EDUCATION

Self Study Guide

Understanding
Steam Sterilization

One Integrated Approach to Healthcare.

 Understanding Steam Sterilization

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Description of the Study Guide Topic
Steam sterilization is a complex process and requires a
range of expertise beyond an in-depth knowledge of the
steam sterilizer’s operating manual. Central sterile tech-
nicians and nurses must know proper cleaning, preparation
and packaging, optimal set designs, and the manufacturer’s
recommendations for loading and processing those sets. They
must also understand the function and mechanical compo-
nents of the sterilizer, the differences in various steam cycles,
and choose appropriate monitoring devices for steam ster-
ilization. With that knowledge base, an additional skill set
is necessary to provide a successful steam outcome with the
appropriate delivery of steam to the sterilizer. A failure in any
of the steps involved in the steam sterilization process could
adversely affect patient outcomes. Successful steam steriliza-
tion provides one final outcome; a medical device that is safe
for patient contact. Therefore, all operating and central sterile
personnel must become experts in understanding the steam
sterilization process.
Overall Purpose of the Study Guide
To understand the theory of steam sterilization, types of
steam sterilization cycles and recommended monitoring,
components and operation of the sterilizer, and causes
leading to sterilization failures.
Key Terms (Blue Bold Font)
To provide focus for the reader on vocabulary introduced and
used extensively throughout this study guide to help assure
that the learner understands the basic language associated
with this lesson.
Objectives
Upon completion of this study guide program, the partici-
pant should be able to:
1. Understand the importance of proper set design and
packaging selection to improve steam penetration and air
removal.
2. Understand the differences between gravity, immediate-
use, prevacuum, and steam flush pressure pulse (SFPP)
cycles.
3. Discuss the importance of good steam quality.
4. Understand the three components of effective steam ster-
ilization are: a properly constructed and functional steam
delivery system, proper sterilizer function, and properly
designed and packaged steam loads.
Understanding Steam Sterilization
Intended Audience
This study guide is a self-study program intended for use by
central sterile and other reprocessing technicians, periopera-
tive nurses, surgical technologists, nurses, infection preven-
tion nurses and other healthcare professionals interested in
this topic.
Introduction
Reprocessing technicians and perioperative nurses face chal-
lenges in steam sterilization every day. A significant difficulty
confronting technicians is the increasing complexity of
instrumentation and set design. The complexity creates even
greater challenges to effective steam penetration, air removal,
and the probability of dry sets. Technicians and nurses must
thoroughly understand not only the basic theories and prin-
ciples of steam sterilization, but the technological advances
and practices needed to sterilize complex instrumentation,
multilayered trays, new packaging material and containment
devices. The factors to be considered include:
• What is the device manufacturer’s recommendation for
the cycle type, exposure and drying time?
• Does this device require an extended steam sterilization
time?
• What is the recommendation for cycle type, exposure
and drying time for the packaging or containment device
used?
• Have the packaging accessories (tray liners, silicone mats,
tip protectors, etc.) been tested in that containment
device or packaging?
• What specific challenges does this set present to air
removal and steam penetration and what steps could be
taken to improve steam contact?
• Before purchase of this instrument/set/containment de-
vice did the manufacturer perform product quality assur-
ance testing to verify the efficacy of the steam sterilization
process and the avoidance of wet packs?
• Did the device manufacturer of the container or vendor
set provide instructions for the most difficult areas in the
set for steam penetration for placement of BI’s and CI’s
for product testing and routine monitoring?
Effective steam sterilization requires proper preparation and
packaging, correct selection of cycle type, exposure and dry
time, correct loading and unloading of the sterilizer, proper
maintenance of the sterilizer equipment and proper con-
struction and the maintenance of the steam delivery system
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 Understanding Steam Sterilization
including boilers, piping and traps. Other important factors
that contribute to obtaining successful steam sterilization
results include:
• Even distribution and placement of instruments (single
layer, disassemble and open hinged instruments) in the
set to promote steam contact.
• Selection of trays, liners and packaging materials that
promote the penetration of steam and air removal from
the set.
• Selection of materials in the set and containment devices
that promote faster dry times and avoidance of mixed
materials.
• Sufficient space for steam circulation and correct place-
ment of the sets on the loading carriage.
• Proper maintenance of sterilizer equipment with operator
checklist based on operator manual to audit compliance.
• Proper maintenance of the steam delivery system to
include boiler checks of sight glass, periodic blow down,
and feed water treatment, consistent steam pressure,
seasonal trap operation and cleaning of drip legs using an
operator checklist with audits to monitor compliance.
The steam sterilization process continues to evolve with
updated technology to meet the demands of complex instru-
mentation and containment devices. Cycles and sterilizer
designs introduced to meet the challenges of the late 70’s and
early 80’s may no longer be sufficient to meet the demands of
new set designs. In addition, the AAMI standard that steam
sterilizer manufacturers follow (AAMI ST8) has changed
and as a result, steam sterilization process control has become
more strict. Temperature must be controlled within a very
narrow range to help ensure consistent processing and proper
biological indicator function.
Your grandmother’s sterilizer may still sterilize older sets,
but newer sterilizer designs and packaging requires careful
inspection of the entire steam delivery system and evalua-
tion of current technique. Maintenance and/or upgrades
of the steam system may be necessary to ensure the level of
steam quality recommended by AAMI. Prep and pack and/
or loading technique may need to be adjusted to decrease the
probability of wet packs.
As advancement in technology and instrumentation contin-
ues, the need for formalized education and training programs
has increased, along with the need for traditional on site job
training. Recommended practices and standards have evolved
and are being updated regularly (for example, in the USA,
3
the guideline ANSI/AAMI ST79: Comprehensive guide to
steam sterilization and sterility assurance in health care facilities
is amended or revised every year).
Basic Principles of Steam Sterilization
This overview begins with understanding the theory and
principles of steam sterilization. Steam sterilization theory
has not changed radically, since its inception in 1880. Steam
sterilization is accomplished by using moist heat in the form
of saturated steam under pressure and remains a safe and
practical method of killing microorganisms. Rapid heating
and steam penetration with the associated brief exposure
times remains a great advantage over alternative forms of
sterilization. When installed correctly, steam sterilization can
offer an affordable cost per cycle and is generally regarded as
safe for patients and healthcare workers.
Pressurized steam is the sterilant provided to the steril-
izer chamber. When steam comes into contact with a cool
surface, it condenses (or forms water) on the item. The
thermal energy is transferred from the steam and coagulates
the cell protein to kill the microorganisms. As the steam
condenses, the reduction in steam volume draws additional
steam inside the pack increasing the efficacy of microbial
destruction. Condensed steam also revaporizes as the load
heats up. Steam must come into contact with all surfaces
in order to ensure sterilization. Air remains the greatest
enemy to steam sterilization. Air prevents steam contact with
various parts of the device/load, which can mean that it may
not be completely sterilized. The presence of air pockets
(e.g., if instruments are not disassembled correctly or the
loading of the chamber is not correct for the design of the
steam sterilization cycle) results in steam not contacting all
of the set/devices causing a potential sterilization failure.
Air in the load greatly increases the exposure time needed
to achieve sterilization. Dry heat sterilization requires much
 Understanding Steam Sterilization

