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Chapter 16: Aseptic Technique, Sterile Compounding,

and IV Admixture Programs

Learning Outcomes
Describe basics of intravenous drug therapy
Describe key elements of working in laminar airflow

workbenches
List types of contamination in a laminar flow hood &
describe how to minimize their risks
Perform basic manipulations needed to prepare a
sterile product by using aseptic technique
Describe the risks of handling cytotoxic & hazardous
drugs

Learning Outcomes
List steps in drug preparation & handling that are

unique to cytotoxic & hazardous drugs


List typical ingredients of total parenteral nutrition
solutions
Describe manual & automated means of preparing
total parenteral nutrition solutions
Describe benefits of having a formal intravenous
admixture program
Describe how USP 797 has impacted preparation of
sterile products

Key Terms
Aseptic technique
Biological safety cabinet
Coring
Free flow protection
HEPA filter
Laminar airflow workbench (LAFW)
Large volume parenteral (LVP)
Total parenteral nutrition (TPN)
Small volume parenteral (SVP)

Parenteral Drug Administration


Parenteral not through digestive tract
Intravenous (IV)
Intramuscular (IM)
Intrathecal (IT)
Epidural
Intraarticular
Intraarterial
Intraocular
Intraperitoneal
Subcutaneous (SQ, SC, SubQ)

Risks of Intravenous Therapy


Infection
Air embolus
Bleeding
Allergic reaction
Incompatibilities
Extravasation
Particulate Matter
Pyrogens
Phlebitis

Types of IV Administration
Infusions
Continuous
Intermittent

IV Containers
Large Volume Parenterals (LVPs)
Small Volume Parenterals or Piggyback Systems
Add-Vantage
Vial Spike Systems
Flexible Plastic Bags
Glass Containers

Basic Continuous IV Therapy


Large volume parenteral (LVP)
hung on an IV pole 36 inches above patients bed
flow maintained by gravity
Sterile tubing attached to LVP
primary IV set
Catheter in patients vein

LVP
Usually a simple solution of
dilute dextrose
sodium chloride
or combination of both
Additives
swab rubber stopper with alcohol & let dry
inject drug into fluid
remove bottle vacuum

Non-coring Technique

Administration Systems
Continuous Infusions
more effective & less toxic than when given
intermittently
basic fluid & electrolyte therapy
blood products
drugs that require tight administration control
Intermittent Injections
periodic administration increases efficacy
reduces toxicity

Pre-Mixed Admixtures
Manufactured LVPs with additives
stable in solution for longer periods of time
available in many of sizes (250 mL, 500 mL, 1000 mL)
Examples
lidocaine
potassium
nitroglycerin
dopamine
aminophylline

RTU Advantages
Reduce handling by pharmacy
Reduce potential for contamination
Emergency situations-stocked in patient care area
Standard concentrations of IV medications
decrease potential medication errors in compounding &
administration

Pharmacy Prepared Admixtures


Volumes (100 mL, 250 mL, 500 mL, or 1000 mL)
Containers (glass, plastic, bag, bottle or syringe)
Syringe Systems
syringe pumps
volume control chambers
gravity feed
intravenous push systems

Syringe Systems
Pharmacy fills syringes with drugs & labels
stability in syringes related to drug concentration
Syringe Pumps
adjusted to administer volume over given period of time
pumps are operated by battery or compressed spring
may administer single dose or pre-programmed intervals
doses must be sent from pharmacy in standard syringe
sizes & concentrations

Electronic Infusion Devices


Electronic infusion devices
increase precision & accuracy
in fluid restricted patients
when drug must be administered at precise rate
Smart pumps alert user to problems
infusion settings outside recommended range
updates may be sent to pumps
pump log data may be sent to information system

Volume Control Chambers


Buretrol or Volutrol
Syringes used to administer drugs through volumetric
chamber
drug injected through port on top of chamber
solution added from primary LVP
minimal amounts of fluid can be given per dose
beneficial in fluid-restricted or pediatric patients
important that medication is followed by IV flush

Gravity Feed
Syringes can use gravity to administer drugs
vented set allows air to enter syringe
inexpensive & requires no other special equipment
Intravenous Push
injected directly into IV tubing
primary IV set is usually clamped off
Drug delivered directly to patient
Rapid onset of effects of drug

Patient Controlled Analgesia


Very effective in managing pain
Patient administers dose as soon as pain felt
Reduces nursing time
Pump programmed
Basal rate
Bolus when patient pushes button
Example: max 1 mg of morphine every 15 minutes

If patient pushes button in 10 minutes, drug not released but


attempt recorded so that pump tracks if pain not controlled

Unique Infusion Devices


Implanted pump
drug reservoir for continuous low-dose chemotherapy
administration
Elastomeric infusion device (EID)
acts as its own pump
pressure of container forces drug through tubing

