sterile compounding 031717 · • without proper technique and cooperation from the compounding...

Sterile CompoundingJessica Tagerman, PharmD, Rph

What is Sterility?

Sterility & Sterile Compounding

• Sterile = free from bacteria or other living microorganisms; totally clean

• Sterile compounding is the preparation of custom medications to prevent contamination and maintain patient safety

What types of formulations require sterile compounding?

Think of: Baxter Products!

Dianeal!

Extraneal

Minibag, Prefilled Syringes, Vial, Ampule

Minibag Piggybacked onto LVP

Parenteral Bags

Types of Compounding Products• Parenteral Products: Products that bypass the enteral system• Large volume parenteral (LVP)

• Volume greater than 100 mL

• Generally the fluid is the treatment

• Small volume parenteral (SVP)• Volume less than 100 mL

• Medication is the treatment

• Can be piggy backed onto LVP’s

• Includes minibags

In order to really understand the process of sterile compounding, we are going to compare it

to…

A VIP Club!

The VIP ClubEvery club has rules and

expectations. What resources can you use to find out more information before you go?

Researching the VIP club..

Word of mouth…Facebook..

Yelp..The VIP Club website..

Sterile Compounding

Sterile compounding also has rules, regulations, and

expectations. Where can you go to find this information?

USP 797• USP 795 = non-sterile compounding procedures and guidelines

• USP 797 = sterile compounding procedures and guideline

• First 1000 chapters are enforceable by agencies such as the FDA and TJC

Hint!

We learned non-sterile compounding before sterile

compounding. 795 comes before 797!

The VIP ClubEvery club worker has a specific

job function. Without proper training of these employees,

patrons of the club may become unsatisfied, rowdy, or dangerous.

Sterile Compounding

Personnel training is also VERY important in sterile compounding!

Sterile Compounding Personnel Training

• Without proper technique and cooperation from the compounding technician, a product will not actually be sterile.

• Training must be documented before an individual starts sterile compounding• Didactic training, written assessments, skills assessment, and media-fill test are

all required to prove competency

The VIP ClubWhat do you do at the VIP club?

Sterile CompoundingWhat do you do in order to compound a sterile product?

(In other words, what techniques are used in sterile compounding?)

Working With Vials & Ampules

Vials Ampules

Working with Vials

• Two types of vials containing active drug

• containing solution

• containing lyophilized powder

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Withdrawing solution from a vial (no reconstitution necessary)

• Introduce into the vial a volume of air equal to the volume of solution to be removed

• draw solution into a syringe; remove air bubbles

• plunger and tip of the syringe are sterile and must not be touched

Preparing Reconstituted Medications• Reconstitution: Mixing a liquid and powder to form a

suspension or solution

• Solvent: Liquid; what is used to dissolve the powder (diluent)

• Solute: Powder being dissolved

• Solution: Liquid + Powder

• Add solvent in small portions to solute

• Check for signs of incompatibility (precipitate, change in color)

• Add a BUD date/time + Shake well auxiliary label

Preventing Coring

• Place vial on flat surface.

• Position needle point on closure surface at ~ 45°angle.

• Press down on needle while gradually bringing it to an upright position (90° angle).

© 2016 Perspective Press/Morton Publishing Company 24

Preventing CoringCoring: When a needle damages the rubber closure of a parenteral container causing fragments of the closure to fall into the container and contaminate its contents

• Gently tap top of ampule to bring medication to lower portion of ampule.

• Clean neck with alcohol swab; grasp ampule between thumb and index finger at the neck while keeping swab in place.

• Forcefully snap neck away from you.

© 2016 Perspective Press/Morton Publishing Company

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Opening an Ampule

Ampules, Transferring Solution

• Tilt ampule down ~ 20°.

• Attach filter needle to a syringe and insert into ampule. Withdraw solution keeping needle submerged to avoid drawing air. Withdraw needle and remove all air bubbles.

• Exchange filter needle and transfer solution to final container.


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Syringes & Needles


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Basic Parts of a Syringe

Measuring Volume

Syringe Sizes1 mL to 60 mL

Syringes & Needles, cont’d


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Basic Parts Of A Needle

Needle Lengths3/8” to 3+”

Needle Gauges27 – 13

The LOWER the gauge, the THICKER the needle

Needle‐Free DevicesVial Adapters


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Needle Recapping• Should not be done unless absolutely necessary

• Use the one-handed scoop method

• Should NEVER be done for vaccines – why?

The VIP ClubVIP Clubs have very specific

floor plans to ensure exclusivity and customer satisfaction…

Step 2 Step 1

Step 3 Step 4

Compounding pharmacies also have

very specific floorplans/building

requirements to ensure sterility..