higher temperatures and also takes much longer than steam is dependent on the sterilizer load and sterilizer design,
sterilization because it is less efficient. A prevacuum cycle requiring validation by the sterilizer manufacturer in
at 270 F (132 degreesC) for 4 minutes at 27 psig (186 kPa) accordance to their instructions for use.
may be the sterilizer’s minimum recommended steriliza-
• Kill time is the time it takes to kill all microorganisms
tion exposure time; however, if steam does not contact the
at a certain temperature, based on testing with bacterial
instrument surfaces, it could take up to six hours at 270 F for
endospores (or spores known as the most resistant to
sterilization to occur.
steam sterilization). A safety factor, accounting for an
additional, overkill time, and usually exceeds 50% of the
kill time.
Ensuring that the total exposure time is accomplished in the
sterilizer load is a responsibility of the sterilizer manufac-
turer, the installation/maintenance staff and those using the
sterilizer to ensure a consistent and reproducible sterilization
process is achieved.

Three Components of Steam Sterilization:

1. Steam Quality, Delivery and Design
Successful steam sterilization remains a probability based on
providing optimal conditions. Appropriate attention must be
given to all steps in the sterilization process (such as condi-
tioning, sterilization hold time and cooling/drying; these are
discussed later in this study guide). Some of the major causes
of steam sterilization failure are: problems with steam satura-
tion and other steam quality requirements, steam (chemical)
purity, incomplete air removal from the pack and or the
chamber, insufficient steam contact and reprocessing errors.
Factors that can prevent steam from contacting all surfaces
include: soil on instrument surfaces, failure to fully disas-
semble and/or fully open instruments, or not flushing lumens
with distilled or sterile water (if the device manufacturer has
not tested). Improper packaging techniques, pulling a wrap
too tight, inadequate air removal, improper loading tech-
nique, and improper maintenance of the sterilizer can also
contribute to sterilization failures.
Heat-up Time + Kill time + Safety Factor
=Total Exposure Time
There is a time-temperature relationship for proper steam
sterilization that has been developed by scientific testing and
is used in all sterilization methods to create what is known
as the total exposure phase. It is composed of the following
components:
• Heat–up time is the time needed to heat up the com-
plete load to sterilizing temperature. The heat-up time
The concept of medical grade steam production is
simple. The boiler receives water from a source and heats
it to generate steam. The steam travels through a steam
line to reach the sterilizer. At the end of the steriliza-
tion cycle, the condensation from the load is removed.
A blow down valve periodically removes impurities and
scale deposits from the boiler and the cycle continues.
The actual steam design and delivery design, critical for a
successful outcome, is not always fully accessible or easily
evaluated by reprocessing technicians.
Steam is easy to make (by heating water), but this does
not mean it is fit for use for medical device sterilization.
Steam can have too-much (oversaturated or ‘wet’) or
too-little (undersaturated or ‘dry’) moisture that can be
inefficient for sterilization. The design of a steam boiler
and steam line system requires some attention and con-
stant maintenance. For example, in steam line systems
the tolerances, slopes, pipe size location and design of
traps (to catch moisture) is more stringent than many
simple industrial designs to prevent the transfer of exces-
sive moisture to the sterilizer (leading to problems such
as water pooling and ‘wet’ packs). The necessary steam
quality may not be produced due to operational and
structural deficiencies in the traps, pipes, and boilers.
Moisture Content
Steam is the sterilant and moisture content is an im-
portant attribute of steam quality. We know that
saturated steam kills microorganisms faster and at lower
temperatures than dry heat. Saturated steam is neces-
sary for effective steam sterilization and is defined as the
proper balance of pressure and temperature resulting in
4
Understanding Steam Sterilization
the correct level of moisture. A steam moisture content
recommendation of 97% steam (water gas) and 3%
moisture (water liquid) has been identified for successful
heat transfer. There are, however, practical considerations
and moisture content of 97% is not always possible at
point of use, so an allowance of 95 to 97 percent is often
quoted. When steam moisture content exceeds 3% mois-
ture, it is referred to as ‘wet’ steam. Wet steam contains
water as well as (gaseous) steam. Water does not have
latent heat, therefore, per unit mass, it has less energy
i.e. water cannot condense (as it’s already condensed).
This is one of the reasons to limit the amount of water in
steam. The excess water means that the likelihood of wet
loads is increased. This is an effect that can be problem-
atic. Steam leaves excessive condensation, cool surfaces
and interferes with the sterilization process by impeding
the transfer of heat to items being sterilized. A device
or package with moisture present following the steam
sterilization cycle is unacceptable and the sterility of the
item cannot be maintained.
When the steam moisture content is less than 3%
moisture, the steam is described as superheated (or dry),
a condition where steam is not at the right temperature
and is too dry for effective steam sterilization.
Remember, dry heat takes much longer to kill microor-
ganisms at higher temperatures and besides being ineffec-
tive at sterilizing, the condition can deteriorate medical
devices prematurely.
Boiler Assessment
A discussion of steam quality identifies it’s importance to
the efficacy of the cycle. It has to be close to perfect. The
discussion then focuses on what factors influence steam
quality in the creation and delivery of steam to the steril-
izer. There are many variables to this. An example is the
constant supply of steam (e.g, at a pressure of 50-80 psig
or 344-551 kPa) must come from the boiler. For this rea-
son, it is typical to find a pressure reducer valve located
near the sterilizer to reduce and deliver the optimum
steam pressure to the sterilizer. If several demands are
made on the steam source for other uses in the hospital
and the pressure is too low, the proper steam temperature
will not be maintained.
For larger hospital steam sterilizers, the boiler system
is usually located in the plant operations at the facility.
Small sterilizers may have a self-contained electric boiler
that makes steam locally. The correct boiler maintenance
can be a particular concern when the boiler is located at a
distance from the sterilizer and is used for many differ-
ent purposes. Both systems require routine maintenance.
5
Both systems also require a treated and correctly main-
tained water supply. Note that whatever is in the water
can also be carried over in the steam, such as various
chemical contaminants; for this reason, the correct water
purity is required to be used. Note that the terms water
purity and quality are often used interchangeably, but
in steam sterilization, purity refers to chemical contami-
nants and quality to the correct saturation of steam for
sterilization. Typical problems with steam sterilization
of devices from water purity will include the presence
of chlorine (leading to rusting and other damage) and
staining/spotting (e.g., from water hardness). Treating
the water can actually lead to other problems (e.g., water
is often treated with chlorine to reduce microbial levels,
but can lead to rusting of devices), so department man-
agers should understand important variables of water
purity and their impact on device reprocessing.
The boiler and it’s components have a direct impact on
moisture and purity issues. Large boilers such as those
located in facilities are often monitored 24/7. Boil-
ers are designed to have an optimum water level, but
high water levels may cause carryover of liquids into
the steam. Large quantities of liquid may overload the
traps and create wet steam, as well as, allowing particu-
late and chemical contamination of the steam supply.
If components of the boiler such as faulty floats, dirty
rods, or chemical additives exhibit foaming, impurities
are carried over into the steam and deposited on the
instruments. Chemical additives are often added to the
boiler to reduce scale, corrosion and maintain the correct
pH. If the chemicals are added correctly and in the right
amounts, no damage should occur to the sterilization
load, but incorrect amounts can produce instrument
damage. Decreased operational costs result when boil-
ers are rotated due to improved efficiency. Preventative
maintenance on traps and components is done during
rotation, but it is recommended to bring the secondary
boiler online before shutting down the primary. Traps
need routine maintenance and particularly following
seasonal changes. Traps wear out and may need to be
replaced as often as sterilizer components on a yearly
replacement schedule. Turning boilers on and off can
also introduce liquid carryover (sometimes known as
priming) into the system causing excessive moisture in
steam.
The sight glass on the boiler should be examined once
a shift and if the water is murky and not clear, these
will be carried over to the instruments. If the sight glass
water level is bouncing up and down and not maintain-
ing a steady water level, it is indicative of an undersized

