3. Topics3
Learning Objectives
Gain an awareness of the history of ampules.
Understand the identifying characteristics of ampules and their
purpose in sterile compounding procedures.
Identify the USP Chapter <797> procedures that must be
performed during the compounding of ampule-based
preparations.
Demonstrate excellent aseptic technique in the compounding
of ampule-based preparations.
Recognize the safety issues associated with the opening of
ampules.
2012 Paradigm Publishing
4. Topics4
Topics
Learning Objectives
Introduction
Opening of Ampules
Contents of Ampules
Administration of Ampule-Based Preparations
Properties of Ampule Medications
Risks of Parenteral Preparations
USP Chapter <797> Guidelines for Ampule-
Based Preparations
Understand the Resources and Supplies
Preview the Lab Procedure
Chapter Summary
2012 Paradigm Publishing
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5. Topics55
Introduction
Ampules are made from
thin, medical-grade glass
tubing and are
manufactured as sterile
containers for specific
medications, many of which
are incompatible with the
rubber or PVC components
found in most vials
2012 Paradigm Publishing
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Opening of Ampules
An ampule is designed so
that the neck is either
scored or made of
thinner glass, called a
break ring
an IV technician applies
pressure to either the
scored area or the break
ring of the tapered neck,
which breaks off the head
of the ampule
2012 Paradigm Publishing
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Opening of Ampules…/2
Once the ampule is opened, and prior to injecting
the medication into the compounded sterile
preparation (CSP), the solution must be filtered by
passing it through a single-direction filter needle
this specialty needle removes any minute glass fragments
that may have fallen into the ampule’s fluid during the
opening process
2012 Paradigm Publishing
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Contents of Ampules
Ampules most often contain sterile medications,
such as promethazine or epinephrine, for parenteral
administration
occasionally, ampules contain a sterile powdered
medication that requires the IV technician to reconstitute
the powder with a sterile diluent prior to drawing it up into
a syringe for parenteral administration
2012 Paradigm Publishing
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Contents of Ampules…/2
In general, ampule medications range in volume from
as little as 1 mL to as much as 20 mL
the fragile nature of the glass ampule renders it incapable
of safely storing larger fluid volumes
for the most part, the medication contained within a single
ampule is sufficient to provide the necessary dose for a
single intravenous piggyback (IVPB) or IV drip
2012 Paradigm Publishing
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Administration of Ampule-Based
Preparations
Ampule-based preparations may be administered by
intramuscular (IM) injection or, more often,
intravenously
administered by piggybacking them through IV tubing
attached to a primary IV solution, or through a
heparin lock
the pharmacy must consider the physical and chemical
properties of ampule medications, including compatibility
and stability, when determining the appropriate IVPB base
solution and volume
2012 Paradigm Publishing
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Properties of Ampule Medications
The physical and chemical properties of ampule
medications vary widely
some ampule medications have an acidic pH value, a
higher osmotic pressure, or a higher tonicity
however, as is the case with vial medications, once the
ampule medication is injected into an IVPB base solution,
the resulting CSP has physical and chemical properties that
are generally isotonic, isoosmotic, and pH neutral
2012 Paradigm Publishing
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Properties of Ampule
Medications…/2
In some circumstances, a parenteral medication that
is neutral despite being diluted in an IVPB base
solution will be administered over a long period to
avoid any and all potential problems related to
phlebitis or other administration risks
for instance, the medication gentamicin, which is generally
isotonic and pH neutral, is administered by IVPB over a
period of at least 60 minutes to avoid potential problems
due to ototoxicity or nephrotoxicity, which may result
from rapid administration of the medication
2012 Paradigm Publishing
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Risks of Parenteral Preparations
Preparation Risks
A preparation risk unique
to ampule-based
preparations is the
presence of broken glass
during the opening of an
ampule
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Risks of Parenteral
Preparations…/2
Preparation Risks…continued
Broken glass can create a hazardous situation for
both the patient and the IV technician
during the breaking process, minute shards of glass are
commonly deposited in the contents of the ampule
all ampule medications must be passed through a filter
needle so that glass particles do not transfer into the CSP
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Risks of Parenteral
Preparations…/4
Administration Risks
All patients receiving parenteral fluids should be
monitored for the following complications:
nosocomial infection
allergic reaction (including anaphylaxis)
phlebitis
tissuing
embolism
extravasation
cellulitis
Stevens-Johnson syndrome
nephrotoxicity
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Risks of Parenteral
Preparations…/5
Administration Risks…continued
CSPs prepared from ampules have similar
preparation and administration risks as those
prepared from vials
as is the case with all CSPs, the most common risks
associated with ampule medications include phlebitis,
allergic reaction, nosocomial infection, and medication-
specific side effects, such as GI upset or drowsiness
2012 Paradigm Publishing
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USP Chapter <797> Guidelines for
Ampule-Based Preparations
During preparatory and compounding procedures of
ampules, the IV technician must adhere to the
overarching principles set forth in USP Chapter <797>
these guidelines are reinforced in each facility’s P&P
manual
in accordance with these guidelines, sterile compounding
personnel must pay strict attention to aseptic technique
protocol both in the anteroom and clean room
2012 Paradigm Publishing
19. Topics19
Your Turn
2012 Paradigm Publishing
1) An ampule is designed so that the neck is either scored or made of
thinner glass, called a
a. back tube.
b. break tube.
c. back ring.
d. break ring.