You can’t have a good time at a club without certain things….

Just like you can’t perform

sterile compounding without certain

things.

Primary Engineering Controls for

Sterile Compounding

Primary Engineering Controls• A device that provides appropriate air quality for compounding sterile preparations

Biological safety cabinets (bscs) Laminar airflow workstations (LAFW)

Types of Laminar Flow Hoods• Horizontal: Air is pushed towards the personnel completing the compound

• Vertical: Air is pushed to the bottom of the hood

• Used for hazardous substance compounding (chemo)

Standard Operating Procedures, Laminar Flow Hood

• Supplies in the hood are disinfected with 70% isopropyl alcohol

• No objects should be between the first air from a HEPA filter and the critical site

• Procedures are performed to reduce touch contamination; gloves are disinfected with 70% isopropyl alcohol

• All rubber stoppers of vials, bottles, and ampule necks should be wiped with 70% isopropyl alcohol for at least 10 seconds before preparing CSP

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Cleaning Frequency• Hood: beginning of each shift, before each batch, no

more than 30 minutes after last cleaning while compounding, after spills, when contamination is known or suspected

• Counters and work surfaces: daily

• Floors: daily

• Walls, ceilings, and storage shelving: monthly

What’s wrong with this picture?

Biological Safety Cabinets (BSCs)

• Enclosed, laboratory workspace• Protect personnel and the environment

• 3 classes• a Class II, Type A1 cabinet is the minimum recommended environment for preparing chemotherapy agents

A Class II, Type A1 Biological Safety Cabinet

Types of Biological Safety Cabinets

• A hoods: Recirculate a portion of the air (after 1st pass through HEPA filter) within the hood and exhaust a portion of the air back into the buffer room

• B1 hoods: Expel most of the contaminated air through a duct to the outside atmosphere and passes through a HEPA filter

• B2 hoods: Remove all contaminated air to the outside atmosphere after passing through HEPA filter. Air is not recirculated OR returned to the buffer room

• B3 hoods: Use recycled air within the hood. All exhaust air discharged to outside atmosphere. Type A hoods can be converted to type B3.

The VIP ClubLet’s go back to the rules and

regulations of the VIP club. Here is what you read during your initial research of the club:

No fighting, no inappropriate behaviors, total intoxication will not be tolerated, if you need to get sick, only do it in the bathroom.

What are the rules, regulations, and standard operating procedures of a sterile compounding

pharmacy?

Standard Operating Procedures• Access restricted to qualified personnel• Cartoned supplies decontaminated using spray disinfectant• Not frequently used supplies stored in anteroom• Carts used to bring in supplies not rolled past anteroom• Supplies disinfected before being brought into buffer room• Nonessential supplies that shed particles not taken into buffer room• Traffic in and out is minimized• No outer garments/accessories to be worn• Hands and forearms washed with soap and water for at least 30 seconds• Must wash hands before putting on gloves• No food, drink or gum

Procedures for Preparing IV Compounds• Flow hood should be turned on at least 30 minutes prior to starting• Wear Personal Protective Equipment (PPE)• Clean the hood, pole to hang IV bags, and sides of hood by moving from

top to bottom and back to front (down, then forward)• Collect supplies

• Check for expiration dates and leaks

• Remove dust coverings first

• Pre-sterilized needles, syringes, and filters

• Position supplies in hood• Critical areas should always be exposed to air flow

Responsibility of Personnel• Opened or partially used products must be stored under restricted

access• Devices and equipment are clean, accurate and effective• Packaging is appropriate for maintaining sterility and strength until

BUD• Labels on CSPs list names and amounts/concentrations of active

ingredients• Before dispensing, the clearness of a solution is visually confirmed• BUD’s assigned based on testing and obtaining information from

reliable sources (Trissels)

The VIP ClubWhat do you wear?

Sterile Compounding

What do you wear when you’re performing sterile compounding?

Garbing- Step 1

Hand Washing- Step 2

“Gloving”- Step 3

Additional Sterile Compounding

Types of Injectable Water

• Purified water USP: not intended for parenteral administration. Used to reconstitute oral products

• Water for injection USP: Not sterile, cannot be used in aseptic compounding of sterile products

• Sterile water for injection USP (SWFI): sterilized, but has no antimicrobial agents. Can be used in parenteral solutions.