boiler meeting excessive demands for the steam loads
processed. Inadequate capacity will lead to carry over
in the steam lines, but may only occur under certain
operating conditions. Generally, the higher the steam
pressure, the dryer the steam. Fluctuations in the sight
glass may indicate inadequate pipe size or too much load
on the boiler. Increasing the boiler capacity or staggering
the steam demand may prevent moisture carry over. Ex-
amination of the site glass for debris/sediment/excessive
fluctuation will identify issues with leaks, improper feed
water treatment, or insufficient blow down. Sight glass
levels should be consistent with little fluctuation, clear,
debris-free water, and consistent, proper levels.
Blow down of the boiler is done to prevent scale build
up in the unit. A general work practice is to initiate a
blow down once a shift or daily. Insufficient blow down
procedures lead to debris/foam carryover in the steam
and clogged traps and staining of the sterilizer loads.
Boilers manufacturer’s instructions for use recom-
mend checking the feed water daily. The feed water in
facilities with black iron piping requires treated water
to prevent corrosion. Too little /excessive treatment can
cause rust or foam resulting in trap failure or stained
loads. A daily sample of the feed water treatment is often
recommended for testing.
Piping Assessment
The pipes leading from the boiler to the sterilizer also
plays a large role in carryover and moisture retention
issues. Wet packs and instrument staining occurs when
excessive moisture is introduced into the chamber due to
poor pipe design, insufficient insulation, and poor main-
tenance of the traps. Steam forms condensation against
cool pipe walls. Non-existent or poorly maintained
insulation increases the condensate and forces the traps
to work harder. The purpose of the traps is to remove the
condensate from the steam lines. Traps should be placed
at low points 60 to 100 feet apart. Inadequate spacing,
poor maintenance, insufficient size, and poor location
prevents the condensate from being drained from the
steam system and promotes carryover of liquid and de-
bris. Drip legs should be located ahead of each trap and,
unless maintained, are frequently clogged.
Poor boiler and feed-line design can cause excessive con-
densate in the pipes. All pipes must be sloped for gravity
draining of condensation to the traps. Level piping or
pipe sagging causes moisture to pool and under high
flow condensation will be carried to the sterilizer. The
pipe diameter is essential in preventing excessive conden-
sate in the pipes. The diameter of the pipes affects the
Understanding Steam Sterilization
velocity and capacity of the steam pipes. High velocity
makes it difficult for the traps to remove moisture. Small
diameter reduces volume and causes pressure fluctuation.
For example, the use of 2 inch pipe diameter to reduce
costs will increase pressure fluctuations.
2. The Steam Sterilizer:
Basic Components
Steam sterilization is the only method of sterilization
whose sterilant is not controlled by the sterilizer. Steam
sterilizers are the most controllable and easily monitored
portion of the steam sterilization process. For this reason,
the sterilizer typically represents less than 8% of all steam
sterilization failures exceeded greatly by human operator
error. The principles of steam sterilization may change
little, but upgrades in technology including modifica-
tions in chamber design, and the mechanical action of
the sterilizer makes it possible to process complex multi-
layered set designs constructed with composite materials
and challenging dead spaces.
The basic components of the steam sterilizer consist of
a steam to chamber valve, jacket, chamber, door/gasket,
chamber drain, thermostatic trap, and ejector/vacuum
pump, and gauges/controls. The jacket encompasses the
sterilizer and can have many roles such as heating of the
load/chamber and acting as a separator to help prevent
excess moisture from entering the chamber. Steam from
the boiler/generator fills the jacket keeping the chamber
warm. The warm chamber walls limit the formation of
condensation on the walls of the chamber during steril-
ization. The steam is typically introduced to the chamber
from the jacket. The door of the chamber must maintain
a tight seal during the phases of sterilization to prevent
steam from escaping the chamber, but also to prevent
air from entering during the vacuum/pulsing intervals.
Remember, steam sterilization uses steam under pressure.
6
Understanding Steam Sterilization
The door gasket (or seal) is a critical component to pre-
vent the entry of air or escape of steam during the pro-
cess. The chamber drain is located near the lower front of
the chamber and is the exit for the air being evacuated at
the beginning of the cycle and also the steam/condensate
during the cycle. This site is responsible for sterilization
failures when the screen in the drain is blocked, retaining
air or excessive moisture in the chamber.
In certain types of steam sterilizer designs (known as
prevacuum sterilizers), a vacuum pump or ejector design
is used to assist in air removal and pulling steam into the
chamber during load conditioning and also removes the
steam from the chamber at the end of the cycle. Located
in the drain line is a sensor which measures the steam
temperature to control the entry/exit of steam during the
sterilization cycle. Controls and gauges provide the vital
information needed during the cycle and documentation
for monitoring purposes.
Sterilizer Cycles
Controlling the delivery and amount of steam, the pres-
sure and temperature relationship to attain a successful
sterilization outcome is determined by pre-programmed
sterilization cycles. The specific variables in each cycle
types can vary, but they are defined on how the air
is removed from the chamber during preparation for
steam sterilization. Some simple methods of air removal/
steam penetration can be used for some loads but dense,
multilayered sets and complex device designs depend on
technological advances to dynamically remove air and to
pull steam into the set and device. The sterilizer manu-
facturer will provide a description of the types of cycles
provided and minimum exposure times. The selection of
the sterilizer cycle and exposure time will be based on the
sterilizer manufacturer (and required regulatory claims),
the device manufacturers, and the containment device/
packaging materials used.
Gravity Cycles were one of the first types of cycles
introduced into hospitals. These are still widely used,
such as for some immediate use (‘flash’) sterilization
cycles, preprogrammed into many operating room steril-
izers. Steam enters the chamber and displaces by weight
the air, forcing it through the drain. The drain remains
open until the steam flowing past, reaches the designated
temperature for sterilization. Many gravity cycles are
inefficient for air removal complex loads.
Vacuum Assisted/Pressure Pulsing/Vacuum/Pressure
Pulsing Cycles are all examples of dynamic air removal
methods utilizing various combinations of extracting
7
the air, injecting the steam and heating the load. Air is
removed from the sterilizer by applying a vacuum/ejec-
tor, and then frequently combined with the injection of
steam. The combination of pulling a vacuum to a given
low pressure and then introducing steam (to a given high
pressure) as a series of pulses is an example of a condi-
tioning phase. The various steam pulsing and flushing
effects of high and low pressure optimizes air removal,
steam penetration and aids in rapid load conditioning.
The level of vacuum/pressure, number and methods
of pulsing vary by type of cycle and manufacturer. The
various methods represent advances to achieve efficient
delivery of steam to minimize the time taken for the
sterilization process, condition the load, and reduce
operating costs.
It is important to note that the overall efficiency of these
conditioning cycles and steam sterilization is dependant
on utilities and parameters specified by the sterilizer
manufacturer. Inefficient steam delivery, quality or pu-
rity can interfere with cycle operation and may cause wet
packs. It is equally important to remember that success-
ful sterilization will also depend on the correct mainte-
nance and use (in particular loading) of the sterilizer.
Cycle Phases
All sterilization cycles are composed of at least three
phases: conditioning, exposure and exhaust.
Conditioning Phase
The conditioning phase is the beginning of every cycle
when air is removed from the chamber/load and the
load is heated to the defined sterilization temperature
(under pressure). The various types of conditioning
cycles (such as gravity and dynamic) have been described
above. When all the air is removed from the chamber
and the temperature and pressure is reached for the cycle
selection, the exposure phase can begin. Note that the
manufacturer validates that this occurs under labora-
tory conditions with defined loads, but this needs to be
verified in hospitals specifically for the types of load that
they may use.

