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Basics of Aseptic Compounding Technique

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Caitlyn Perez'

on 18 April 2014

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Transcript of Basics of Aseptic Compounding Technique

Basics of Aseptic Compounding Technique
Proper Gowning
Don't Touch
Dress from the head down
Gloves and booties should be worn over coverall sleeves and cuffs
Minimize motion
Minimize maintenance
Gowning Guidelines
Clean room (buffer room) is a secondary engineering control
Class 10,000 (ISO Class 7), Class 1,00 (ISO Class 6), Class 100 (ISO Class 5)
Sterile preperation should be compounded in Class 100 environments
Clean rooms include: special filtration for incoming air, ultraviolet irradiation, air-lock portals, sticky mats and positive room air pressure
Remove outer garments
Completely cover hair with hair net
Wear surgical mask
Completely cover shoes with shoe covers
Wash hands and arms
Place gown on
Wear long-gauntleted gloves pulled over cuff of gown; For hazardous compounding wear double gloves
Disinfecting the Work Area
Primary Engineering Controls
Vertical Hoods
Clean and sanitize ante-room weekly and shelving monthly
Wipe supplies in ante-room with a disinfecting agent and check periodically for contamination
Clean floors once daily
Routinely test air quality
Monitor air bioburden weekly for high-risk compounding and monthly for low and medium-risk compounding
i.e. Media-fill and endotoxin testing
Needles, Syringes and Filters
Coring- Allowing particulate matter to enter vial by sticking the needle into the rubber stopper improperly
Solution Containers
Hold drugs that are not compatible with plastic containers or rubber stoppers
USP Labeling Requirements for Sterile Compounding
Aseptic technique- Practices that help reduce the risk of exposure to personnel
Parenteral medications are given to patients who can not take oral medications, have difficulty absorbing medications, drug is not available in oral form or if they want a quicker onset of action
Examples of parenteral administrations include: IV, IM, IT, SQ and epidural
Risks of IV Therapy
IV Push- Given over a short period of time
IV Infusions- Given over extended period of time
Continuous Infusions
Intermittent Infusions (Short period of time)
Additive- Drug
Admixture- Final preparation
Human touch contamination is the most common source of contamination
Air Embolus
Allergic Reaction
Particulate Matter
Critical area- Space between the HEPA filter and the sterile object
First air- HEPA filtered air that runs through compounding work area
Zone of turbulence- Air turbulence created inside critical area caused by an object being placed in the direct path of first air
Laminar Airflow Hoods
Horizontal Hoods
Sweeps filtered air from back of hood to the front
Hand Washing Techniques
Remove jewelry
Turn on warm water
Wet hands, wrists and elbows
Scrub hands, nails, wrists and forearms for 30 seconds
Rinse holding hands upward
Use towel to turn off water
Don't touch anything except for garbing supplies
An electronic blower draws air through prefilter which collects only gross contaminants
The air is then blown through the plenum and through the High Efficiency Particulate Air (HEPA) filter
Proper Operation
Hood should be positioned away from excess traffic
All interior workspaces need to be wiped down with water and disinfected with 70% isopropyl alcohol cleaning in a top-to-bottom, back-to-front motion
Do not open anything towards the HEPA filter
Critical items should be placed close to the air source
Items shouldn't be any closer than 3 inches from the back of the hood
Primary engineering controls should be tested every 6 months
Sweeps filtered air from top downward through work area
Biological Safety Cabinets
Class I
Air flows through the front, across the work area, and out of the HEPA filter on top
Does not provide personnel protection or preparation protection
Class II
Air is drawn around personnel in through the front and down the laminar flow of the HEPA filter
Provides personnel, environment and preparation protection
Class III
Used for infectious agents
Cabinet is gas tight with non-opening windows and attached rubber gloves
Air is filtered in through one HEPA filter and out two others before being expelled
Provides highest level of preparation, environmental, and personnel protection
Choosing correct needles and syringe combination
When using 1 mL, 3 mL, or 5 mL syringe use a 20 gauge/1 inch needle
When using 10 mL, 20 mL, 30 mL, or 60 mL syringe use a 16 gauge/1.5 inch needle
When preparing large/viscous volumes use 16 gauge/1.5 inch needle
*As shaft gets bigger, gauge gets smaller
Three main parts: Shaft, hub and bevel (bevel heel and bevel tip)
Steps for Opening Needle Package
Position 6 in. inside hood
Tilt needle hub towards back wall
Holding middle of cap, pull package from top towards you never touching the shaft
discard packing into waste container
The barrel holds the drug, the plunger provides the pressure and the top collar prevents the syringe from slipping while using
When measuring with a syringe, the final edge should be lined up to the calibration mark on the barrel
Steps for Opening Syringe Package
Position 6 in. inside hood
Hold syringe by the barrel
Angle barrel tip towards back wall
Grasp top of packaging and twist/pull the packaging down
Discard of wrapper
Connecting Needles to Syringes
Place 6 in. inside workspace
Point needle and syringe towards back wall and remove packaging
Hold needle at midpoint and pull packaging down
Lay capped area of needle towards the back wall and discard wrap
repeat the same process for the syringe
Point the type towards the back wall and insert the needle hub onto the tip of the syringe
Remove cap and lay it inside the hood with the opening facing the back wall
Steps for Recapping and Discarding
Place cap on hood surface
Use one-handed method to aim needle towards opening of cap
Once inside, firmly lock cap onto syringe
Dispose in sharps container
Needlestick Injury
Unused Needle
Inform manager within 24 hours
Complete Record of Occupational Injury/Illness Form
Have injury checked
Used Needle
Inform manager immediately
Complete Record of Occupational Injury/Illness Form
Have injury checked
Return for follow-up
IV Admixtures
Opening Ampule:
Swirl ampule to move product to the bottom
Clean ampule neck with swab of alcohol and leave swab in place for breaking
Hold head with thumb and index finger of one hand and the body with the other
Push away from oneself but not towards HEPA and dispose of head in sharps
Assemble materials and inspect them for any defects
Disinfect all injection surfaces
Withdraw drug from container and measure
Pull back plunger, tap barrel to remove air bubbles and then push plunger back in
Compound final solution
Also known as hyperalimentation containing nutrients to sustain life i.e. carbohydrates, protein, fats, water, electrolytes, vitamins and trace elements
Base components are mixed first i.e. dextrose, amino acids and sometimes water and fat
Additives are mixed second i.e. electrolytes, vitamins and trace elements
Gravity Fill
Empty Bag Method- Starting with an empty bag that will eventually become the final container
Underfill- Bags that are partially filled with concentrated dextrose
Labeling in Institutional Setting
Name and concentration of drug
Final volume
Administration route
Storage Instructions
Initials of preparer
Patient's name and identification number
Patient's location
Name and amounts of drugs
Final volume
Time and date of schedule
Time and date of compounding and initials of compounder
Administration route
Administration instructions
Storage instructions
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