Download IV PREPARATION COURSE

Aseptic Technique, Sterile Compounding:
Intravenous and Admixture
Lecture #1
IV PREPARATION COURSE
Aseptic Technique
“Aseptic technique is the term used
for all procedures and techniques
performed to keep a sterile product
from becoming contaminated.”
Parenteral Drug Administration

Basic Intravenous Therapy
- Intravenous (IV) route of administrations is the most
common route that parenteral dose are administered
today.
- Other parenteral dosage forms are:
1. intramuscular (IM)
2. subcutaneous (SubQ)
3. intradermal (ID)
4. epidural
- IV fluid is in a large-volume parenteral (LVP), usually
more than 100 mL
Basic IV Therapy cont…
- Hang on an IV pole approximately 36 inches higher than
the patient’s bed.
- The LVP is usually a simple solution of dilute dextrose,
sodium chloride or both.
- Solution is infused continually to keep blood from clotting
in the catheter and plugging the line.
Basic IV Therapy cont…
- Primary IV set – attaches to the LVP. Most IV sets that
flow by the force of gravity have several common features:
1. Drip chambers are typically classified as macrodrip
or minidrip based on the size of the drop that is
formed in the drip chamber.
a. Macrodrip – deliver 10 to 20 drops/mL
b. Minidrop or Microdrip – deliver 60 drops/mL
2. Electronic infusion devices are usually used in fluid
restricted patients or when the LVP contains a drug
that must be administered at a precise rate that
cannot be monitored by using the gravity method.
Continued…
- Secondary IV sets – drugs that are routinely delivered
through the same basic IV setup are usually attached to
a “secondary IV set” connected to the primary set.
- Catheters – typically inserted into a peripheral vein (arm,
leg, or hand) or a central vein (in the chest near the
heart).
1. Where the catheter is inserted depends on the
contents of the IV
2. Peripheral insertion is more common than central
insertion
3. The central catheter is more complicated and riskier
to insert and maintain, but has fewer restrictions with
respect to type and rate of administration
Continued…
4. Types of peripheral catheters:
a. Plastic – most common
b. Steel – commonly referred to as a scalp vein or
butterfly. Used in patients that require IV therapy
who are still capable of eating and drinking, do not
require supplemental fluids, and might be ambulatory.
5. Central catheters can be temporary; used for days or weeks
(such as during a hospital stay) or permanent, when used
for months or years (such as home care or cancer patients)
Continued…
6. The central catheter gives direct access into a vein that
that has a high flow of blood.
7. Peripheral inserted central catheter (PICC) offers some of
the benefits of both central and peripheral catheters.
Inserted peripherally it is a long flexible catheter that
travels through the vein and its tip ends near the heart
where there is a high volume of blood flow.
Risks of Intravenous Therapy
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Infection – results if a product contaminated with bacteria
is infused into a patient.
- human touch contamination continues to be the most
common source of IV related contamination.
Air embolus – incidence is low, because many solutions
are administered using infusion pumps equipped with an
alarm that sound when air is in the IV line. These are
called air-in-line alarms.
- in adults it takes 150 or 200 mL of air (much less in
infants or pediatric patient) given quickly to result in
harm.
Risks continued…
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Bleeding – when the IV catheter is removed, bleeding may
occur around the catheter site.
Allergic reaction – when a patient has an allergic reaction to
a substance given parenterally the reaction is usually more
severe than if the same substance was given by another
route (e.g. mouth, topically, or rectally)
- one reason for this is that substances given parenterally
cannot be retrieved like substances given by other routes.
Incompatibilities – if an incompatibility exists, the drug
might precipitate, be inactivated, or adhere to the container.
Incompatible solutions should not be administered to
patients.
Risks continued…
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Extravasation – occurs when the catheter punctures and
exits the vein under the skin, causing drugs to infuse or
infiltrate into the tissue.
Particulate matter – refers to particles present in
parenteral products. When injected into the bloodstream
can cause adverse effects to the patient. Examples:
- microscopic glass fragments
- hair
- lint or cotton fibers
- cardboard fragments
- undissolved drug particles
- fragments of rubber stoppers
Risks continued…
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Pyrogens – the by-products or remnants of bacteria, can
cause reactions (e.g. fever and chills) if injected in large
enough amounts.
Phlebitis – Irritation of the vein. Caused by:
- the drug being administered (due to it chemical properties
or its concentration)
- the location of the IV site
- a fast rate of administration
- the presence of particulate matter
- the patient usually feels pain or discomfort along the path
of the vein (often severe) and red streaking may also
occur
Aseptic Preparation of Parenteral
Products