Exposure Phase
When the conditioning phase is completed and the
chamber temperature and pressure necessary for the ster-
ilization cycle selected has been met, the exposure phase
begins. The time, temperature, and pressure are dic-
tated by the type of cycle selected and vary by sterilizer
manufacturer, based on validation testing, in accordance
to various standards and regulatory bodies (e.g., the
US-FDA). Operator manuals should give the recom-
mended minimum exposure times based on the cycle
selected and a description of the types of loads that can
be sterilized in each cycle design (e.g., liquids). Though
exposure times can be lengthened, they can never fall
below the recommended time provided by the sterilizer
manufacturer. It is frequently reported that hospital op-
erators wish to extend the exposure time based on device
manufacturers instructions, but this should not be the
case if load conditioning has been successful (and cor-
rectly tested by the device manufacturer). Any changes
in sterilization cycle conditions should be authorized in
a hospital policy, recorded and correctly verified to be
effective and not damaging to device or equipment prior
to routine use.
Exhaust Phase
The last phase of the sterilization cycle is the exhaust
phase, to allow the load to be released. In a gravity
displacement cycle, this can be achieved by opening the
drain and allowing the temperature and pressure to drop.
In dynamic air removal cycles, steam can be actively ex-
hausted (using a vacuum pump) and filtered air injected
to aid in the drying and cooling process. Drying may or
may not be validated by the manufacturer. When speci-
fied, the dry time and conditions are established by the
sterilizer manufacturer based on cycle selection and vali-
dated based on guideline and standard testing. Dry time
may need to be increased based on varying load volumes,
device design and complexity, set weights, and the use of
multi-layered sets. Required and increased dry times can
often exceed sixty minutes, based on the sterilizer design
and load specification.
3. Sterilizer Loading and Unloading
Loading of the sterilizer should consider adequate room
between the sets to facilitate air removal and steam
penetration, as well as, improved drying. Special instruc-
tions are often provided in the operator’s manual (and in
various best practice guidelines) to prevent overloading
of the chamber based on set weights, total number of
instrument trays and fabric packs processed in each load.
Additional recommendations in the operator manual
Understanding Steam Sterilization
include the use of mesh or trays with perforated bottoms
to aid in sterilization efficacy. Wrapped instrument sets
and rigid containers should be loaded flat on the shelf
not only to aid in air removal, but to prevent damage to
the instruments and clumping of the metal mass leading
to moisture issues. It is important to split the loads and
run additional cycles, if wrapped sets and rigid contain-
ers are processed on edge or tilted on the shelf. Basins
and solid bottom trays capable of retaining water should
be placed on their sides and oriented in the same direc-
tion to eliminate condensation. Utensils and treatment
trays without instrumentation should be placed on their
edges to facilitate steam penetration and prevent mois-
ture retention. Fabric packs should be loaded loosely
and placed with folds perpendicular to the shelf (layers
should not be stacked flat) to aid in steam penetration.
Peel packs are placed on their side with plastic facing
the paper side of the next peel pack and devices sepa-
rating the packs are commercially available. Peel packs
crammed together to remain on their edge present a
challenge to steam penetration. No load should make
contact with the walls of the chamber and the heaviest
container should not be placed over the drain.
Segregating loads based on cycle parameters is recom-
mended and process audits should be conducted to
verify compliance. Loads are additionally segregated,
based on extended drying time requirements and load
types. Separating textiles from wrapped sets and rigid
containers is recommended, however, if mixed loads are
processed, textiles should be placed on top with metal
items below. Rigid containers should never be placed
above any wrapped sets or peel pouches. Documenta-
tion of set placement on the shelves is recommended to
ensure compliance.
Unload the sterilizer only after verifying the correct cycle
was selected for the load’s content and the parameters
were met. The sterilizer and shelves will be hot on the
completion of a cycle and protective oven gloves and
an apron is recommended to prevent burns. Steam may
be released from the chamber, so stepping back from
the door will minimize contact with the steam. When
removing the loading carriage from the sterilizer, verify
no visible moisture is present on the exterior packaging.
Visible moisture renders the set unacceptable. Items on
the loading carriage must not be touched and remain on
the carriage until the designated cool down is com-
pleted. Thirty minutes is the minimum recommended
cool down time, however, larger sets and rigid container
devices may require more than 2 hours to reach room
temperature. The loading carriage should not be placed
8
Understanding Steam Sterilization

