STERILIZATION

B Y U BA I D U L L A H N A W A B
S U RG IC A L D I S C I P L I N E
KM U I PM S
 Introduction

Sterilization:
Sterilization is the process by which all
microorganisms including endospores are killed.
Sterilizer is an equipment which is used for
sterilization. The instrument is said to be sterile after
processing.
Sterilization cycle is the time required for the
processing __ sterilization
 RELIABILITY PARAMETERS FOR
STERILIZATION

Product associated parameters:

Bioburden
degree of contamination, how much
Bioresistance
sensitivity and product stability
Biostate
nutritional, physical, reproductive phase of
microorganisms.
Density
factors affecting penetration and evacuation of the agent
Process associated parameters
Temperature
Humidity/hydration/moisture
Time
Purity of agent
Saturation/penetration/contact
Capacity of sterilizer and position of items
 METHODS OF STERILIZATION

Thermal (physical) sterilization

 Steam under pressure
 Hot air / dry heat

Chemical sterilization
 Ethylene oxide gas

 Formaldehyde gas & solution

 H2O2 plasma/ vapor

 Ozone gas

 Acetic acid sol

 Glutaraldehyde sol

 Paracetic acid 0.2 % sol

 Hypochlorous acid

Radiation sterilization
 Microwave (non ionizing)

 X ray (ionizing)
 MONITORING OF STERILIZATION
CYCLE

Indicators are used for monitoring the validate

exposure sterility conditions/ parameters of
instruments of sterilization process.
Types of indicators:
Mechanical indicators
Chemical indicators
Biologic indicators
Mechanical indicators:
The sterilizers have gauges, thermometers, timers, recorders,
alarm system and other devices which monitors their
function.
Chemical indicators:
Class Ι: a striped tap (autoclave tap) is used externally on the
processed pack that changes color after exposure to sterilizer.
Class ΙΙ: autoclave test pack (bowie dick test) is used
internally in the autoclave chamber which test the air removal
inside the chambers. If the test pack color changes uniformly,
no air is left.
Class 3: single variable indicator:
It is one critical variable in the sterilization process
e.g. chemical pellet (solid chemicals in tube melts at
specific temp) which is used to determine that a
specific tem is achieved or not.
Class 4 multi variable indicators:
Paper strips is printed with chemical indicators that
displays two or more changes in response to
sterilization. Commonly used in dry heat cycle.
Class 5 chemical integrator strip that react in
the same way as a biologic indicator in the presence
of time, temperature, and steam penetration.
Class 6 emulating indicator: responds to all
critical variables during the use of a sterilization
process challenge pack. They are not intended to
replace biologic indicators.
Biological indicators:
Pre formed resistant endospores are used in self
contained system e.g. dry endospore printed strip or
sealed vials or ampules endospores in suspension.
The BIs are exposed or immersed in sterilant (agents
which are used for sterilization) and display a change
in color.
After sterilization the BIs is incubated for growth. If
no growth or survive, sterilization has occurred.
Gram positive bacterial endospores used for
BIs:
Geobacillus stearothermophilus
Bacillus atrophaeus
B. atrophaeus
 Thermal (physical) sterilization

Heat is dependable physical agent for the

destruction of all forms of microbial life.
It may be moist (steam) or dry.
(1) steam under pressure sterilization
(2) dry heat sterilization
 Steam under pressure (moist heat sterilization)

In steam under pressure sterilization, the pressure of

the steam increase the temperature of steam for the
thermal destruction of microbial life.
Moist heat in the form of steam under pressure
causes the denaturation and coagulation of protein
or enzyme within the cells.
autoclave
 Wall and valves of autoclave

Wall: composed of aluminum.

Pressure vent: surplus pressure is evacuated
Pressure release: to release the steam
Safety valve: the safety valve burst when pressure
valve compromised
Pressure gauge: indicate the parameters

Pre-vacuum and gravity displacement sterilizer?

