial?

Rubber stopper

What is a single dose vial (SDV)?

Don’t contain preservatives, must be discarded after 1st use

What is a multi-dose vial (MDV)?

Contain preservatives, can be punctured mutiple times, 28 days after first puncture, throw away (unless otherwise indicated)

When are ampules used for medication instead of vials?

Meds that are incompatible with vial’s rubber stopper, plastic, or other chemicals found in vials

How are ampules opened?

Dominant hand on top, break towards side wall of hood, don’t touch neck

What must be used to draw up fluid from ampules?

Filter needle, removes glass from solution

What are the 6 common needle gauges?

12, 16, 18, 22, 25, and 30