by air conditioning ducts or cool air vents. The door to package processed also contains an internal CI placed
the sterilizer should always be closed after the load is in the area of greatest challenge in the set. Multiple CI’s
removed. When the sets have reached room temperature, may be placed in complex sets, but a minimum of one
they may be removed from the loading carriage and per tray is recommended. CIs come in a range of clas-
transferred to storage. sifications, such as Class 1 indicators, that are generally
provided on the outside of packaging, to alert any user
Small sterilizers without loading carriages follow a similar
or technician that the pack was exposed to steam and is
procedure. Sets may not be touched until they have
part of the process used to release a cycle. In contrast,
reached room temperature and all unnecessary handling
class 5 indicators are designed to correlate with the BI’s,
is avoided. A loading tray for the set should be utilized
and Class 6 to the whole sterilization exposure time. A
and care taken that no direct contact is made upon
PCD provides a greater challenge to a steam process,
removal from the sterilizer shelf. A tray handle or thermal
offering a higher resistance to change. Other indicators
glove can be utilized to remove the loading tray from
can include the use of Bowie-Dick tests (a specific test
the sterilizer to prevent a thermal burn. The loading tray
for the removal of air from and steam penetration into
should never be placed on any cool surface to prevent the
porous load), helix tests (lumen penetration) and BIs
formation of condensation in the set. It is recommended
(providing a known concentration of bacterial spores
the loading tray (containing the processed set) be trans-
of a known resistance to steam). These various types of
ferred to a padded surface for cooling.
indicators are often specified by various manufacturers
Sterilization Process Monitoring and in guidelines/standards for good clinical practice.
Physical Monitors (such as temperature and pressure Recommendations can vary from country to country,
monitors) in parallel with various Chemical Indicators but an example will include:
(CI’s), Biological Indicators (BI’s), Process Challenge
Packs (PCD’s), and package/load identification, are
Routine sterilizer efficacy monitoring covers the
physical monitoring of the sterilizer, external and in-
vital to ensure the success of steam sterilization, as well
ternal chemical monitoring of packages, weekly, prefer-
as, for any epidemiological tracking of sets and loads of
ably daily, PCD monitoring (PCD with a BI and may
concern. Each of these elements play a vital role in an
contain a CI), and Bowie Dick testing. The PCD testing
ongoing Quality Assurance Program. Process monitoring
in larger sterilizers (greater than 2 cubic ft) and table top
can be divided into routine monitoring of every load and
sterilizers should be run in a full load. Immediate Use
package, routine sterilizer efficacy monitoring, sterilizer
Steam Sterilization (IUSS), formerly known as flash ster-
qualification testing (after installation, relocation, mal-
ilization cycles, should be processed in empty loads, and
functions, major repairs, sterilization process failures),
each type or tray configuration in routine use, should be
and periodic product quality assurance testing (reviewed
tested separately (in the area of greatest challenge). The
under set design).
Bowie–Dick test is run in the first load of the day in an
Routine Load and Package monitoring empty chamber. All loads require the review of the print-
Each package in the load is provided with a lot number, out to verify the printer is functioning correctly and the
which typically identifies the sterilizer, the date and cycle correct cycle/exposure time/and dry time was selected.
run (load number of sterilizer) and provides product At the completion of the cycle, sterilization parameters
traceability. The lot number identification/label may are verified with the load and cycle information and the
also provide any expiration statement or date to facilitate printout is initialed before the load is released.
stock rotation. In the event of a recall or a wet pack, the
personnel can trace or retrieve items back from circula-
Sterilizer qualification testing is done on instal-
lation of a sterilizer, after a major repair, relocation, or
tion. Sterilization records for every load processed will
sterilization process failures. For sterilizers larger than 2
also include the sterilizer ID, date and time, specific
cubic ft and IUSS sterilization cycles, the PCD with a
contents of the load, lot number, the exposure time and
BI should be run three times consecutively in an empty
temperature, type of cycle, identification of the operator,
chamber, except for table top sterilizers, which should
and results of indicator testing if applicable (such as CIs,
be run in a full load. If a sterilizer is capable of multiple
PCDs, and BIs). For paper copies, an initialed print out
types of cycles, each type of cycle will be tested three
from the load should be kept with the sterilization load
consecutive times, however, the shortest sterilization
records for easy review and audit purposes. Every set and

