Ethylene Oxide

Gas
Sterilization

Sulaiman Alqarawneh

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 Outline
1. Ethylene oxide as sterilizing agent

2. Type of Ethylene oxide sterilizers:

-Pure gas sterilizer.
-Mixed gas sterilizer .
3. Aeration of sterilized materials.

4. Material sterilized by Ethylene oxide.

5. sterilization process monitoring

6-Advantage and disadvantages

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Sulaiman Alqarawneh
ETO Sterilization

ETO Stands for Ethylene Oxide

Sterilization.

Ethylene oxide sterilization is a type of

chemical process consisting of four
essential parameters :
gas concentration (450 to 1200 mg/l);
, humidity (40 to 80%), temperature
(30 to 60°C); and time (1 to 6 hours). .

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ETO Sterilization

Ethylene oxide is an alkylation agent that disrupts DNA

of microorganisms, which prevents them from
reproducing.

Replacement of a hydrogen atom with an alkyl group,

within cells prevents normal cellular metabolism and
replication.

ETO sterilization assures that a safe and sterile product

will be delivered to the market each and every time.

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Fact about ETO Gas
ETO gas is carcinogenic, explosive and
mutagenic.
Ethylene Oxide (ETO) is a common gas
used for low temperature sterilization.
It is a colorless, poisonous gas that attacks
the cellular proteins and nucleic acids of
microorganisms.

It is most commonly used to sterilize

instruments with long lumens such as
endoscopes and all materials that have to
be sterilized but cannot withstand higher
temperature.
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Sulaiman Alqarawneh
Fact about ETO Gas

ETO process temperatures from30- 60°C are used.

A lower temperature results in a less efficient process

which leads to a longer exposure time.

Note: EtO sterilization should be used only when

another method is not appropriate.

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ETO Sterilizer

ETO Sterilizer is equipment,

which facilitate ETO Sterilization
process.
ETO Sterilizers are available in
various capacities from 0.45m3
to 44m3 volumetric capacities
Front View of ETO Sterilizer
to carry out ETO Sterilization.

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Type of Ethylene oxide sterilizers

- Pure gas sterilizer.

- Mixed gas sterilizer .

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 Pure gas sterilizer.
Pure EtO is inflammable and explosive.
EtO gas is colorless, is heavier than air, has an
ethereal odor, is detectable between 230 to 700
ppm.,
and is soluble in water and in the majority of
solvents. The characteristics of EtO make the
sterilization of materials in special, controlled
conditions possible.

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Mixed gas sterilizer .

Ethylene oxide and its mixtures with carbon dioxide are used
in the biomedical industry for producing plastic-disposable-
sterile equipment for hemodialysis, heart surgery, auto
transfusion, plasmapheresis, blood filtration, etc.
The sterilization rate depends on temperature, length of
treatment, gas concentration and humidity.
For maximum sterilization purposes, it is possible to work in
concentrations from 400 to 1000 mg/l.
For each use with a different purpose, experimental tests
need to be carried out each time in order to establish an
appropriate working cycle.

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Mixed gas sterilizer .
Ethylene oxide is also extremely effective against
microorganisms, spores (typical form five to ten times
stronger than common bacteria), moulds and yeasts and
can inactivate viruses.

The use of atmospheres based on ethylene oxide and

carbon dioxide is the most common technology used in
the sterilization of objects changed by heat or of
disposable products, for the following reasons:
they are very effective

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 Mixed gas sterilizer .

They have good diffusion through the packaging material

They are not absorbed by the product
Technical problems such as changes in material resistance,
deformation and toxicity are not a factor
They do not cause aesthetic/functional problems
(yellowing, opacification).

Most of the time, it is mixed with Nitrogen or CO2.

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 ETO Sterilization Cycle

There are at least three stages in a typical EtO

sterilization cycle:

Preconditioning

Sterilization

Aeration (Degassing)

Cycle time is usually more than 14 hours.

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 Preconditioning
prepares the chamber environment to meet the ideal
conditions for temperature, pressure and humidity.
First air is removed from the chamber to allow for gas
penetration.
A leakage test is performed, to ensure that staff and
environment are safe. Next, some steam is injected into
the chamber and humidifies the load, since EtO is only
effective in a humid environment.
The chamber is heated by either steam or hot water which
is present in the jacket.
Normally the jacket is kept at the same temperature 24/7
to minimize temperature fluctuations.
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 The second stage is the actual
sterilization process.

The EtO enters the chamber via evaporation with a

certain amount of steam to keep the humidity level up as
well as to make sure the EtO is reaching all parts of the
load.
When the required concentration in the chamber and
load is achieved the actual sterilization stage starts.
The lower the gas concentration in the chamber the
longer is the sterilization time.

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 The second stage is the actual
sterilization process.

As EtO is absorbed by many kinds of plastic materials it is

important to keep the concentration at the right level.

To achieve this EtO is sometimes added to the chamber

after a while.

It is of major importance to ensure the appropriate

concentration level of EtO in the chamber to achieve
effective and safe sterilization.

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Aeration (Degassing)
Aeration is the most important and longest part of the EtO
sterilization cycle.

As mentioned, materials such as plastics and rubbers absorb

gas and if applied to patients, the toxic gas could damage
their body tissue! For this reason it is very important to have
an excessive aeration stage to remove any remaining EtO gas
and to allow absorbed gas to evaporate again from the
sterilized items.

This is done by circulating HEPA filtered air over the load at a

temperature of 30°C to 50°C
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Aeration (Degassing)

A commonly used time period for this aeration treatment is

48 hours which results in a very slow instrument
turnaround.
A special infrastructure is required, with gas tight
ventilation piping to the roof top or to a catalyzer.

The sterilizer cannot use the hospital's ventilation system

because it is too dangerous. The special ventilation piping
has to be tested for gas leaks all the way as this is the only
way to minimize the risks.

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Materials Sterilized by Ethylene oxide
❑ Paper
❑ Leather
❑ Wood
❑ Metal
❑ Rubber products as well as plastics
In medicine, Its used to sterilize:
❑ Catheters artificial heart valve
❑ Heart-lung machine components
❑ Multi-lumen tubing products
❑ Stents
❑ Wound care dressings

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Ethylene oxide sterilization
processes monitoring
Monitoring with biological indicators that are
composed of the microorganism Bacillus atrophaeus,
usually inoculated onto a 1.5 X 0.25 inch paper
carrier.
The biological indicators are placed throughout the
sterilizer load and subjected to the sterilization
process. After the process, the biological indicators
are removed from the load and forwarded to the
testing laboratory, where they are placed into a
special growth medium and subjected to ideal growth
conditions for 7 days
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 Chemical Indicator
Chemical Indicator
Initial Color: Purple
Signal Color: Green
Chemical Indicator Inks contain no lead or other toxic
heavy metals

the chemical indicator will transition from purple to

green. The transition color may varying depending on
the load configuration, length and conditions of
exposure.
A color transition from purple to a shade of green
provides indication of exposure to EO.
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 Advantages of ETO Sterilization
1- Low temperature.

2- High efficiency – destroys micro-

organisms including resistant spores.

3- Large sterilizing volume/ chamber

capacity.

4- Non corrosive to: plastic, metal and

rubber materials

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Disadvantages of ETO Sterilization
- Excessively Long cycle
- Safety concerns - carcinogenic to humans

- Toxicity issues - toxic residues on surgical

instruments and tubing

- Not recommended for flexible scope

- ETO is flammable
- Requires special room conditions, safety
equipment and separate ventilation system

- Relatively high annual costs for

maintenance, servicing and consumables.
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 Thank
You

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Sulaiman Alqarawneh