Aseptic Technique
- Programs designed to ensure the aseptic preparation of
sterile products.
- The main elements these programs focus on are:
1. the development and maintenance of good aseptic
technique in the personnel who prepare and
administer sterile products.
2. Development and maintenance of a sterile
compounding are complete with sterilized equipment
and supplies.
3. Development and maintenance of the skills needed to
properly use a laminar flood hood (LAH).
Aseptic Technique continued…
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Aseptic technique is a means of manipulating sterile
products without contaminating them.
Proper use of a LAH and strict aseptic technique are the
most important factors in preventing the contamination of
sterile products.
Sterile Compounding Area
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Sterile parenteral solutions must be free of living
microorganisms and relatively free of particles and
pyrogens.
A sterile compounding area should be cleaned daily and
segregated from normal pharmacy operations, patient
specimens, nonessential equipment, and other materials
that produce particles. Examples:
- cardboard into the clean environment should be avoided.
- traffic flow should be minimized.
- floors should be disinfected periodically.
- trash should be removed frequently and regularly.
Compounding Area continued…
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Sterile products should be prepared in a Class 100
environment, which contains no more than 100 particles
per cubic foot that are 0.5 micron or larger in size.
LAHs are frequently used to achieve a Class 100
environment.
Laminar Airflow Hoods (LAH)

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Underlying principle of LAHs is that twice-filtered layers of aseptic
air continuously sweep the work area inside the hood to prevent
the entry of contaminated room air.
Two common types:
- Horizontal LAH – sweeps filtered air from the back of the
hood to the front.
1. use an electrical blower to draw contaminated room
air through a prefilter.
2. The prefilter, which is similar to a furnace filter, only
removes gross contaminants and needs to be cleaned
or replaced on a regular basis.
3. The high efficiency particulate air or (HEPA) filter
removes 99.9% of particles that are 0.3 micron or
larger.
Laminar Airflow Hoods continued…
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Vertical LAH – HEPA filtered air emerges from the top and
passes downward through the work area.
- used for antineoplastic (anticancer) drugs.
- the risk of exposure to airborne drug particulates is
minimized.
- the type of vertical LAH used for the preparation of
antioneoplastics contains airflow within the hood and are
referred to as biological safety cabinets (BSCs).
The critical principle of using LAHs is that nothing interrupts
the flow of air between the HEPA filter and the sterile object.
The space between the HEPA filter and the sterile object is
known as the critical area.
Hoods continued…
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To maintain sterility, nothing should pass behind a sterile
object in a horizontal flow hood or above a sterile object in
a vertical flow hood.
Materials placed within the laminar flow hood disturb the
patterned flow of air blowing from the HEPA filter. This
“zone of turbulence” created behind an object could
potentially extend outside the hood pulling or allowing
contaminated room air into the aseptic working area.
It is advisable to work with objects at least six inches
from the sides and front edge of the hood without blocking
air vents, so that unobstructed airflow is maintained
between the HEPA filter and sterile objects.
Hoods continued…
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The following are general principles for operating LAHs
properly:
- A LAH should be positioned away from excess traffic,
doors, air vents, or anything that could produce air currents.
- If turned off, it should be allowed to run for 15-30 minutes
before use.
- Before use, all interior working surfaces of the laminar
flow hood should be cleaned with 70% isopropyl alcohol or
other appropriated disinfecting agent and a clean, lint-free
cloth. Cleaning should be performed from the HEPA filter
toward the front of the LAH (in a horizontal LAH) so that
contaminants are moved out of the hood.
Hood Criteria continued…
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Nothing should be permitted to come in contact with the
HEPA filter. This includes cleaning solution, aspirate from
syringes, or glass from ampules. Ampules should not be
opened directly toward the filter.
Do not put paper, pens, labels, or trays into the hood.
Jewelry should not be worn on the hands or wrists when
working in the LAH since it may introduce bacteria or
particles into the clean work area.
Actions such as talking and coughing should be directed
away from the LAH working area, and any unnecessary
motion within the hood should be avoided to minimize the
turbulence of air flow.
Hood Criteria continued…
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Smoking, eating or drinking are prohibited in the aseptic
environment.
All aseptic manipulations should be performed at least six
inches within the hood to prevent the possibility of
potential contamination caused by the closeness of the
worker’s body and backwash contamination resulting from
turbulent air patterns developing where LAH air meets
room air.
LAHs should be tested by qualified personnel every six
months, whenever the hood is moved, or if filter damage
is suspected.
Personal Attire
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The first component of good aseptic technique is proper
personal attire.
Clean garments, which are relatively particulate free,
should be worn when preparing sterile products.
Many facilities provide clean scrub suits or gowns for this
purpose.
Hair covers and shoe covers help reduce particulate or
bacterial contamination, and some experts claim that the
use of surgical masks and gloves is warranted as well.
USP 797 – New Standards

