1. HIGH TEMPERATURE
STERILIZATION
Chapter 15

2. Objectives:
• As a result of successfully completing this chapter, students will
be able to:
• Discuss factors that impact the effectiveness of sterilization and the
methods of heat transfer associated with high temperature
sterilization.
• Discuss the advantages of steam sterilization.
• Explain the anatomy of a steam sterilizer and identify the function of
each major component.
• Sizes of steam sterilizers
• Jacket
• Door, Gasket, and Chamber Drain
• Thermostatic Trap
• Gauges and Controls

3. Objectives:• Provide basic information about the types of steam sterilizers
• Tabletop
• Gravity Air Displacement
• Dynamic Air Removal
• Steam Flush and Pressure Pulse
• Special Purpose Sterilizer (Flash)
• Special Purpose Sterilizer (Instrument Washer Sterilizer)
• Provide basic information about the phases in a steam sterilizer
cycle:
• Conditioning
• Exposure
• Exhaust
• Drying

4. Objectives:• Describe the conditions necessary for an effective steam sterilization
process:
• Contact
• Time
• Temperature
• Moisture
• Explain basic work practices for steam sterilization:
• Preparing devices and packs for steam sterilization
• Loading a sterilizer
• Unloading a sterilizer
• Controlling wet packs
• Cleaning and maintaining sterilizers

5. Objectives:
• Explain the basics of dry heat sterilization:
• When dry heat is appropriate.
• Advantages and disadvantages of dry heat sterilization.
• Types of hot-air convection sterilizers.
• Dry heat sterilization procedures.
• Explain the need for quality control and review sterilization process indicators that
help assure quality control:
• Need for quality control
• Chemical indicators.
• Sterilization load control information.
• Physical and mechanical monitors.
• Biological indicators.
• Bowie-Dick tests
• Validation and Verification processes
• Review the basics of three special high temperature sterilization concerns:
• D-values and sterilization effectiveness
• Creutzfeldt-Jakob disease (CJD)
• Solutions

6. Common Methods of Heat
Transfer
• Conduction – Heat
transfer from one part of
an item to another
• Convection – Heat
transfer from one point to
another as gas or liquid
circulates

7. Factors and Conditions that
Impact Sterilization
• Type of microorganisms present
• Number of microorganisms present. (Bioburden)
• Amount and type of soil present
• Amount of protection the medical device provides

8. BIOBURDEN
The number of microorganisms on a contaminated
object; also called bioload or microbial load

9. Steam Sterilization

10. Advantages of Steam
Sterilization
• Low Cost
• Fast Cycles
• Relatively Simple
Technology
• Leaves No Chemical
Residues or By-
products Behind

11. Steam Sterilizers
come in Many Sizes

12. ANATOMY
of a Steam Sterilizer

14. Door Gasket

15. Chamber Drain

16. THERMOSTATIC TRAPTHERMOSTATIC TRAP

17. Gauges, Controls, and Monitors
Provide a Visual and Written Record of Sterilizer Cycles

18. TYPES OF STEAM
STERILIZERS

19. TABLE TOP STERILIZERS
Frequently used in Clinics and
Dental Offices

20. Water Port on a Tabletop Sterilizer

21. GRAVITY AIR DISPLACEMENT
STERILIZERS
Steam sterilizer that uses gravity to remove air
from the chamber. As steam enters the gravity
sterilizer chamber, cooler air is forced out
through the chamber drain

22. DYNAMIC AIR REMOVAL
STERILIZERS
Steam sterilizers that use a vacuum pump or
ejector system to mechanically remove air
from the chamber

23. GRAVITY AND DYNAMIC
AIR REMOVAL
STERILIZERS
Differ in their methods of air
removal

24. STEAM FLUSH- PRESSURE
PULSE STERILIZERS
Steam sterilizers that use a repeated
sequence of steam flushes and pressure
pulses to remove air from the chamber

25. SPECIAL PURPOSE PRESSURE
STERILIZERS
(FLASH STERILIZERS)
Steam sterilizers that are surgical instrument
located at point-of-use. They are intended to
be used in emergencies when there is no
time for terminal sterilization.

