Professional Documents
Culture Documents
Autoclaves
Autoclaves
Autoclaves
All surgical instruments that are in touch with open wounds or enter the
body of a patient must be sterile. Therefore, all surgical instruments and
materials have to be sterilised before surgery. The machine which does the
sterilisation is called autoclave or steriliser. If sterilisation does not
happen or happens insufficiently, life-threatening infections are the result.
For this reason the autoclave is one of the most important pieces of
equipment in a hospital.
The medical steam autoclave is a device that uses pressurised, high
temperature steam to sterilise medical instruments. Although there are still
other methods of sterilisation e.g. dry heat, gas (Ethylene Oxide) or gamma
radiation, the sterilisation with hot steam is the most common method. The
usage is simple, rapid, cost effective and environment friendly. The following
article refers to the steam autoclave.
Sterilisation
Sterilisation is the elimination of all transmissible micro organism, bacteria,
viruses and fungi from the surface of an instrument. This is different from
disinfection, where only organisms are removed by a disinfectant and are
not completely eliminated.
In general, any instrument that enters the body must be sterilised. This
includes all surgical instruments, implants, catheters, syringes, needles,
dressings and others.
Proper sterilisation of instruments is crucial in preventing HIV transmission.
Sterilisation is possible with hot air, chemicals or radiation, but the most
common method is the use of hot steam, which kills all organisms. This
method is easy and cheap to realise.
For a steam sterilisation temperatures above 110°C are needed, which
requires the steam to be applied in a pressure chamber. The sterilisation
time depends on the temperature. The higher the temperature the faster the
instruments get sterile.
Types of autoclaves
All steam autoclaves have a metal chamber to withstand the high pressure
and the temperature. A massive door or lid which is locked during operation
keeps the chamber closed. The chamber is heated by an electric heating
element. In places without electricity supply autoclaves heated up by gas or
fuel are common.
To ensure that an autoclave works correctly, the machine has a temperature
and/or a pressure gauge and often an integrated timer.
Modern autoclaves are all electronically controlled. The control unit controls
temperature, pressure and time and monitors all safety functions.
Hospital autoclaves are available with chamber capacities from 5 l to 900 l.
The smallest and simplest ones work manually and are heated up by a
normal electric or gas stove. The big stationary autoclaves are fully
automatically controlled and need three-phase-power supply and a water
supply installation.
Table-top
Table top autoclaves have a
capacity of 20-80 l. Although it has just small capacity, the table-top is the
most common autoclave. It is found where surgical instruments are needed:
E.g. in maternity wards, laboratories and at the dentist.
Modern table-top autoclaves are a fully automatically controlled, and often
come with a vacuum pump and a drying program for drying the goods after
sterilisation.
Table-tops are designed for front loading use and provide different trays for
surgical instruments. They also have a safety lock for the door and a water
reservoir.
Stationary
Important: Water and steam temperatures of 121°C or 134°C can only be reached
under pressure.
Note: We technicians talk about the gauge pressure, the technical pressure.
Working principle
The working principle of steam autoclaves is always the same. The difference
is the control. Manual autoclaves are simple and robust but the user has
always to be present. Fully electronic controlled autoclaves are easy to use
but more difficult to repair.
Working principle of a simple autoclave (pressure type, vertical)
Water is heated up in the chamber. At 100°C steam develops and after a
short time the pressure increases, the boiling point of the water rises and so
does the temperature (heating phase).
When the predefined pressure or temperature is reached the heating
element is switched off, either by a thermostat or a pressure switch. In
electronic controlled autoclaves a pressure or a temperature sensor delivers
a signal to the control board.
At this point the sterilisation phase begins. Then the temperature drops a
bit and the heating element is switched on again. In this way the
temperature is kept stable. At the same time a timer gets started and after
the set time the autoclave switches off completely. The sterilisation process
is now completed (drying phase), the outlet valve opens and releases the
steam. The sterilisation goods remain a little longer in the chamber and the
radiant heat from the chamber dries the items.
Important: The sterilisation time begins only when the sterilisation temperature
(121°C or 134°C) is reached.
Vacuum pump
Unfortunately the sterilisation process is not that easy. In practice the items
to be sterilised are not packed separately but in packages wrapped in
clothes. When the packages are packed too tight, the steam cannot
penetrate everywhere. Zones of colder air come into being and the items do
not get sterile.
Furthermore some surgical instruments consist of individual parts. In the
joints and spaces between the parts little air bubbles with cool air remain
and prevent the hot steam to penetrate (e.g. the joints of scissors) and the
items will not get sterile.