The primary structure of the new USP standards is based
on 3 risk levels classified according to the potential for:
- Microbial contamination
(microorganisms and endotoxins)
- Physical contamination
(particulate contaminants: from cotton garments,
cardboard cartons, pencils, paper towels, chewing gum
and electronic equipment)
- Chemical contamination
(solid or liquid matter from precipitates)
Standards continued…
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There are specific standards for each risk level.
Standards regarding personnel training, environmental
quality and control, verification of compounding accuracy,
packing and transport, adverse event reporting, storage,
and beyond-use dating.
Risk Levels: Low Risk

Definition:
- All aseptic manipulations
within class 100
environment using only
sterile ingredients and
devices
- Only single transfers
used
- Measuring/mixing no more
than 3 products

Examples:
- Single patient doses
- Single patient syringe w/o
additives
- Batch syringes with
preservatives
- Sterile solution withdrawn
from an amp and filtered to
remove glass particles
- Manually prepared TPN
with three ingredients
Risk Levels: Medium Risk

Definition:
- No Broad Spectrum
antibacterial present
despite administration over
several days
- Complex aseptic
manipulations
- Multiple doses in one
container for multiple
patients or one patient on
multiple occasions

Examples:
- Batch reconstituted
antibiotics without
preservatives
- Batch syringes w/o
preservative
- Filling reservoirs with
multiple sterile products and
evacuating air for
administration over several
days at room temperature
- TPN prepared by a
compounder
Risk Levels: High Risk—requires
certification test

Definition:
- Sterile products
compounded from
nonsterile ingredients or
use of a nonsterile device
prior to terminal
sterilization
- Sterile ingredients,
components, or devices
exposed to air quality <
class 100 if opened or
partially used and not
adequately preserved

Examples:
- Mixing or measuring in
nonsterile devices
- Assuming 95% purity of
ingredients
- Injections made from
nonsterile powder that will
be terminally sterilized
- Compounded bladder
irrigations
- TPN for terminal sterilization
by final filtration
Environmental Quality Control

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Work bench area: where compounding is completed
Buffer area = clean room: area immediately surrounding
the work bench. Should not contain any drains or sinks.
Ante area: Space beyond the buffer area where hand
sanitizing and gowning occurs.
- includes hands free faucets and air dryers or low-shedding
towels.
- Supplies are unpacked and disinfected for storage in the
ante room.
Environmental Quality Control