2) This specialty needle removes any minute glass fragments that may
have fallen into the ampule’s fluid.
a. regular
b. vented
c. filter
d. sheath
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20. Topics2020
Understand the Resources and
Supplies
Essential Supplies
The vast majority of sterile compounding procedures
require the same essential supply items to be
available for use in both the anteroom and the
clean room
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Understand the Resources and
Supplies…/2
Procedure-Specific Supplies
Ampule
the base of the ampule, called the ampule body, is the
largest portion of the ampule, and it is the area that
contains the sterile fluid
the uppermost part of the ampule body, just before it
starts to narrow, is sometimes referred to as the ampule
shoulder
the narrowest portion of the ampule is the ampule neck,
which must be broken in order to access the fluid within
2012 Paradigm Publishing
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Understand the Resources and
Supplies…/3
Procedure-Specific Supplies
Ampule…continued
the ampule head is the small
glass bulb located above
the neck
once the neck has been broken
and the ampule head removed,
the ampule is then considered
to be an open container and
should, therefore, be treated as
a single-use container
2012 Paradigm Publishing
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Understand the Resources and
Supplies…/4
Procedure-Specific Supplies
Ampule…continued
there are a number of methods that IV technicians use to
open an ampule safely
while employing these methods may seem to provide a
certain degree of protection to the worker, these
techniques may create more problems than they solve
some IV technicians slip small plastic caps called ampule
breakers over the heads of the ampules to safely
open them
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Understand the Resources and
Supplies…/5
Procedure-Specific Supplies
Ampule…continued
many IV technicians prefer
to simply open an ampule
with their gloved hands
provided the ampule is
opened using proper
aseptic technique, this
method is safe, efficient,
and cost effective
2012 Paradigm Publishing
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Understand the Resources and
Supplies…/6
Procedure-Specific Supplies
Filter Needle and Filter
Straw
there are a number of
different filters—including
filter needles, filter
straws, and filter discs—
that may be used during
sterile compounding
procedures
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Understand the Resources and
Supplies…/7
Procedure-Specific Supplies
Filter Needle and Filter Straw…continued
when working with ampules, the type of filter most
commonly used is a 5-micron filter needle
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Understand the Resources and
Supplies…/8
Procedure-Specific Supplies
Filter Needle and Filter Straw…continued
when withdrawing a large amount of fluid (a volume
greater than 5 mL) from an ampule, some IV technicians
use a single-direction filter straw
this sterile, hollow, plastic tube attaches to a syringe and
contains a 5-micron filter
as the IV technician withdraws fluid from the ampule
through the filter straw into a syringe, glass shards are
trapped in the filter
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Understand the Resources and
Supplies…/9
Procedure-Specific Supplies
Filter Needle and Filter Straw…continued
a filter needle is always used in conjunction with a regular
(nonfilter) needle when compounding ampule-based
preparations
the choice of whether to first use the regular needle to
withdraw the fluid from the ampule and then use the filter
needle to inject the fluid from the syringe into the IVPB—
or vice-versa—is dependent upon the viscosity of the fluid
within the ampule and the directives set forth within a
facility’s P&P manual
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Understand the Resources and
Supplies…/10
Procedure-Specific Supplies
IVPB Base Solution
for ampule-based preparations,
the IV technician uses an IVPB
base solution bag with a tail
injection port
2012 Paradigm Publishing
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Understand the Resources and
Supplies…/11
Critical Sites of Essential
Supplies and Ampules
The IV technician must
recall the critical sites
of the supplies
2012 Paradigm Publishing
31. Topics3131
Preview the Lab Procedure
Anteroom Preparatory Procedures
verifying the CSP label against the
medication order
performing correct pharmacy
calculations to determine type, size,
and number of supply items needed
gathering and cleaning of supplies
performing aseptic garbing and hand
washing
donning a sterile gown
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Preview the Lab Procedure…/2
Clean Room Preparatory
Procedures
cleansing hands with
sterile, foamed 70% IPA
donning sterile gloves
cleaning the hood
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Preview the Lab Procedure…/3
Ampule-Based Compounding
Procedure
pick up the ampule and gently
tap or swirl the container
swab the neck of the ampule
prepare the syringe
hold the body of the ampule
firmly but gently in your
nondominant hand
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Preview the Lab Procedure…/4
Ampule-Based Compounding
Procedure…continued
always snap the ampule away
from you
remove the regular needle cap
pull back on the flat knob of the
plunger with the thumb or
forefinger of your dominant
hand
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Preview the Lab Procedure…/5
Ampule-Based Compounding Procedure…continued
hold the barrel of the syringe with the capped needle
pointing upward, and tap the syringe barrel to force bubbles
up toward the syringe tip
2012 Paradigm Publishing
36. Topics36
Your Turn
2012 Paradigm Publishing
3) This is the name for the base of the ampule.
a. shoulder
b. neck
c. body
d. head
4) When withdrawing a large amount of fluid, some IV technicians use
this.
a. filter needle
b. filter tube
c. filter straw
d. filter breaker
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