26. SPECIAL PURPOSE PRESSURE
STERILIZERS
(INSTRUMENT WASHER STERILIZERS)
Combination units that wash and sterilize
instruments to make them safe for handling
by processing personnel

27. Terminology
• Terminal Sterilization – The process of
sterilizing an item that is packaged
• Flash Sterilization – The process of sterilizing
an item that is not packaged

28. Steam Sterilizer Cycle
Phases
• Conditioning
• Exposure
• Exhaust
• Drying

29. Steam Enters the Chamber

30. Steam Passes through the
Thermostatic Trap

31. Closed Thermostatic Trap

32. Steam is Exhausted
from the Chamber

33. DRYING
Begins at the completion of the exhaust
phase if packaged items are in the load
Flash (unwrapped) loads have minimal drying
times and in some cases, no dry time at all

34. Conditions Necessary for
Effective Steam Sterilization
• Contact
• Time
• Temperature
• Moisture

35. Frequent Causes of
Steam Contact Failures
• Failure to adequately clean the object being sterilized
• Packages wrapped too tightly
• Loads that are too crowded
• Containers that are positioned incorrectly
• Clogged drain strainer
• Mechanical malfunctions

36. Temperature Requirements
• Steam sterilization must take place at specific
temperatures in order to destroy heat resistant bacteria
• The two most common temperatures used are:
• 2500
F (1210
C)
• 2700
F-2750
F (132.20
C-1340
C)

37. TIME
In order for steam sterilization to be effective,
all items within the load need to be exposed
to a specific temperature for an adequate
amount of time

38. MOISTURE
Adequate moisture is required for steam
sterilization to be effective

39. SATURATED STEAM
Steam that contains the maximum amount of
water vapor. The moisture content of
saturated steam should possess a Relative
Humidity of 97% to 100%

40. Preparing Devices and Packs
for Steam Sterilization

41. Preparing Items for Steam Sterilization
• Use instrument trays that are large enough to evenly
distribute that metal mass
• Use only non-linting materials when assembling sets and
trays
• Remove stoppers and tubes from drainage bottles and
tubing from hemostats and clamps
• Position items to allow for sterilant contact
• Disassemble all multi-part instruments
• Do not hold instruments together with rubber bands
• Open all jointed instruments

42. • Items with concave or broad, flat surfaces should be
placed on edge
• Heavy instruments should be arranged to they will not
damage more delicate items
• Complex instruments should be prepared and sterilized
following manufacturers’ instructions
• Central Service Technicians must test and evaluate
protective organizing cases sterilization and drying
• Instruments must be inspected to ensure that they are
clean
• Instruments should be dry, with the exception of lumens
which should be moistened
Preparing Items for Steam
Sterilization

43. Catheters, Tubing, Rubber,
and Other Goods
• Due to it’s rough molecular structure, rubber is
difficult to clean
• Rubber can break down when exposed to heat,
light, acids, solvents, petroleum products, ether
and hot metal
• Most rubber items are single-use items
• When processing reusable rubber items, follow
manufacturer’s guidelines carefully for cleaning
and sterilization

44. WOOD AND CORK
Cannot be sterilized by any hospital
sterilization method

45. OILS AND POWDERS
Cannot be sterilized by steam

46. NO ITEM SHOULD BE
STERILIZED…
Without written instructions
from the manufacturer

47. Paper/Plastic
Pouches
• Should be used for
small, lightweight
items

48. Small Perforated Boxes
• Should be used to
contain small items
within instrument sets
• Paper/Plastic pouches
should not be used in
trays

49. Textile Packs
• Should be made of materials that allow adequate air
removal and steam penetration
• The manufacturer should be consulted for
recommendations on package size and density

50. Basins and Basin
Sets• Graduated, nested basins should differ in
diameter by at least 1 inch
• Basin sets should be prepared so all basins are in
the same direction to facilitate drainage and air
removal
• Non-linting absorbent material should be used to
separate the basins
• Basin sets should not exceed 7 pounds in weight