General Requirements:
- Must limit tasks performed in the buffer area to those
directly related to compounding.
- 2 stainless steel carts with cleanable castors;
1. one for buffer area
2. collecting medications solutions and supplies that
are cleaned and sanitized before being transferred
to the buffer cart for compounding.
Environmental Quality and Control
Compounding personnel must be properly garbed in clean
room
FYI: A motionless person sheds 100,000 particles every 60
seconds…Skin flakes, hair, salt, oils, moisture droplets,
even deodorant.
For all risk levels:
Hair covers, shoe covers, knee-length coats or coveralls with
Snug wrist and front closures face masks, and gloves
Training and Performance
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Documentation for Tech training
Prior to commencing any compounding, perform a
thorough didactic instruction in the theory and practice of
sterile preparations, with evaluation of technique
- annually for low and medium risk levels
- semiannually for high risk levels
Compounder evaluations should include a formal written
exam and practical evaluation of aseptic technique using
growth media
Handwashing
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Touching sterile products while compounding is the most
common source of contamination of pharmacy prepared
sterile products.
Scrub your hands, nails, wrists, and forearms thoroughly
for at least 30 seconds with a brush, warm water, and
appropriate bactericidal soap before performing aseptic
manipulations. Wash your hands frequently and every
time you re-enter the sterile compounding area.
Workers who have open sores on their hands or have an
upper respiratory tract infection should inform their
supervisor and/or consult the institutions quality assurance
procedures. Wear sterile gloves and mask is needed.
Equipment and Supplies

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Another important factor in aseptic preparation of sterile
products is the correct use of appropriate sterile
equipment and supplies, including syringes and needles.
Syringes:
- made of either glass or plastic
- most drugs are more stable in glass, so glass syringes
are most often used when medication is to be stored in
the syringe for an extended period of time.
- Composed of a barrel and plunger. To maintain sterility
of the product, do not touch the syringe tip or plunger.
Many syringes have a locking mechanism at the tip:
Leur-lock, which secures the needle within a threaded
ring.
Syringes continued…
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Available in numerous sizes ranging from 0.5 to 60 mL.
Usually the larger the syringe capacity, the larger the
interval between calibration lines.
Ideally, the volume of solution should only take up ½ to
2/3 of the syringe capacity. This avoids inadvertent touch
contamination caused when the syringe plunger is pulled
all the way back.
When measuring with a syringe, lineup the final edge
(closest to the tip of the syringe) of the plunger piston,
which comes in contact with the syringe barrel, to the
calibration mark on the barrel which corresponds to the
volume desired.
Syringes continued…
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The syringe package should be opened within the laminar
flow hood in order to maintain sterility.
The wrapper should be peeled apart and not ripped or
torn.
To minimize particulate contamination, do not lay
discarded packaging on the LAH work surface.
The syringe tip protector should be left in place until it is
time to attach the needle.
Needles

Sizes are described by two numbers:
- Gauge: corresponds to the diameter of its bore, which is
the diameter of the inside of the shaft. The larger the
gauge the smaller the needle bore.
Ex: the smallest needles have a gauge of 27, the
largest needles have a gauge of 13.
- Length: the needle shaft is measured in inches and
usually ranges from 3/8 to 3 ½ inches.
Needles continued…
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Components of a simple needle:
- Hub: attached the needle to the syringe and is often
color-coded to correspond to a specific gauge.
- Shaft: the tip of the needle shaft is slanted to form a
point. The slant is called the bevel, the point is called the
bevel tip. The opposite end of the slant is termed the
bevel heel.

No part of the needle itself should be touched. Needles
should be manipulated by their over-wrap and protective
covers only. The protective cover should be left in place
until the needle and/or syringe are ready to be used.
Needles continued…

A needle shaft is usually metal and is lubricated with a
sterile silicone coating.
- For this reason, needles should never be swabbed with
alcohol.