Administration Sets
Primary IV Set
attached to the LVP
can be one of several varieties
Drip chamber-estimate administration rate by

counting drops as they fall through chamber


Drip chamber
macrodrip or minidrip
based on size of drop
tubing is labeled according to number of drops it

produces from 1 milliliter of solution

Drip Sets
Macro-drip sets deliver 10-20 drops per 1 mL
Minidrip sets deliver sixty drops per 1 mL
Rate controlled by roller clamp or electronic infusion

device
Drugs injected through ports
either Y-sites or flashballs

Venous Access Devices


Peripheral insertion most common
Peripheral catheters-limitations on what can be

infused & at what rate


Central catheter
more complicated
riskier to insert & maintain
fewer restrictions

concentration of drug
rate of administration
time venous access can remain in place

Peripheral Catheters
Plastic-flexible & most comfortable for patient
Steel needle with short end of tubing
scalp vein or butterfly
may be left in the patients vein if flushed
Central catheters
temporary or permanent
access vein with high blood flow

Catheter Examples
Permanent catheters
Hickman
Broviac
Port-a-cath
Peripheral catheter
peripherally inserted central catheter (PICC)
PICC inserted peripherally
flexible catheter threaded through venous system & its
tip ends near heart
high volume of blood flow

IV Miscellaneous Information
Heparin Lock
maintain catheter access to vein
resealable rubber diaphragm
provide port for intermittent use
concentration of heparin used in heparin locks is usually
10 units/mL or 100 units/mL
Needleless Systems
reduce risks of needle sticks
required in some states & some healthcare systems

IV Misc. Information Continued


Final Filters
located in the tubing
used to remove particles in IV solution
used with drugs that have a risk of particulate matter or
crystals in final solution
examples of drugs requiring filters

phenytoin
mannitol

Aseptic Preparation
Admixture preparation program includes:

1. Development & maintenance of good aseptic technique in


personnel who prepare & administer sterile products
2. Development & maintenance of sterile compounding area,
complete with sterilized equipment & supplies
3. Development & maintenance of skills needed to properly
use laminar airflow workbench (LAFW) or laminar airflow
hood

Aseptic Technique
Manipulating sterile products without compromising

their sterility
proper use of LAFW
strict aseptic technique

Conscientious work habits

Sterile Compounding Area


Compounded sterile products (CSPs) must be free of
living microorganisms
pyrogens
visible particles
Reduce number of particles in air
no cardboard in clean room
Clean work surfaces & floors daily
Clean walls, ceilings, & shelving monthly

Sterile Compounding Area


Segregate compounding area
minimize traffic in sterile compounding area
remove trash d frequently & regularly
Filter incoming air
Ultraviolet irradiation
Air-lock entry portals
Sticky mats

Sterile Compounding Area


Use anteroom for non-aseptic activities
order processing
gowning
handling of stock
ISO Class 5 environment
no more than 100 particles per cubic foot that are 0.5
micron or larger in size
LAFWs are used to achieve an ISO Class 5 environment

Laminar Airflow Workbenches


Principle of LAFWs
twice-filtered laminar layers of aseptic air
continuously sweep work area inside hood
prevents entry of contaminated room air
2 common types of LAFWs
horizontal flow
vertical flow

IV Hoods
Vertical Hoods used for
preparing hazardous
medications
Designed to protect preparer
from exposure to hazardous
medications
Horizontal Hoods most common
for sterile preparation of IV
solutions

Horizontal LAFW
Air moves from back to front
Electrical blower draws room air through a prefilter
Removes gross contaminants
Should be cleaned or replaced on regular basis
Prefiltered air moves through final filter
Entire back portion of hoods work area is HEPA
high efficiency particulate air
Removes 99.97% of particles that are 0.3 micron or

larger

Vertical LAFW
Air emerges from the top and passes downward
Exposure to airborne drug particulates minimized
Used for preparation of antineoplastics
Referred to as biological safety cabinets (BSCs)
Space between the HEPA filter and the sterile object
critical area.
Must prevent downstream contamination
Zone of turbulence

LAFW Principles
Position away from excess traffic, doors, air vents, etc.
Must run for 15 -3o minutes if turned off & back on
All interior working surfaces should be cleaned
70% isopropyl alcohol/other disinfecting agent
clean, lint-free cloth

Cleaning LAFWs
Clean sides of hoods using up & down direction
start at HEPA
work toward outer edge of hood
Order of cleaning
walls 1st
floor of hood 2nd

Cleaning LAFWs
Frequency
beginning of each shift
before each batch
not longer than 30 minutes following previous surface
disinfection when ongoing compounding activities are
occurring
after spills
when surface contamination is known or suspected