9

exposure phase for the type of cycle is selected. Once the
PCD challenge is completed, three consecutive Bowie-
Dick tests should be run in an empty chamber.
Sterilization Process Challenges
Set Design
The sterilizer manufacturer provides guidelines for set
maximum weights and number of sets processed in the load,
based on chamber size. The manufacturer also provides
spacing recommendations to prevent overloading the steril-
izer during a cycle. The focus of set design is also to facilitate
the removal of air and assist steam penetration. Set design
incompatibility with the steam sterilization process continues
to escalate and many factors contribute to sterilization fail-
ures. A greater challenge can occur in complex sets that are
represented by a routine PCD. Due to increased set complex-
ity, periodic product quality assurance testing of routinely
processed items is recommended on a scheduled ongoing
basis. Product families have been established in hospital sets
representing worst case scenarios to group products based
on construction, materials, packaging and design. Recom-
mendations for product testing based on tray configurations
can be found in guidelines such as the ANSI/AAMI ST79:
Comprehensive guide to steam sterilization and sterility as-
surance in health care facilities (chapter 10).
The central sterile technicians and nurses are accountable for
proper steam sterilization throughout the facility and should
be provided with all sets, containers, and devices for product
assurance testing prior to any purchase by the facility. New
purchases should be contingent on successful testing out-
comes.
Recommended maximum set weight is 25 lbs and includes
the rigid container. The weight limit recognizes that the
more metal mass present, the greater the chance moisture is
retained from condensation pooling and instrument steam
contact impedance due to overloading. Weight alone may
not cause a sterilization failure or wet pack. Sets over 25 lbs,
but designed with multiple metal stacking trays with numer-
ous perforations and copious space between the metal items,
may easily pass the sterilization and drying challenges. This
same set may fail if the tray is made of composite material
with few perforations and no space between the items. Add
a silicone mat with no holes and the failure quotient rises.
In reverse, a 12 lb semi-solid metal instrument may always
be wet after cooling, due to the metal denseness leading to
excessive condensation.
Distributing the metal mass evenly in the tray and keeping
it to a single layer aids in air removal and steam penetration.
Understanding Steam Sterilization
The condensate formed by grouping multiple heavy metal
handles in a rigid container on a silicone mat (with few
perforations) will not reabsorb/revaporize. Removing the
mat and distributing the handles throughout the tray could
cause the set to pass product testing. If large concentrations
of metal mass are localized in a small area, the amount of
condensation produced is relative to its size and density,
and with too much moisture produced to dry. Placing three
stringers on top of each other presents too great a challenge.
The weight from the instruments prevents air removal, effi-
cient steam penetration and creates drying issues. A solution
may be adding an additional tray to the set and spacing out
the instruments. A single layer of instrumentation will fail
if they are not disassembled and/or strung on the appropri-
ate size stringer. A long needle holder requiring a five inch
width stringer does not belong on the smallest stringer
available. One size does not fit all. Designing the set properly
will require more depth to the tray to accommodate a wider
stringer.
Close attention to accessory/tray/container design and mate-
rial composition for ease of air removal and steam penetra-
tion improves product testing results. Mixing metal items
and trays with non metal items (plastic organizing trays,
silicone mats, vendor cassettes) can create moisture issues
inside sets, due to different drying characteristics. Large or-
thopedic vendor sets, with multiple composite cassettes and
few perforations, should be inspected for moisture retention
and are ideal for product assurance testing. These sets may
require additional sterilization exposure and drying times.
Sterilizer Maintenance
Preventative maintenance is done at manufacturer recom-
mended intervals by a qualified technician. Regular preven-
tative maintenance and operator maintenance is necessary for
safe and reliable operation of the sterilizer. Many parts and
valves are replaced frequently throughout the year, due to
10
 Understanding Steam Sterilization
wear. Documentation should be kept and include the opera-
tor’s checklist of daily and weekly functions included in an
easy to use format. Operator maintenance would include the
daily cleaning of the drain screen and inspection of the door
gasket for cracks/tears. The entire chamber should be wiped
down and rinsed after spills, but it is no longer necessary
to do a weekly chamber cleaning if no residue or spills are
present on chamber walls. Deposits on chamber walls can be
transferred to packaging or the inside of sets. Weekly main-
tenance includes flushing the chamber drain or whenever the
line becomes clogged. Always refer to your operators manual
for detailed maintenance instructions.
Moisture Issues
Determining root causes for the presence of moisture
(wetness) on or in packs requires specific investigation. A
moisture assessment sheet should document:
• Sterilizer ID
• Type of Cycle: Gravity or Prevacuum
• Date and Time
• Wet items
• Type of Moisture: External Moisture/Internal Moisture
and any comments (under silicone mat, bottom of rigid
container)
• Location in the Load
• Exposure Time and Temperature
• Dry Time
Most wet pack issues are periodic in nature, focusing atten-
tion on two main causes: variability in the steam supply (and
its quality) and variability in the types of loads being pro-
cessed. Documenting when and where wetness is observed
is critical to understanding the root cause(s) and resolving
them. There are many excellent reference guides.
External Moisture investigations should focus on where on
the load the moisture was found. It is localized moisture, if
the water droplets can be associated with a particular loca-
tion. Moisture found on shelves and rails may be inadequate-
ly removed at the end of the cycle. If packs are placed under
the drip rails, moisture droplets will form on the exterior of
the pack. The drip rails are in place to direct moisture away
from items being sterilized. External moisture can be directly
attributed to wet steam generated in the boiler, in clogged
traps or drip legs in the steam delivery pipes, or in poorly
sloped piping systems. Steam quality is easily identified, if
the moisture is found where the steam enters the chamber.
11
Dispersed moisture may come from the shelves above the
packs. Dispersed moisture may vary in amounts, but can
be distributed throughout the entire load. The entire load
may have a feeling of dampness or uniform beads on peel
packs. This can be associated with steam quantity, vacuum
rate, or inadequate dry time. Improper loading by placing
rigid containers on top of wrapped sets or peel packs leads
to moisture formation on the packs below. The dry time
may be inadequate for the load size or set density. Dense and
heavy sets also interfere with the removal of moisture in the
exhaust phase. Overloading the sterilizer can cause external
and/or internal moisture. A hand should easily slide between
all sets on the loading shelves to aid in air removal, steam
penetration and the removal of moisture during the exhaust
phase. Equipment failure, such as a faulty thermostatic trap,
can lead to external moisture.
Internal Moisture has been discussed in set design when
instruments are not evenly distributed and the metal mass
is too dense. Solutions were found in using larger trays and
dividing the set into two trays. Mixing of plastic composites
with metal items and the use of packaging material (peel
packs in wrapped or rigid containers) not cleared for internal
use can lead to wet packs. Use of a wrapper that is too large
for the set will add folds increasing the barrier challenge. A
review of trays, liners, and device placement, with the goal to
increase the flow of air in the set and increase the extraction
of moisture at the end of the cycle, is the first step in reduc-
tion of moisture in complex sets. External causes can also
contribute to moisture retention within the set. Utilities not
meeting the equipment specifications (e.g., steam saturation)
and inadequate equipment maintenance contributes to in-
ternal set moisture. An obstructed drain screen can cause air
retention and prevent steam removal at the end of the cycle.
Monitoring Failures
Monitoring failures indicating inadequate sterilization
are frequently associated with the same issues discussed