 Parameters for sterilization

The vegetative form of most microorganisms are

killed in a few minutes at temperature ranging from
130-150 F (54-65 C).
However, bacterial endospores will withstand a
temperature of 240 F (115C) for more than 3 hrs.
No living thing can survive direct exposure to
saturated steam at 250 F (121 C) for longer than 15
minutes.
Gravity displacement sterilizer:
Temp=250-254 F (121-123 C)
Time= 15-30minutes (minimum time is 15 mints)
pressure= 15-18 psi
For CTJ= temp=270-274 (132-134 C), time is 1 hr.
Pre vacuum sterilizer:
Temp=270-286 F (132-141C)
Time=4 minutes
Pressure= 27 psi
For CTJ=temp=270-286 F, time is 18 minutes
 Dry heat sterilization

Dry heat in the form of hot air is used primarily to

sterilize anhydrous oils, petroleum products, and talc,
which steam and ethylene oxide gas cannot penetrate.
the sterilizer is loaded according to the manufacturer’s
recommendations:
• 6 minutes at 400° F (204° C), unwrapped
• 12 minutes at 375° F (190.5° C), wrapped
• 1 hour at 340° F (171° C), wrapped or unwrapped
• 2 hours at 320° F (160° C), wrapped or unwrapped
• 3 hours at 285° F (140° C), wrapped or unwrapped
• 6 hours at 250° F (121° C), wrapped or unwrapped
 Ethylene Oxide Gas Sterilization

Ethylene oxide gas is used to sterilize items that are sensitive to heat or
moisture. EO or EtO is a chemical alkylating agent that kills
microorganisms (including endospores) by interfering with the normal
metabolism of protein and reproductive processes, resulting in cell death.
EO is highly flammable and explosive in air and therefore
must be used in an explosion-proof sterilizing chamber in a controlled
environment.
EO gas sterilization depends on four parameters:
Concentration of gas
 100% EO

 CFC-12

 EO/CO2 10/90

Temperature 85° F to 145° F (29° C-63° C)

Humidity 30% to 80%
Time (dependable)
Disadvantages:
Longer time
Flammable
Long-term exposure to EO is known to be a potential
occupational carcinogen, causing leukemia. It is also a
mutagen, causing spontaneous abortion, genetic defects,
chromosomal damage, and neurologic dysfunction.
EO gas is vented from the sterilizer to the outside
atmosphere to avoid personnel exposure.
To purge residual gas, air is admitted into the chamber
at the end of the sterilization cycle. In sterilizers with a
pulse-purge cycle, the air is admitted and immediately
removed as many as six times in 30 minutes.
 Hydrogen Peroxide Plasma Sterilization

Hydrogen peroxide (H2O2) can be activated to create

a reactive plasma.
Free radicals of the hydrogen peroxide in the cloud
interact with cell membranes, enzymes, or nucleic
acids to disrupt the life functions of microorganisms.
The processing time ranges between 35 and 75
minutes.
A low temperature allows the safe sterilization of
some heat-sensitive items.
The reactive particles in the plasma are maintained at
104° F (40° C).
Question?
 ASSEMBLY OF INSTRUMENTS SETS

The soiled instruments are delivered by surgical

personnel to decontamination area of CPD to prevent
the dispersion of microorganisms.
The CS personnel should wear personal protective
equipment (PPE) and is not allowed to enter the sterile
area.
The sharp and disposable instruments should be
discarded in puncture proof container.
After the decontamination, the clean instruments
should be transferred to set assembly room where the
instruments are organize into trays according to tray
inventory sheets (count record).
Heavy instruments such as retractors are placed in the bottom of the
tray.
Open the hinges and box locks on all hinged instruments.
Place the delicate and sharp instruments on the top of other instruments.
The concave or cuffed shaped surfaced instruments are placed so that the
cuffed surface down to avoid water collection.
All detachable instruments should be dissemble into parts.
Wrap the tray in a rigid container.
The assembled or organized instruments in a tray then wrapped or
packed, with a copy of count sheet, into a closed container for
sterilization.
Label the instruments with indicators so that the pack is ready for
sterilization.
The sterilizer is operated by the same CS personnel working in the CPD.
 PACKAGING INSTRUMENTS AND OTHER
ITEMS FOR STERILIZATION

The purpose of packaging is to protect the items from

contamination and maintain sterility until it is opened.
The instruments should be packaged in such a way to allow
adequate exposure/ contact to the sterilant.
Allow the release of sterilant at the end of the exposure period.
A quality packaging material is used to avoid rupture or cracks
in varying conditions.
The packaging material should be impermeable for creating a
barrier for microorganisms, dust particles, moisture etc. after
sterilization.
Packaged should be wrapped with woven or non woven
materials sequentially in two layers.
The sterilization packaging is classified by the FDA.
And only the approved packages should be used.
Different types of packaging is used for different
types of sterilization.
 PACKAGING MATERIALS