Cleaning LAFWs
If materials not soluble in alcohol, initially use water
follow with alcohol
Do not use spray bottles of alcohol in hood
Let alcohol air dry
Clean Plexiglas sides -warm, soapy water
Alcohol will dry out Plexiglas
clouds & cracks

Additional LAFW Instructions


Nothing should come in contact with HEPA filter
Nothing in hood that is not essential IV preparation
no paper, pens, labels, or trays
No jewelry on hands or wrists
Talk & cough away from LAFW
No smoking, eating, drinking in aseptic area
Manipulations at least six inches within hood

Additional LAFW Instructions


Must test LAFWs at least every 6 months
Also test if hood moved, or if filter damage suspected
Specific tests

airflow velocity
HEPA filter integrity

Strict aseptic technique must be used

Aseptic Environment
Personal Attire -Cover
Shoes, head & facial hair, use face masks/eye shields
cover scrub suits when leaving pharmacy
Handwashing
touch is most common source of contamination
scrub hands, nails, wrists, forearms to elbows for at least
30 seconds with a brush, warm water, & appropriate
bactericidal soap
Gloving
only sterile until they touch something unsterile

Equipment & Supplies


Syringes

Syringes
Volume of solution- 1/2 to 2/3 of

syringe capacity
Measuring-line up final edge to
calibration mark on barrel
Open syringe package in hood to
maintain sterility
Peel wrapper & discard out of hood
Leave syringe tip protector in place
until time to attach needle
To attach needle to Luer-lock-type
syringe turn is usually sufficient to
secure needle to syringe

Needles
Note components
Often color-coded=gauge
Vented needles
Filter needles
Dead space

Vials
Rubber stopper
Powders or liquids
70% isopropyl alcohol
Avoid coring
Normalize pressure
Reconstitution
SDV or MDV
Preservative considerations

Ampules
Move fluid to body of

ampule
Swab neck with
alcohol pad
Break at neck
Tilt ampule, needle
bevel down
Use filter needle

Prefilled Syringes
Manufactured ready-to-inject syringes
Commonly given IM, IV, or subcutaneously
Convenient for administration
emergency situations
Most likely to be kept in patient care areas

Preparation of IV Admixtures
Pharmacist inputs order into computer system
Assemble all materials & visually inspect
Clean hood-only needed products in hood
Disinfect all injection surfaces
Withdraw & measure drug fluid
Remove air bubbles from syringe
Discard syringes & uncapped needles
Recapping needles is generally unsafe practice
use one-handed scoop method if recap needed

Closures & Seals


Luer Tips for syringes when final product being

dispensed is not intended for injection


oral
topical

IV port seals
Tamperproof caps

Automated Compounding
Sterile product preparation is technically complex
Verification challenging
Automation can eliminate preparation errors
Enclosed IV preparation environments & robotics
used in high volume situations
or may prepare patient specific doses

Labeling of IV Preparations
Patient name, identification #, room #
2. Bottle or bag sequence number
3. Name & amount of drug(s) added
4. Name & volume of admixture solution
5. Final total volume of admixture
6. Prescribed flow rate (in milliliters per hour)
7. Date & time of scheduled administration
8. Date & time of preparation
9. Expiration date
10. Initials of person who prepared/checked IV admixture
11. Auxiliary labeling
12. Bar coding
1.

Beyond Use Date (Exp Date)


Label & final sterile product- validated by registered

pharmacist
Label with beyond use date (BUD)
stability
sterility

Policies & procedures


substantiated by

references
published literature
reasonable professional judgment

Cytotoxic & Hazardous Drugs


Hazardous agents
special procedures for labeling, storage, transport
special clothing
Biological Safety Cabinets (BSCs)
special handling of spills & waste
Additional information is available from ASHP
Technical Assistance Bulletin on Handling of Cytotoxic

and Hazardous Drugs

Protective Apparel
Disposable coveralls 0r or solid front gown
Low-permeability, lint-free fabric
Long sleeves & tight-fitting elastic or knit cuffs
Wash hands before putting on the gloves & after

removing them
One or two pairs of gloves may be required
Tuck one pair under cuffs of gown & place second pair
over cuffs

First Aid
Eyewash fountain in work area with hazardous drugs
Appropriate first aid equipment
Follow established first aid procedures
Obtain medical attention without delay & document

injury

Biological Safety Cabinet (BSC)


Type of vertical LAFW
Designed to protect workers
BSCs must meet standards set by National Sanitation

Foundation (NSF Standard 49)