previously under moisture issues, utility requirements,
set design, load errors, and mechanical failure. When air
removal, steam penetration, and moisture removal are com-
promised, we should see a failed BI or CI. Faulty chamber
valves or door leaks could be responsible for a failed Bowie–
Dick and all sterilization process failures must be investigated
and the sterilizer taken off line until a resolution is identi-
fied. If a printout review of the cycle parameters indicates
sterilizer malfunction, then service should be notified and
that load considered non-sterile. The sterilizer remains down
until a repair is complete. When a simple processing error
is identified, such as a BI processed in an incorrect cycle,
three consecutive PCD challenges will not be necessary, but
when a major repair to the utilities or sterilizer is done, it will
require the three consecutive PCD challenges before bringing
the sterilizer on line.
For a failed PCD challenge, the supervisor and infection
preventionist will be notified. The verbal notification will be
followed by a written report and contain: sterilizer ID, date
and time, cycle type, load ID, results of the physical moni-
toring and the CI results from any opened sets. In addition,
any information that is pertinent and identifies cause and
effect including personnel errors will be recorded. If the cause
is confined to one load and easily corrected and identified
and affects no other loads, a product recall of previous loads
based on lot numbers is not necessary. All items processed in
that load will be considered non-sterile and reprocessed and
repackaged appropriately. If the failure cannot be identified,
a load recall requires the collection of all the loads processed
since the last negative BI. If a positive BI caused the PCD
failure, the BI should be sent to the lab for identification of
the microorganism. A team approach involving central pro-
cessing, infection control, facilities, and the microbiology lab
to identify the cause of the sterilization failure and map out a
corrective action plan is recommended. The sterilizer remains
out of service if a major repair is required. After the repair is
complete, three consecutive BI PCD challenges followed by
three consecutive Bowie-Dick indicators for vacuum assisted
sterilizers is done.
Manufacturer’s Instructions for Use (IFU’s)
Close inspection should be paid to IFUs, both for the steriliz-
er manufacturer and the device manufacturers. Pay particu-
lar attention to any limitations, such as not exceeding certain
pressures or temperatures, as well as, the correct preparation
of the device for sterilization. Sometimes conflicts occur. An
example is that many device instructions have recommended
extended steam sterilization exposure times based on the
device manufacturer’s testing. Many of these tests may not
Understanding Steam Sterilization
have typical steam conditioning cycles that are used in clini-
cal practice and would not require an extended steam cycle,
while others are a concern, due to the weight and complexity
of the load. Many devices and sets will also require extended
dry times to prevent wetness remaining in the load, but such
cycle conditions may stress and even damage other devices.
As an example, sixty minute dry times have been noted
on some orthopedic sets. Though an extended sterilization
exposure phase does not automatically mean an extended
dry time, it increases the possibility. Manufacturers of sets/
devices may provide IFU’s stating to follow your hospital’s
policy on sterilizing and preparing the instruments. When
this occurs, it requires further investigation, including a call
to their testing department, to track how the device was
sterilized. Often the specific device testing lags behind the
recommendations and not all device specific model and set
configurations have completed testing. Notifying the device
manufacturer of process failures detected during product
quality assurance testing (from moisture retention and/or
positive indicators) aids in moving that set to the top of the
queue. Set inserts provided by the device manufacturer to
protect delicate instrumentation may create a barrier to steam
penetration. It remains a massive undertaking to collect all
the IFU’s and often the instructions can be found online. If a
computerized system is not available, placing the IFU sheets
in easily accessed areas at point of use is recommended.
Breaking the data collection into specialties may speed the
process. Sterilization failures may occur when following
the manufacturer’s instructions for use. A rigid container
manufacturer may recommend a silicone mat as a tray liner,
yet during product testing you may find BI failures/moisture
issues in the set. All specialty device IFU’s (scopes, batteries,
cords, cautery, etc. should include cleaning instructions and
sterilization instructions inclusive of disassembly, lumens
tested without flushing with sterile or distilled water prior to
sterilization, cycle type and parameters, placement in tray.
12
 Understanding Steam Sterilization
Summary
Steam sterilization is a complex process and sterilization
failures are prevented by an understanding of the importance
of every step in the process. Comprehensive knowledge of
the following is necessary to develop a quality assurance
program:
• Device and set design
• Instrument preparation and packaging
• Sterilizer loading
• Monitoring of the loads and equipment, including the
steam supply
• Correct installation and maintenance of the steam supply
and sterilizer equipment
Even the simplest changes can affect the removal of air,
penetration of steam, and moisture evacuation for the good
or bad. Due to the increasing complexity of sets/devices,
changes in packaging and tray material, load weights, and
aging utilities, close attention to all the above factors are
necessary for successful outcomes. Every member involved in
the sterilization process must continuously assess the steam
process to achieve a standardized result focused on the deliv-
ery of a sterile device.
13
Review the following actions when processing devices/sets:
• Review, collect and implement the device manufacturer’s
instructions for use for cleaning, preparation and steam
sterilization
• Select trays, liners, and accessories that increase air re-
moval, steam penetration, and moisture evacuation
• Provide specific instructions at point of use for type of
cycle, sterilization exposure time, and dry time
• Reduce set density, distribute instruments evenly, and
divide sets if necessary
• Ensure proper loading of sterilizer:
◦◦ adequate air circulation around sets
◦◦ wrapped sets and rigid containers flat
◦◦ basins positioned for moisture removal
• Readily identify those sets requiring extended steriliza-
tion exposure and dry times and segregate the loads
• Institute a program to periodically test routinely steril-
ized products based on product families
• Ensure operator’s routine maintenance of sterilizer is
completed and documented
• Use the team approach with facilities to develop docu-
mentation tools for maintenance of steam delivery
system
• Complete periodic process audits for compliance with
processing policies
• Review the sterilization records for completeness and
to identify process failures (ex. wrong exposure time
selected)
• Audit peel pouch practices: lightweight instruments,
water spots on paper side, no folded inner pouches, no
ridges on seal
• Use copied printouts as competency tools to test staff
knowledge of type of cycle, exposure time, temperature
and pressure range, and cycle phases
• Examine instruments, trays, and containers for staining,
pitting, discolorations, and functionality