Woven fabrics (muslin or linen):

This type of fabric is not moisture resistant and is used in a double
thickness.
Woven textiles have 140 threads per square inch.
Two pieces are sewn together on the edges only.
The fabric should be stored at room temp 64-72 F or 18-22 C with relative
humidity of 35 – 70 %.
Non woven fabrics:
Combination of cellulose, rayon, nylon or other combination may be.
Lightweight is used in four thicknesses; medium weight is the most
economical for wrapping items in two thicknesses; and heavy-duty weight
is used when a single wrap is used for wrapping supplies for sterilization.
Nonwoven fabrics provide an excellent barrier against microorganisms and
moisture during storage after sterilization.
Peel packs or peel pouches:
Peel pouches is the combination of paper at one side and plastic
film at the other side commonly used for packaging materials.
The paper side of the pouch allow air removal and for the
sterilant to enter the pouch.
The plastic film is used for direct visualization of the items and
chemical indicators.
It is used to wrapped single, odd shaped and small items.
Before use the pouches should be inspected for tears or any other
damage that has been occurred during transport or handling.
The pouches are open at one end to insert instruments.
The peel pouches after securing the contents, are heat sealed or
manually self sealed or sealed with masking taps.
The peel pouches are placed on its side in the tray
when processing. Paper side down may also be used.
However, plastic side down impede the flow of steam
sterilization and may cause condensate to pool inside
the pouch resulting in a wet pack.
Sealants and labeling:
The sealants are used to enclose or seal the open end
of peel pouches or wrapped items.
Peel pouches are sealed with heat sealed or manually
self sealed having an indicators area which changes
color.
A tan masking tape is a steam sensitive tape which
changes to dark stripes after exposure to sterility
conditions.
Light green masking taps is a gas sensitive tape which
reveals dark color after sterility parameters.
Wrapped trays:
The instruments are placed in open trays with mesh or
perforated bottoms.
Absorbent towels or foam should be placed in the tray
for unwrapped instruments to absorb condensate and
protect instruments from snagging in the perforations.
Trays are sequentially double wrapped in woven or non
woven wrappers.
They must be allowed to cool and dry at the end of
sterilization before handling.
INTEGRITY OF PACKAGING MATERIAL AND
HANDLING

Integrity
 The consistency, rules and principles that are followed all
the times of packaging material and handling.
Packaging materials
 The items are wrapped in woven / non-woven textiles or
enclose in peel pouches to secure the contents.
The word handling refers to the
 Using, management, holding, touch, manipulation of
something.
 PACKAGING MATERIALS

What is the purpose of packaging materials?

 To secure the contents.
 To maintain sterility.

 To allow sterilant penetration.

 To handle items easy and safe.
 For convenience & information.

 To prolong the shelf life of items.

 To paste/ kept labels and indicators
 PACKAGING INSTRUMENTS

When the instruments are packaged ?

The instruments are packaged after;
 Cleaning
 Manual cleaning
 Mechanical cleaning
 Ultrasonic cleaning
 Prerinsing/presoaking
 Thorough cleaning or return-to-use cleaning

 In short words the instruments are packed before

sterilization.
 PACKAGING INSTRUMENTS

What materials are used for packaging?

 Woven textile or woven fabrics:

 It is reusable fabric commonly referred as muslin or linen
 It absorb condensate or moisture.
 It is used in a double thickness
 Non woven textile or fabric:
 Combination of cellulose, rayon or nylon
 Moisture or condensate resistant
 It is disposable
 Peel pouches:
 It is composed of paper at one side and plastic film at other side.
The open end then sealed after the enclose of contents.
 Conti…

How to place the peel pouches in tray for

processing?
 The peel pouches are placed on its side in tray or container
 Inclusion of paper side down may also validable.