Do not use horizontal LAFWs to prepare hazardous
drugs

BSC
Front air barrier-protects handler from contact with

hazardous drug dusts & aerosols


Types of Class II BSCs
Type A
Type B

BSCs must be operated continuously, 24/7


Inspected & certified every 6 months
Clean work surface, back, side walls with water or

cleaner recommended by cabinet manufacturer

BSC
Disinfect work surface with 70% isopropyl alcohol
Do not to use excessive amounts of alcohol
Treat cleaning supplies as hazardous waste
Decontaminate on weekly basis/immediately after spill
Refer to facilitys procedure on hood maintenance for

specific cleaning procedures & schedules

Preparing Hazardous Drugs


Same as regular drugs EXCEPT
attach & prime IV sets before adding hazardous drug
maintain slight negative pressure inside vial or use
chemotherapy dispensing pin
use syringes & IV sets with locking fittings
use oversize syringe for reconstitution
apply warnings on IV bag (Hazardous)
place IV in sealable bag to contain any leakage

Waste Disposal & Spill Cleanup


Spills-use spill kit
cleanup should follow established procedures
kits contain

protective gear,
eye protection
respirator
utility & latex gloves
disposable gown or coveralls
shoe covers
scoop, plastic container for glass fragments, absorbent spill pads,
gauze & disposable toweling, absorbent powder, & sealable, thick
plastic waste disposal bags

Total Parenteral Nutrition


TPNs aka hyperalimentation
Contain
carbohydrates
protein
fats
water
electrolytes
vitamins
trace elements

TPN Therapy
Meets nutritional needs for patients
who cant eat
who will not eat
who should not eat
who cannot eat enough to sustain their needs due to
increased nutritional requirements from their medical
condition

Components of TPNs
Base components
dextrose (carbohydrates)
amino acids (protein)
may also include fat & water
Additives
electrolytes
vitamins
trace elements (micronutrients)
drugs such as heparin, insulin, H2 antagonists

Components
Dextrose -usually a 50% or 70%
final dextrose concentration ~25% if via central vein
maximum of 1012.5% for peripheral administration
Protein usually 8.5%, 10%, or 15%
special formulations for pediatric patients, kidney
disease, liver disease, high stress situation (ICU pts)
Fats (or lipids)-10% or 20% fat emulsions
emulsions separately through peripheral IV line
or may be added to TPN solution: 3-in-1 solution

Components
Water
Electrolytes to meet daily metabolic needs
sodium, potassium, chloride, acetate, phosphate,
magnesium, calcium
administered as a specific salt of product
can cause precipitation: wrong sequence or
concentrations of electrolytes are added to bag
Vitamins- MVI for multiple-vitamin infusion
Vitamin K (phytonadione)
Trace elements for proper enzymatic reactions

Example of TPN Order


Dextrose

250 g
Amino acids
42.5 g
Sodium chloride
60 mEq
Potassium chloride
40 mEq
Potassium phosphate
20 mEq
Calcium gluconate
1g
Magnesium sulfate
1g
Trace elements
2 mL
MVI
10 mL
Total volume
1000 mL
Infuse at 100 mL per hour. Also give: Vitamin K 10 mg intramuscularly (IM)
every week,
10% fat emulsion 500 mL intravenously three times per week.

TPN Form
Preprinted order forms
Reduce error
May be required in some

hospitals
Each facility designs

components of
preprinted forms

Preparation of TPN Solutions


Automated compounder
2 primary versions of TPN compounders

1st-provides a separate compounder for base solutions and


electrolytes
2nd -uses one compounder to infuse all compounded
ingredients

Gravity fill preparation

Administration
Central line
immediate dilution of administered solution by blood
allows use of very concentrated solution
Peripheral parenteral nutrition (PPN)
same components as TPN
not as concentrated
may not meet all the patients nutritional needs

Pediatric IV Drug Administration


Doses individualized
calculated based on patients body weight
Intermittent doses via syringe through volume control

chamber or by using syringepump


maximize accuracy
Minimize amount of fluid

Calculations should be checked & double-checked

Epidural Administration
Special catheter into epidural space of spine
Drug injected at nerve ending-dose greatly reduced
All solutions must be free of preservatives
Epidural patient controlled analgesia
Continuous infusions
Bolus injections

Admixture Programs
Policies & Procedures
Space
Training
Equipment
Standard & Non-Standard Preparations
Labeling
Handling

Quality Assurance Program


ASHPs Technical Assistance Bulletin on Quality

Assurance for Pharmacy-Prepared Sterile Products


preparation
expiration dating
labeling
facilities
equipment

personnel education
training
evaluation
end-product testing

USP Chapter 797


Refer to USP Chapter 797, Pharmaceutical

CompoundingSterile Preparations
recommendations & regulations regarding IV
admixture programs
different levels of risk for products
fourth class, immediate-use CSPs
training

policies & procedures


garb, aseptic technique, process validation, end-product

evaluation