Some needles have built in filters and are meant to be
used with products requiring frequent such as drugs
removed from a glass ampule.
Drug Additive Containers

Ampules
- Composed entirely of glass and once broken (opened)
become open-system containers
- Since air or fluid may now pass freely in and out of the
container, it is not necessary to replace the volume or
fluid to be withdrawn with air.
- Before an ampule is opened, any solution visible in the
top portion (head) should be moved to the bottom (body)
by swirling the ampule in an upright position, tapping the
ampule with your finger or inverting the ampule and then
quickly swinging it into an upright position.
Ampule continued…
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To break an ampule properly, the head must be broken
from the body of the ampule. To make the break properly,
the ampule neck is cleansed with an alcohol swab and the
swab should be left in place.
To withdraw medication from an ampule, the ampule should
be tilted and the bevel of the needle placed in the corner
space (or shoulder) near the opening.
To withdraw the solution, use a filter needle and change to
a regular needle BEFORE expelling the contents.
the filter needle must not be used for both withdrawing
from the ampule and expelling from the syringe, because
doing so would nullify the filtering effort.
Ampules continued…
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Usually the medication is withdrawn
from the ampule with a regular
needle and then the needle is
changed to a filter needle before
pushing drug out of the syringe.
Vials
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Is a glass or plastic container with a rubber stopper
secured to its top, usually by an aluminum cover.
They are used to hold powders and liquids.
The rubber stopper is usually protected by a flip-top cap or
aluminum cover.
Most protective covers do not guarantee sterility of the
rubber stopper; therefore, before the stopper is
penetrated, it must be swabbed with 70% isopropyl
alcohol and allowed to dry.
Vials continued…
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Swabbing helps achieve sterility in two ways:
- the alcohol acts as a disinfecting agent
- the physical act of swabbing in one direction removes
particles.
When piercing vials with needles, avoid coring fragments
out of the rubber stopper with the needle.
- a core is carved out of the rubber stopper when the
bevel tip and the bevel heel do not penetrate the stopper
at the same point.
Vials are closed-system containers since air or fluid
cannot pass freely in or out of them.
Vials continued…
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In most cases, air pressure inside the vial is similar to that
of room air.
In order to prevent the formation of a vacuum inside the
vial (less pressure inside the vial than room air) the user
should normalize pressure by first injecting into the vial a
volume of air equal to the volume of fluid that is going to
be withdrawn.
If the drug is in powdered form, it has to be reconstituted.
Inject the desired volume of sterile diluting solution (the
diluent), such as sterile water for injection, into the vial
containing the powdered drug.
Vials continued…
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An equal volume of air must be removed in order to
prevent a positive pressure from developing inside the
vial.
Vials with drugs in solution are classified as multipledose (also called multiple use) or single-dose.
Multiple-dose vials contain a small amount of a
preservative agent, added to retard the growth of bacteria
or other organisms that inadvertently contaminate a
product.
Single-dose vials have no preservative and are intended to
be used one time only. Once a vial is entered with a
needle, it should be discarded.
Pre-filled Syringes
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Drugs commonly given IM or IV are packaged this way to
make them convenient for the health care provider.
It is also done if the drug is commonly used in emergency
situations because a pre-filled syringe saves time.
Preparation of Intravenous Admixtures
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Before compounding – assemble all materials and visually
inspect vials, ampules, and IV solution containers for signs
of cloudiness, particulate matter, cracks and punctures,
expiration dates, and anything else that may indicate that
the product is defective.
Preparation continued…
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Next, disinfect all injection surfaces and allow them to dry.
- Flexible plastic bag – made of polyvinyl chloride (PVC)
are frequently used.
- Easier to store, less breakable than glass bottles, and
eliminates the need to vent the container when
removing fluid.
- The protective overwrap should not be removed from
a PVC bag until it is ready to be used.
- To minimize air turbulence in the critical area, position
the injection port of a PVC bag, which is covered by an
outside latex tip diaphragm, toward the HEPA filter
when preparing an IV admixture.
Disposal of Supplies
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Syringes and uncapped needles should be discarded
according to institutional policy.
Never recap a needle. Lay the syringe horizontally and
slide the cap onto the needle. Or place the syringe
vertically and drop the cap onto the needle.
In some institutions supplies are discarded in punctureresistant, sealable containers often called sharps
containers.
Labeling