Simple autoclaves which just use the steam to press the cold air out of the
chamber (gravity displacement) have problems to reach the cold air zones in
the packs between the instruments. Here an additional vacuum pump helps.
Before the sterilisation process begins, the vacuum pump sucks the air out
of the packs and the insulating air bubbles disappear (pre-vacuum). Then
the sterilisation process is started by the control unit.
Later when the autoclave has finish the sterilisation, the vacuum pump is
used again to suck out the steam before the door can be opened (post-
vacuum). In this way the packages get perfectly dry.
The pressure again is 0 bar. The valve closes and the water heater starts
heating. The temperature in the closed chamber rises slowly. In the
meantime the vacuum pump creates some more vacuums (air
removal phase) which suck the trapped air out of the sterilisation packs.
After some minutes the boiling point of the water is reached and the vacuum
pump switches off completely. Now steam is created. The steam gets more
and creates a pressure. Under pressure the boiling point start to shift and
the temperature rises (heating phase). After some more minutes the pre-
set temperature or pressure is reached and the heater is switched off.
Now the sterilisation period begins and the timer starts. The pre-set time
which is related to the temperature (20 minutes at 121° or 3 minutes at
134°) is counted down. A temperature or pressure sensor controls the whole
process and lets the heater restart when the temperature drops
(sterilisation phase).
When the sterilisation process is finished an outlet valve opens and steam is
released from the chamber, condenses in a special condenser and the hot
water gets back into the reservoir. The temperature in the chamber
decreases. Now the vacuum pump supports the drying process by sucking
the steam out of the chamber (drying phase).
Sometimes a special chamber heater is switched on additionally in order to
improve the drying process.
Water quality
The water quality is very important for the usage of autoclaves. In principle
only distilled water or de-mineralised water should be used because the
water has to be pure and free of any minerals.
But often normal tap water is use, which causes serious problems. The tap
water leaves deposits on the components of the autoclave and the
sterilisation items. Surfaces of surgical instruments get destroyed after some
time and valves and the tubing in the autoclave get blocked or damaged. On
heating elements a layer of lime is formed which gets thicker and thicker.
One day the heating element cannot conduct the heat sufficiently and the
heating element will burn out.
User manual
The usage of the autoclave has to be followed strictly according the user
manual. One copy of the user manual has to present in the department
where the autoclave is operating and one should be available in the
workshop.
It is also a good idea to create a 'Quick User Chart', a one-page to-do-table
with the most important information for the operator. Additionally, the
phone number of the hospital technician should not be missing. This
instruction can be laminated in plastic and hang up close to the autoclave.
Bowie-Dick-test
We technicians check the temperature and the sterilisation time to ensure
that the autoclave meets the technical conditions for the sterilisation
process.
A performance test does more, it shows if the whole sterilisation process
was successful, if the packages were packed correctly and the autoclave not
overfilled.
Such a test is performed with indicator strips or tape and is called Bowie-
Dick-test.
According to the international standards Bowie-Dick-test has to be done
every day by the autoclave operator.
For this purpose a test strip is placed in the centre of the load and the
sterilisation cycle is started. After sterilisation a colour change indicates
whether the steriliser works correctly or not. A failed test can be the result
of a defect autoclave or, and this is more likely, of an overfilled or wrongly
packed autoclave.
When a Bowie-Dick-test fails and the operator does not find a packing
problem, the hospital technician has to come to do a technical check. Then
the sterilisation temperature and the time have to be measured.
To do a Bowie-Dick-test in the workshop after maintenance or repair is
pointless because we run the autoclave empty and a Bowie-Dick-test would
always pass.
In addition to the daily Bowie-Dick-test, a more precise test with biological
indicators should be done twice a year. These indicators have to be sent for
analysing to a certified laboratory.
Validation
An autoclave validation goes even further. A validation monitors the whole
sterilisation process from the cleaning and packing to the sterilisation
process and unpacking. It also covers technical issues like measuring the
sterilisation temperature but mainly the organisational aspects.
For validation national or international standards apply.
Steam-pulsing
Pressure cooker types and vertical autoclaves without a vacuum pump have
problems to remove the air of porous sterilisation goods. In this case
some experts suggest to use the steam-pulsing technique in order to
improve the sterilisation result.
Therefore, the air-removal valve is opened and closed briefly for a few times
at the beginning of the sterilisation phase. These pressure pulses flushes out
the trapped air in the porous sterilisation goods. The sterilisation phase has
of course to be extended by a few minutes.
This method really works fine for sterilisation of porous sterilisation goods.
But to make it clear: It is an improvement for an otherwise functioning
procedure.