Glossary
Gravity Cycle
Type of sterilization cycle in which incoming steam displaces
residual air through a port or drain in or near the bottom
(usually) of the sterilizer chamber.
Prevacuum Cycle
One of two types of sterilization cycles in which air is
removed from the chamber and the load by means of a series
of pressure and vacuum excursions (prevacuum cycle) or by
means of a series of steam flushes and pressure pulses above
atmospheric pressure (steam-flush pressure-pulse [SFPP]
cycle).
Exposure Time
Period for which the process parameters are maintained
within their specified tolerances.
Heat-up Time
Time required for the entire load to reach the selected steriliz-
ing temperature after the chamber has reached that tempera-
ture.
Installation Qualification Testing
Process of obtaining and documenting evidence that equip-
ment has been provided and installed in accordance with its
specifications.
Manufacturer’s Instructions for Use
Written recommendations provided by the manufacturer of
a device that provides instructions for operation and safe and
effective processing.
Performance Qualification Testing
Process of obtaining and documenting evidence that the
equipment, as installed and operated in accordance with
operational procedures, consistently performs in accordance
with predetermined criteria and thereby yields product
meeting its specification.
Process Challenge Device (PCD)
Item designed to constitute a defined resistance to a steriliza-
tion process and used to assess performance of the process.
Understanding Steam Sterilization
Product Family
(Sterilization) group or subgroup of product that is character-
ized by similar attributes, such as mass, material, construc-
tion, set weight, shapes, lumens, and packaging system, and
that presents a similar challenge to the sterilization process.
NOTE—In grouping products by construction, it is neces-
sary to consider size and/or surface area, surface finish or
texture, and the presence of any cannulations, lumens, or
mated surfaces.
Saturated Steam
Water vapor in a state of equilibrium between condensation
and evaporation.
Steam Purity
Degree to which steam is free of dissolved and suspended
particles, water treatment chemicals, and other contaminants
Steam Quality
Steam characteristic reflecting the dryness fraction (weight
of dry steam present in a mixture of dry saturated steam and
entrained water) and the level of noncondensable gas (air or
other gas that will not condense under the conditions of tem-
perature and pressure used during the sterilization process).
Steam Sterilization
Sterilization process that uses saturated steam under pressure,
for a specified exposure time and at a specified temperature,
as the sterilizing agent.
Sterilization
Validated process used to render a product free from viable
microorganisms.
Sterilizer, Steam:
Sterilizer that uses saturated steam under pressure as the
sterilant.
Validation
Documented procedure for obtaining, recording, and inter-
preting the results required to establish that a process will
consistently yield product complying with predetermined
specifications.
14
 Understanding Steam Sterilization

References and Suggested Reading:

Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in
health care facilities. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011. Arlington (VA)

International Association of Healthcare Central Service Materiel Management. Central service technical manual. 7th ed. Chicago:
IAHCSMM, 2007.

Association of perioperative Registered Nurses. Recommended practices for sterilization in the perioperative practice setting. 2011
Edition In: Perioperative standards and recommended practices. Denver (CO):

A Practical Guide to Decontamination in Healthcare, First Edition. G. McDonnell and D. Sheard. 2012 Blackwell Publishing Ltd.
STERIS Corporation, “Preparing instruments, utensils, and textiles for sterilization and Wet pack problem solving “ 2003

Deacon, Walt. “What is steam quality : Why is it important to the CS department? Thermo-Diagnostics, September. 2008

Central Services Technical Manual, Seventh Edition. International Association of Healthcare Central Service Materiel Manage-
ment, 2007. Chicago, IL

Eliminating Stained Instruments by Controlling Steam Quality, R. Strauss, Journal of Hospital Supply, Processing and Distribu-
tion, Jan/Feb 1984

Principles & Methods of Sterilization in Health Sciences, 2nd Ed., J.J. Perkins, (Springfield, IL: Charles C. Thomas Publisher,
1969)

Lee S. Steam sterilization: Troubleshooting wet pack problems. In: Reichert M and Young JH. Sterilization technology for the
health care facility. 2nd ed. Chapter 18. Gaithersburg (MD.): Aspen Publications, 1997.

Canadian Standards Association. Effective sterilization in health care facilities by the steam process. CSA Z314.3-09.

Ontario, Canada: CSA, 2009.

Canadian Standards Association. Updated AAMI guidelines: ST 46 Steam sterilization and sterility assurance in healthcare facili-
ties CSA

ISO 11134: (1994) Sterilization of health care products- Requirements for validation and routine control- industrial moist heat
sterilization

EN:285 Steam Sterilizers –Section 24 Steam quality tests

15
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