Properly label the IV with the following information:
- Patient name, ID number and room number (if inpatient)
- Bottle or bag sequence number, when appropriate
- Name and amount of drugs(s) added
- Name and volume of admixture solution- Auxiliary labeling
- Approximate final total volume of the admixture, when
applicable
- Prescribed flow rate (in mLs per hour)
- Date and time of scheduled administration
- Date and time of preparation
- Expiration date
- Initials of person who prepared and person who checked
the IV admixture
- Auxiliary labeling – supplemental instructions and precautions
- Typically drugs are considered stable as long as they are
within 10% of their labeled potency.
Administration Systems for Parenteral
Products
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Continuous Infusions
- More effective and less toxic than when given
intermittently.
- Includes:
1. Basic fluid and electrolyte therapy
2. Blood products
3. Specific drugs that require tight administration
control to minimize adverse effects
Parenteral Systems continued…
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Intermittent Injections
- Used to administer medications that work better when
infused at defined time intervals rather than when infused
continuously.
- Examples of drugs commonly given intermittently are:
1. antibiotics
2. drugs used to treat or prevent gastrointestinal
ulcers
Intermittent Injections continued…
- Types of systems for intermittent injections:
1. Large Volume Parenterals (PVC)
a. Usually defined as those IV solutions containing
more than 100 mL
b. Usually infused as solutions of dilute dextrose
and/or sodium chloride as continuous infusions
with or without additives, but they can be used
for intermittent infusions as well.
- Commercially Available
1. Preparations with additives are used in standard
concentrations, are stable in solution for long periods of
time.
2. Available in a variety of sizes and containers
3. Ready-to-use products are advantageous because they reduce
handling by the pharmacy, - the potential for contamination.
Intermittent Injections continued…
- Pharmacy Prepared
1. Made in the pharmacy to meet the specific needs of
patients
2. Prepared in different volumes and different containers
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Syringe Systems
- Most common drug delivery systems that use syringes are:
1. syringe pumps
2. volume control chambers
3. gravity feed
4. intravenous push systems
- Require that the pharmacy fill syringes with drugs and label them.
- Stability may differ from the stability of the same drug in other
dosage forms because of concentration differences.
Intermittent Injections continued…
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Syringe Pumps
1. Used to administer drugs by means of a specially
designed syringe pump and tubing set.
2. Pumps are either operated by a battery or a
compressing spring.
3. Pumps are also available to administer a single dose
per setup or a 12 or 24 hour supply at preprogrammed
intervals.
Volume Control Chambers (Buretrol or Volutrol)
1. The drug is injected through a port on top of the
chamber, and solution is added from the primary LVP.
2. With this system, minimal amounts of fluid can be given per
dose, a method that may be beneficial in fluid-restricted or
pediatric patients.
Intermittent Injections continued…
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Gravity Feed
1. Tubing set has an air vent through which air enters
the syringe as fluid is pulled out by gravity.
2. The system is relatively inexpensive and requires no
other special equipment.
Intravenous Push
1. Drugs given by IV push are injected directly into the
IV tubing and pushed into the patient quickly.
2. Injected into an injection port, a Y-site on the IV tubing,
or an injection flashball.
3. Disadvantage – difficult to control the rate of drug
delivery with a syringe and many drugs cause the
patient to experience adverse effects when given too
quickly.
Intermittent Injections continued…
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Small Volume Parenterals (“Piggyback” Systems)
1. Common method for drug additives to a small
volume parenteral or piggyback (< 100 mL)
2. The piggyback is placed higher than the primary IV
(usually an LVP) so that gravity causes the drug
solution to run into the patient’s vein before the
primary fluid.
3. The back-check valve at the proximal Y-site closes
off while the piggyback is being administered, thus
preventing the piggyback solution from entering the
primary IV.
Intermittent Injections continued…
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Add-Vantage – specially designed bag and a vial
Vial Spike System – similar in concept to the Add-Vantage
system – not activated until just before administration.
Premixed Solutions – often frozen and thawed by the
pharmacy hours or days before administration.
Bags/bottles containing powder for reconstitution –
requires to be added to a bottle of 20 to 100 mL of
solution – piggyback system
Controlled-release infusion system (CRIS) – delivers
medication directly form the vial to the primary IV
solution.
Patient Controlled Analgesia (PCA)
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A method of drug administration usually used with
injectable pain medications, which is very effective in
managing pain.
Two advantages of PCAs:
- they eliminate the need for painful IM injections
- reduce patients’ anxiety about controlling their pain
Goals of PCA – to relieve pain as soon as the patient
recognizes a need for it.
- may also reduce nursing time associated with pain
medication administration.
PCA continued…
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Used with either a stationary or a portable pump.
The pump releases a programmed amount of the pain
medication into the IV tubing when the patient pushes a
button.
The pump is programmed to release an amount of pain
medication that is specific for the patient’s weight and
condition.
The pump is also programmed to limit how often the
patient may push the button and receive pain medication.
PCA continued…
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The pump may be programmed to allow a patient to
receive a maximum of 1 mg of drug every 15 minutes.
When the patient pushed the button, the pump injects 1
mg. If the patient pushes the button again in 10 minutes,
the pump does not release the drug. If the patient pushes