The steam-pulsing method is no solution for wrong usage and it cannot
replace the procedure described in the user manual. Instead of
implementing another (complicated) procedure, make sure that the operator
first follows the instructions in the user manual.
Air-removal valve
Is opened manually when the sterilisation process is finished. It releases the
steam out of the chamber. This can be done by opening a mechanical valve
or by a solenoid when pushing a switch.
Safety valve
The safety valve opens and releases the pressure out of the vessel if the
pressure control valve fails and the pressure gets too high.
With pulling the safety valve also the steam pulse can be applied (↑Steam-
pulsing)
Pressure gauge
The pressure gauge shows the pressure in the vessel but is not really
needed when a thermometer is built in.
Pressure vessel
The high pressure chamber is made out of stainless steel. It contains the
sterilisation goods.
Heating element
The heating element (sometimes three elements for a three-phases power
supply) heats up the water. It is important that it is always covered with
water. A dry heating element will burn out within seconds.
Drain valve
It is used to drain remaining water from the chamber after sterilisation and
during cleaning.
Variations
Some vertical autoclaves are double walled where the sterilisation goods
are not placed directly over the heated water in the upstream steam but in
another chamber. This inner chamber is placed in such a way, that the
steam can only enter from above. That helps to achieve a more
homogeneous and safer sterilisation result.
Because the water level is no more visible in a double walled autoclave, this
type has a gauge glass that shows the water level inside the outer chamber.
Most of the autoclaves have an integrated timer. The timer starts when the
sterilisation temperature is reached and switches off the heating elements
when the sterilisation time is over. The timer is often a mechanical one,
driven by a little motor. In modern autoclaves the timer is a small electronic
circuit.
The valve 2 opens and water runs from the reservoir 1 through a
filter 3 into the chamber 4. When the water level reaches the level
sensor 6 the valve closes and the heater switches on. After a while, steam is
generated. The steam rises and pushes the cooler air through valve 9 and
the condenser 10 out of the chamber. When the temperature reaches the
boiling point (measured by the temperature sensor 7), the outlet
valve 9 closes. Then the pressure in the chamber rises (shown by the
pressure gauge 8) as well as the temperature. When the sterilisation
temperature is reached (sensor 7), the heating element switches off. If the
temperature control fails and the pressure gets too high, the pressure is
released by safety valve 11. For cleaning and servicing, the water can be
drained by the manual valve 12.
In addition, modern table top autoclaves provide more safety features like a
door lock and an internal water tester and most of all a suction pump.
Mechanical sensors and meters are replaced by electronic ones. An
electronic board or a microprocessor controls and monitors the sterilisation
process.
1 Heating element
2 Water inlet
3 Level sensor
4 Steam to reservoir
5 Test port for external
thermometer
6 Safety valve
7 Sensor for thermometer
8 Pressure meter
9 Sensor for temperature
control
Temperature sensor
The actual temperature in the chamber is measured by a temperature
sensor. The sensor delivers the measurement to the control unit. Here the
actual and the pre-set temperature are compared and a control voltage for
switching the heating elements is created.
Steam valve
After the sterilisation phase, the release valve (outlet valve) opens. Steam
gets out of the chamber, flows through a condenser and gets back as hot
water into the reservoir.
Safety valve
The safety valve is designed to release steam in case the chamber pressure
is increasing beyond the normal range due to a fault in the control elements.
Without safety valve the chamber would burst with catastrophic
consequences.
Variations
Modern table top autoclaves always provide a vacuum pump. Whenever
a vacuum pump is used, an additional ventilation valve with a bacterial
filter is needed.
Often table top autoclaves also have an internal water quality tester.
Before the distilled water is led into the chamber, the water conductivity is
automatically tested. When the quality is not good enough, the autoclave
cannot be started.
When the inlet valve 1 is open, hot steam from the external boiler enters the
jacket 2 of the autoclave. The chamber gets preheated. The pressure gauge
shows 3 the jacket pressure. When valve 4 is opened, the steam gets into
the chamber. The colder air escapes through the open valve 6. The valve is
a temperature controlled one-way valve. The valve closes when the steam is
hot enough. Now the pressure rises until it is as high as the inlet pressure.
The chamber pressure is shown by the pressure gauge 8 and the
temperature by the thermometer 5. It is placed at the bottom of the
chamber, where the lowest temperature is. When the sterilisation time is
over, the inlet valve has to be closed and the outlet valve 7 opened. Steam
escapes through the drainage pipe. The pressure and the temperature in the
chamber decrease but the jacket is still under hot steam pressure. This
supports drying the load. After a while the steam from the jacket can also be
released by opening valve 4 or it can be kept if another load has to be
sterilised.