51. Glass Syringes

52. Lumens
• Moisten with distilled or
demineralized water
• Do not moisten more than
2 hours prior to
sterilization

53. Loading the Steam
Sterilizer
• Allow for proper steam
circulation

54. Allow Adequate Space to Facilitate
Air Removal and Drying

55. Position solid bottomed items so
that water and air are not trapped
inside

56. When using Paper/Plastic Pouches
• Remember that only
the paper side allows
air removal, steam
penetration, and
drainage

57. Stand Paper/Plastic Laminate on Edge
(Use a holder if necessary)

58. Do Not Lay Paper/Plastic Laminate
Pouches Flat

59. Lay items with
perforated bottoms flat

60. Where Water Cannot Flow,
Steam Cannot Go

61. Position Textile Packs so Layers within
them are Perpendicular to the Shelf

62. Unloading the Steam Sterilizer
• Open the sterilizer door according to protocol
• The load should be free from any visible liquid
• Wet items should be considered contaminated
• Do not touch items that have just been removed
from the sterilizer
• Do not handle packages until they are cool

63. Controlling Wet
Packs
• Packages are considered
wet when moisture in the
form of dampness or
puddles of water are found
on or within a pack
• Wet packs are considered
contaminated

64. Causes of Wet Packs
• Wet packs may be the
result of improper
placement or positioning
of packs or their contents
• Pack density can also
increase the incidence of
wet packs.

65. Assembling and Wrapping
Instrument Sets
• Use only instrument trays with mesh or perforated
bottoms to reduce the risk of wet packs
• Use lint-free tray liners to help absorb moisture
and facilitate drying
• Evenly distribute set weight

66. CLEANING AND
MAINTAINING
Steam Sterilizers

67. Routine Sterilizer Maintenance

68. Clogged Drain Strainers
Can Impede Air Removal

69. Wipe the Door Gasket.
Inspect for Signs of Wear and Defects

70. Sterilizer Cleaning and Maintenance
• Routinely clean sterilizer carts, carriages, and baskets
• Inspect recording devices, paper charts and printer paper

71. Sterilizer Cleaning and
Maintenance
• Clean the sterilizer chamber according to manufacturer’s
recommendations to prevent residue build up
• Check the Chamber Drain Strainer at least daily
• Clean and Check the Door Gasket Daily
• Clean the inside of the chamber with a non-abrasive
cleaner
• Follow Manufacturer’s Specific Instructions

72. Dry Heat Sterilization

73. Dry Heat
Advantages
• Sterilizes some items that
Steam cannot sterilize
• Can sterilize assembled
instruments because of
conduction heating
• Will not erode the surface
of glass
• Is not corrosive to metals
Disadvantages
• Difficult to Control
• High Temperature
• Slow and Uneven
Penetration
• Requires Long Exposure
Times
• Limited Packaging
Materials Available
• Not suitable to sterilize
fabrics and rubber

74. Types of Dry Heat
Sterilizers
•Gravity
Convection
•Mechanical
Convection

75. Gravity Convection Sterilizers
• Prone to air layering
which causes
temperatures to be
uneven

76. Mechanical Convection
Sterilizers
• Utilize a blower system
to insure even heating
thrughout the cycle.

77. CONVECTION
The process of heat transfer by the
circulation of currents from one area to
another

78. Dry Heat Cycle Phases
•Heat Up
•Exposure
•Cool Down

79. Items must be:
•Clean
•Dry
•Packaged

80. Preparation of Specialty Items

81. Oils and Powders
• Both Oils and Powders should be packaged less than 1
ounce and less that .25” deep
• The required sterilization temperature should be based on
manufacturer’s recommendations

82. Impregnated Gauze Strips
• Strips should be placed in a stainless steel container and
covered with petroleum jelly or other oil-based liquid
• Depth should not exceed .5”