the button at least 5 minutes later (15 minutes since the
last injection), the pump again administers 1 mg. This is
often referred to as a 15-minute lock-out period.
Differs from most other products in two ways:
- if the patient does not have other means of pain control,
there might be an urgency to initiate therapy.
- these doses usually contain enough medication to last at
least 8 hours and often up to 24 hours or more.
Total Parenteral Nutrition Solutions
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Definition:
- Total parenteral nutrition (also known as hyperalimentation,
hyperal or TPN) is the IV administration of nutrients needed
to sustain life: carbohydrates, protein, fats, water,
electrolytes, vitamins, and trace elements.
- Usually initiated in patients who cannot meet their
nutritional needs from other sources for an extended period
of time.
- TPN is used for patients who cannot eat (e.g. head & neck surgery,
comatose, or before or after surgery), who will not eat (e.g.
patients with esophageal obstruction or inflammatory bowel
disease or who cannot eat enough (e.g. patients with cancer,
burns or trauma).
Components of Parenteral Nutrition
Solutions
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Contain base components and additives
- Base components are usually mixed first and make up
much of the volume of the TPN. Composed of dextrose
(carbohydrates) and amino acids (protein) and may
include fat and water.
- Additives are usually mixed with the base components
and include life-sustaining nutrients, electrolytes, vitamins,
trace elements as well as heparin, insulin and H2
antagonists.
Additives continued…
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Carbohydrates – usually administered in the form of
dextrose because of its low cost and easy availability.
Usually a 50 – 70% solution is used in TPN preparation,
and the final dextrose concentration in the TPN is usually
around 25% for solutions administered via central vein.
Protein – required for tissue synthesis and repair,
transport of body nutrients and waste, and maintenance of
immune function. These solutions are available in
concentrated form, such as 8.5 – 10% and diluted in the
compounding process.
TPN continued…
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Fats – (lipids) are usually administered as fat emulsions.
Administered as a source of calories. Available as 10 to
20% emulsions dispensed in a separate container given
through a peripheral IV line. Fats can be added to the TPN
solution (3-in-1 solution or total nutrient admixture).
Considered a third base component along with dextrose
and amino acids.
Water – in all preparations and is usually derived from the
components used in the preparation. The purpose of
adding water is to offset normal bodily losses and prevent
dehydration.
TPN continued…
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Electrolytes – needed to meet daily metabolic needs and
correct deficiencies. Usually include sodium, potassium,
chloride, acetate, phosphate, magnesium, and calcium.
Vitamins – usually administered in a standard formulation
o fat and water-soluble vitamins and are often abbreviated
as “MVI.” When vitamin K (phytonadione) is needed it is
usually given separately as an IM injection.
Trace elements – required for proper enzymatic reations
and for use of energy sources in the body. Typical
elements administered are copper, zinc. Chromium,
manganese, selenium and iron.
TPN continued…
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The proper order of mixing is:
- add the fats first (adding concentrated dextrose may “oil
out” or crack the emulsion)
- the amino acid second
- the dextrose last
- remember the acronym “FAD” fats, amino acids, dextrose
- this mixing order dilutes and buffers the fat emulsion with
amino acids before the highly concentrated and acidic
dextrose is added.
Automated Compounding
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Three primary pieces of equipment are used, sometimes
together and sometimes individually.
- An automated compounder prepares the base components
dextrose, amino acids, and possibly fat emulsion & H20
- A second automated compounder adds most or all of the
additives or other components
- A computer with software maintains the orders of the
ingredients and controls the two compounders.
Compounding continued…
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The base compounder accounts for the specific gravity of
the solutions being used and actually weighs the amount
pumped into the final container.
The additives compounder weights the solution to ensure
proper volumes and flushes the line between injections to
avoid incompatibility problems. The additives compounder
must be used with the computer and cannot be
programmed alone.
Administration
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Most TPN solutions are made for administration through a
central line.
This route is used because it results in immediate dilution
of the solution being administered and therefore a very
concentrated solution can be administered.
Administering a concentrated solution often allows the
medical team to completely meet an adult patient’s daily
nutritional needs with 2000 to 3000 mL of TPN solution.
Occasionally, TPNs are administered through a peripheral
IV line – can contain same ingredient, but diluted to a
lower osmolarity. Since the solution is more dilute, they do
not meet al the patient’s nutritional needs. May need
supplements for caloric intake.
Pediatric Parenteral Drug
Administration
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Standardization of doses is not as common in pediatric
patients as it is in adults.
Their doses are usually calculated based on their body
weight, resulting in much smaller dose than most adults
receive.
The volume of solution also is limited since their blood
volume is considerably less than that of an adult.
Intermittent doses are usually given by syringe through a
volume control chamber or by using a syringe pump.
Quality Assurance Program
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
The ASHP technical assistance bulletin describes three
different levels of risk for products.
Products are classified into one of the three risk levels
based on:
- How they are prepared
- How long they can be stored
- whether they are prepared for a single patient or as part
of a batch, whether they are from a sterile or non-sterile
source.
Characteristics of Risk Levels