• Bacteriostatic water for injection USP: Sterile water with antimicrobials, can be used for injection

• Sterile water for irrigation USP: sterilized but has no antimicrobial agents, used as an irrigating solution

Types of Solution

• Normal Saline (NS) 0.9% NaCl (isotonic)

• ½ Normal Saline (1/2 NS) 0.45% NaCl (hypotonic)

• ¼ Normal Saline (1/4 NS) 0.225% NaCl (hypotonic)

• 5% Dextrose in water (D5W) 5 grams dextrose per 100 mL

• 10% Dextrose in water (D10W) 10 grams dextrose per 100 mL

• 5% Dextrose in normal saline (D5NS)

• Lactated Ringer Solution (LR)

• Sterile Water (SW)http://ecatalog.baxter.com/ecatalog/loadcategory.html?cid=20016&lid=10001&hid=20001&categoryId=38453

Preparing Antineoplastics (Chemo)

• Must be done in a vertical flow hood• Must wear special clothing• Surface should be covered in plastic-baked absorbent

paper which is then disposed of in hazardous waste• Double gloves• Closed front surgical gowns• Sterile alcohol pledget wrapped around needle and vial

top during withdrawal• Cautionary labels affixed to medication bags

Preparing Total Parenteral Nutrition (TPN)

• Normally contains 50% dextrose, 10% amino acids, and 20% fat

• Aseptic technique is REQUIRED, it is infused into the right atrium of the heart

• Automatic TPN compounders can be used• May be premixed from the manufacturer, however

electrolytes, vitamins, and medications must be added to the bag as needed

Preparing Radiopharmaceuticals• May be diagnostic or therapeutic

• May be oral, IV, or inhaled

• Quality control tests are performed to ensure it is sterile, pyrogenfree, and pure

• Proper handling of isotopes during preparation must be ensured

• Must be prepared in vertical flow hood

• Strict packaging requirements, including being shipped in specific containers

• Safety principles of time, distance, and shielding are observed

• Special training must be completed (nuclear pharmacy)

Special Solutions• Total parenteral nutrition (TPN) solutions

• hypertonic admixtures of dextrose, fat, protein, electrolytes, vitamins, and trace elements

• TPN preparation systems

• TPN administration

• Dialysis Solutions

• Peritoneal dialysis solutions

• Irrigation Solutions

• Surgical, urological

• glycine, and sorbitol


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Handling and disposal requirements

Types of Waste• Solid: Any solid, liquid, or gas waste• Hazardous: Any substance capable of adverse effects on

the health and safety or the environment of a human being

• Regulated by OSHA

• All employees must be aware of risks and precautions

• Must keep SDS’s for all materials

• Infectious: includes blood, blood products, bodily fluids, sharps, laboratory waste

Waste Characteristics• Ignitability: Flash point less than 60 C

• Potassium Permanganate

• Silver Nitrate

• Collodion

• Corrosivity: pH less than 2 or greater than 12.5• Glacial acetic acid

• Sodium hydroxide

• Reactivity: Liable to explode, react violently, or release toxic gases when in contact with water• Nitroglycerin

• Toxicity: Contains a regulated substances at a concentration above the limit• Zinc

• Selenium

Hazardous Drugs (Hormones, Chemo)

• Wear doubled gloves• Inner glove beneath the cuff, outer glove above it

• Never touch gloves with skin

• Changed hourly or after every contamination

• Use leur-lok syringes• Special chemo sharps container• Must be put into hazardous waste bins• Must be prepared in a vertical flow hood (BSC)

Radioactive Waste

• Regulated by Dept. of Transportation (DOT)

• Container must have a warning label

• A placard must be placed on the vehicle if it carries Yellow III material

• Materials must be braced inside vehicle

USP 797 Terminology • Ante-room: All preparations for IV compounding are gathered in this area

(labels, gowning, and drug materials)• BUD: Beyond use date• Buffer area: An area where hoods are kept and sterile compounding takes

place• Clean area: a space where microbial containment is kept at specific levels

to ensure cleanliness• Compounded Sterile Product (CSP): a sterile drug product prepared by

compounding prior to administration• Critical site: An area exposed to air or touch, such as a vial, needle, or

ampule• Direct compounding area (DCA): a critical area within an ISO class 5

Terminology Continued• Media-fill test: A test performed on compounded products to ensure no

contamination has occurred during prep• Negative-pressure room: a room in which air flows into the room and

away from adjacent rooms, which results in positive pressure in the room• Positive-pressure room: A room in which air flows out of or toward

adjacent rooms, which results in a lower pressure in the room• ISO (international standards organization) Class 5: no more than 100

particles 0.5 microns or larger per cubic foot of air (most sterile)• ISO Class 7: no more than 10,000 particles 0.5 microns or larger per cubic

foot of air• ISO Class 9: no more than 100,000 particles 0.5 microns or larger per

cubic foot of air

What happens if a product that is supposed to be

sterile isn’t?

Questions?!

sterile compounding 031717 · • without proper technique and cooperation from the compounding...

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