83. Syringes and Needles
•Must be thoroughly Dry
•May be assembled

84. Instruments
• Must be thoroughly Dry
• May be assembled
• Ratchets and Boxlocks may
be closed
• Screws may be tightened as
necessary

85. Dry Heat Packaging Materials
• Heat Resistant Glass
• Stainless Steel Trays
• Cotton Muslin (if the chamber temperature does not
exceed 400 degrees F.)
• Aluminum Foil
• Nylon Films
• Certain Sterilization Containers (Check
Manufacturers’ Recommendations)

86. STERILIZATION
Quality Control

87. PROCESS INDICATOR
Devices intended for use with individual units
(for example, packs or containers) to
demonstrate that the unit has been exposed
to the sterilization process, and to distinguish
between processed and unprocessed units

88. External Chemical Indicator Tape
Before Processing After Processing

89. Examples of
Internal Chemical Indicators

90. Examples of
Internal Chemical Integrators

91. LOAD CONTROL
NUMBER
Label information on sterilization packages,
trays, and containers that identifies the
sterilizer, cycle run, and date of sterilization

92. Load Control Information*
Sterilizer
Number
Load
Number
Date Sterilized
*Must be placed on each item Sterilized
in the Central Service Department
S-1 L-5
05-03-07

93. Example of a Label Applicator Gun for
Load Control Information

94. JULIAN DATE
The Julian day or Julian day number (JDN) is
the number of days that have elapsed since
January 1st

95. Sterilization Logging Information
• Date and time of the sterilizer load control number
(sometimes called the lot number) which includes sterilizer
information.
• Specific items sterilized including:
• Quantity of items
• User (destination) department
• Complete item description
• Exposure time and temperature
• Sterilizer operator identification
• Results of biological testing (if applicable)
• Response of the CI placed in the BI test pack (if applicable)
• Results of the Bowie-Dick testing, if performed

96. Physical (Mechanical)
Monitoring
• Includes information from
time, temperature, and
pressure recorders
• Must be checked after
each load before the load
is released

97. BIOLOGICAL
INDICATORS (BIS)
Provide a measure of sterilization process
lethality

98. Examples of
Biological Indicators

99. BI Process Challenge Device (PCD)
Placement
BI Test
pack

100. Process Challenge
Devices
• Guidelines for Process
Challenge Devices are
discussed in detail on
pages 318 – 320 of the
text

101. BOWIE-DICK TESTS
Tests used to evaluate the efficacy of air
removal in dynamic air removal sterilizers

102. Examples of
Bowie-Dick (Air Removal) Tests

103. VALIDATION
Procedures used by equipment
manufacturers to obtain, record, and
interpret test results required to establish that
a process consistently produces a sterile
product

104. VERIFICATION
Procedures used by healthcare facilities to confirm
that the validation undertaken by the equipment
manufacturer is applicable to the specific setting
Specific information about verification
recommendations is discussed in detail on pages 321
– 322 of the text

105. SPECIAL HIGH TEMPERATURE
STERILIZATION
Concerns

106. D-VALUE
The amount of time required to kill
90% of the microorganisms present

107. Creutzfeldt-Jakob Disease
• Specific information
regarding procedures
for CJD are discussed
on pages 324 – 325 of
the text.

108. SOLUTION
PREPARATION
ANSI/AAMI ST79:2006, section 8.5.7 states:
“Primarily for personnel safety reasons,
inhospital preparation of and sterilization of
parenteral and irrigation solutions is
discouraged. When solutions are processed
in the hospital (i.e. emergency situations),
processing should be performed by trained
personnel”

109. Types of Solutions
Parental
Solutions
•Solutions that
are administered
to patients
intravenously
External
Solutions
•Solutions that are
normally used for
irrigating, topical
application, and
surgical use that
are given orally or
by inhalation

110. Flasking Technique
• Use only Borosilicate Glass Bottles
• Fill with freshly distilled water
• Use only vented closures that will allow
air and steam to escape
• Overfill by 3% - 5% to allow for
evaporation during sterilization