Risk Level 1
- Sterile products w/o preservatives for individual patients
or batch prepared with preservatives for multiple patients.
- These are sterile products transferred into a sterile
container (e.g. syringe, IV bag or bottle).
- Storage time for these products, including administration
time, should not exceed 28 hours at room temperature,
7 days under refrigeration, or 30 days if frozen.
Characteristics continued…
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Risk Level II
- These products are batch-prepared w/o preservatives for
multiple patients.
- These include products that require multiple sterile ingredients
that are combined in a sterile container through a closed system
transfer that are then subdivided into multiple parts.
Hyperalimenation over a week
- Storage time for these products, including administration time,
can exceed 28 hours at room temperature, 7 days under
refrigeration, or 30 day frozen.
Characteristics continued…
Risk Level III
- These products are compounded from nonsterile
ingredients, containers or equipment or prepared from
sterile or nonsterile ingredients in an open system.
intrathecal pump meds.
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The pharmacist is likely to be responsible for ensuring
compliance with the guidelines and other standards of
practice.
Areas of the document that affect the technician include
training, policies and procedures, garb, aseptic technique,
process validation, and end-product evaluation.
Process Validation
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Means procedures that ensure that the processes used in
sterile product preparation consistently result in sterile
products of acceptable quality.
For most aseptic processes, validation is actually a method
for evaluating the aseptic technique of personnel.
Validation may be accomplished through process
simulation.
Process simulation is carried out just like a normal sterile
product preparation process except that a microbial
growth medium is substituted fro the products that would
normally be used.
Process Validation continued…
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Once the sterile product is prepared, the growth medium
is incubated and evaluated for microbial growth over a
period of time.
No microbial growth indicates that the person performing
the preparation did not contaminated the product.
Individuals should complete a process validation program
before being allowed to prepare sterile products, and
technique should be re-evaluated regularly.
End-Product Evaluation
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End-product evaluation is the final inspection made by the
pharmacist before the product is allowed to leave the
pharmacy.
It includes an inspection for leaks, cloudiness, particulate
matter, color, solution volume, and container integrity.
The pharmacist also verifies compounding accuracy with
respect to the correct ingredients and quantities.
This check of the technician’s work is an important step in
ensuring that only quality products are sent for patient
use.