 The paper side of the pouch allow air removal and for the
sterilant to enter the pouch.
 Keep in mind that plastic side down impede the steam
sterilization and condensate to pool inside the pouch
resulting in a wet pack.
 Conti…

Storage of packaged materials:

 Sterile packaged materials should be stored in a controlled
environment to help reduce the potential for contamination.
 Approximately 24 C (75 F) temp and humidity should not be
exceed than 70 % with 4 ACH.
 The storage area should be separated from decontaminated
area where positive pressure can be easily maintained to
avoid the inward flow of air from surrounding.
 Conti…

Shelf life of packaged materials:

 Shelf life is the period of time during which a sterile
package is considered safe to use.
 The shelf life of sterile packaged materials depend on the
following factors:
 Quality of packaging material
 Storage conditions
 Transport conditions
 Handling of sterile packaged items
 SAFETY CONSIDERATION REGARDING
INTEGRITY OF PACKAGING MATERIALS

The items are considered sterile unless the integrity

of the packaging is compromised.
Concerns include:
 Accidental puncture, tear, rupture of package
 Squeezing and crushing of package
 Dirt, dust and debris
 Wetting of sterile package
 Conti…
 ACCIDENTAL PUNCTURE, TEAR, RUPTURE OF
PACKAGE:
Physical damage or breakdown of packaging
materials interrupt the sterility of materials.
The relies include:
 Wrong distribution of instruments during packaging
 Handling manipulation
 Type of packaging
 CS personnel credentials
 Improper inspection
 Conti…

Squeezing and crushing of package

The squeezing and crushing of packaging materials
compromise the integrity of packaged items.
The unsterile air draws in to the package and
contaminate the contents and the sterility is no
longer maintained.
Packages wrapped in woven textiles are moisture
sensitive therefore, should be handle carefully.
 Conti…

Wetting of sterile package

The sterility is disrupted due to wet or condensate.
The concerns include:
 Handling with wet hands
 Handling with soiled gloves
 Placing the package on wet surface
 Excess humidity causes the package to wet
 Plastic side down peel pouches in steam sterilizer.
 Integrity and handling

INTEGRITY of:
 Woven and non woven fabrics

 Heat sealed and self sealed pouches

 Integrity and handling

Integrity of woven and non-woven textiles;

Woven type of fabric is not moisture resistant and is
used in a double thickness.
Nonwoven fabrics provide an excellent barrier
against microorganisms and moisture during storage
after sterilization.

From the above discussion it is clear that non

woven textiles and plastic materials provide more
integrity than woven textiles.
 Integrity and handling

Heat sealed and self sealed pouches

The open end of peel pouches is sealed after the enclosure of
items to secure the contents.
The sealants are:
 Heat seal

 Self seal

 Masking tape seal

Heat seal caution (superheating):

 Different materials require different heat or temperature ranges.

 Be sure to avoid creases or gaps at the edges when sealed with

heat to avoid the entry of microorganism and unsterile air.
 DUST COVER

Dust cover protect the sterile package and make more

secure from dust, dirt, lint, moisture and vermin
during storage.
It is used to enclose the package materials should be 2
to 3 mm thick.
It protect the integrity of sterile package.
The dust cover is manually self sealed.
 STORAGE CONDITIONS

The following guidelines are helpful in maintaining

the sterility of package during storage:
Cleaning procedures
 The storage area should be clean from dust, dirt etc.
transport carts & shipping vehicles are not allowed in
storage area.
 The CS personnel working in the decontamination area
is also not allowed to enter the sterile storage area
 STORAGE CONDITIONS

Parameters or conditions
 The sterile packaged materials should kept under conditions upto
validate level.
 Warm environment and high humidity cause moisture to
condensate resulting in a wet pack.
 The temperature required for storage area is 75 F (24 C) & a
relative humidity between 30- 70 %.
 Four ACH are recommended by AAMI (Association for the
Advancement of Medical Instrumentation).
 After sterilization, the packaged materials allow to cool at room
temperature to avoid a wet pack.
 STORAGE CONDITIONS

Alignment, distribution and organization of

sterile packaged materials in storage area:
 Heavy materials are placed at the bottom and light
materials are placed at the top.
 Peel pouches should be stored on their sides to minimize
the pressure from items stacked on top of them.
 STORAGE CONDITIONS

Shelving storage:
 The open shelves should be at least 18 inch (46 cm) below
the ceiling or sprinkler heads and 8-10 inch (20-250) above
the floor. The shelves should be 2 inches away from wall.
 Closed cupboards are more preferred.
 ROTATION OF SUPPLIES

Some materials are used on daily bases while seldom

instruments are rarely used.
The seldom instruments are kept for prolong periods.
Older supplies/ packages should be use first.

Acronym :
FIFO __ First In / First Out.