The safety valve 9 opens when the steam pressure is too high. In principle
this valve is not needed because the boiler already contains one and the
pressure in jacket and chamber cannot get higher than the pressure in the
boiler.
Variations
Simple, manually controlled autoclaves are still widespread. They are robust
and relatively easy to repair. Spare parts can be found in every larger city.
Modern stationary autoclaves are fully electronically controlled. There
are no more manual valves and also the instruments for pressure and
temperature are often digital ones.
Also in stationary autoclaves a vacuum pump provides a better sterilisation
result and has already become standard. Wherever a vacuum pump is used,
an additional ventilation valve with a bacterial filter is needed to ensure only
uncontaminated air can enter the chamber when equalizing the pressure at
the end of the cycle.
Maintenance
Beside the routine checks by the user personnel, autoclaves should be
maintained at least once a year by the technicians of the hospital workshop.
Many manufactures suggest even semi-annual maintenance according to
their guidelines.
The maintenance of an autoclave covers the cleaning from inside and
outside, a functional check and the control of the temperature. A calibration
has to be done if the temperature check was not successful.
Very often a service manual is needed to set the autoclave in a defined
service mode and to find the calibration points for the temperature and the
display.
Note: Be very careful while doing service on an autoclave. Some older autoclaves have
only little or no heat shielding around the chamber. The chamber, tubes and valves get very
hot.
Needed tools
Beside the standard tools you need a calibrated thermometer with an
external sensor. Only with such a reference thermometer are you allowed to
check and adjust the temperature. The built-in (digital) thermometer of the
autoclave cannot be taken for the temperature check. When the display of
the autoclave does not show the correct temperature you do not really know
if the temperature is wrong or the thermometer itself shows a wrong result.
For some models it is useful to have a 2 mm rod sensor which can be
inserted in a special test port.
More under ↓Calibration.
A pressure meter is not needed, even if the manufacturer recommends this.
Stay with the temperature measurement. It is safer, more practical and
cheaper.
The maintenance should also include a water conductivity test. A lot of
problems with autoclaves are caused by the usage of water of poor quality.
More under ↑Distilled water.
Then, we need of course cleaning material like: A bucket, dish washing
liquid, a sponge and a stainless steel scouring pad.
Maintenance procedure
A typical annual or better semi-annual maintenance procedure is the
following:
1. Drain the water from the reservoir. Clean the reservoir with a sponge
and distilled
water or with a soap solution if needed.
2. Remove the water filter (between reservoir and chamber). Rinse it
under running water
in reverse direction.
3. Remove also the water outlet filter which is found at the bottom of the
chamber. Rinse
this filter under running water.
4. The air inlet filter for ventilating the chamber after sterilisation has to
be replaced once
a year.
5. Do not forget to rinse all the cleaned parts with distilled water when
you are finished.
6. If the hospital uses rain water, make sure that the water is filtered
before it gets used
for the autoclave. In case of a doubt, talk
with the operator and find a solution. Maybe an additional filter (e.g. a
fuel filter from
a car accessory shop) can be added.
Limestone
Often the chamber and the heating element are covered with lime scale and
the tubes and valves are blocked with lime deposits.
The chamber can be cleaned by scraping of the scale with a scouring pad
which is used in the kitchen for cleaning pots and pans. Avoid steel wool, as
steel wool scratches the metal surface of the chamber.
Heating elements should be handled with care. They are made from soft
copper or brass pipes and are then coated or chrome-plated. They are less
durable than the thick stainless steel of the chamber. If you want to remove
lime scale from a heating element by scratching, you will destroy the surface
of heating element. The copper tube of the element is then visible and it will
not take much time until holes appear. That is very dangerous because the
intruding water creates an electrical connection to the power supply. The
whole autoclave is then under power then, which is particularly dangerous
when the electrical installation is poorly done and no earth-leakage circuit
breaker is installed in the mails supply.
The best way to remove limestone from a heating element is to remove the
heating element and put it in de-scaler which is used for water kettles and
coffee machines and leave it over night. Vinegar also works, but it takes
longer. You can also try denture cleaner.
Do not forget, better than removing limestone is to prevent it. Teach the operators in the
correct cleaning and ensure that they are using distilled water only.
Temperature calibration
For the calibration you need an external calibrated (digital) thermometer.
Only with such a reference meter are you allowed to calibrate the autoclave.
Never trust the internal thermometer.
The calibration of the equipment is only as good as your measurement
device. Do not use the cheapest and keep in mind that even the expensive
ones have to be calibrated after some time.
High quality multimeter with 2 mm sensor. This sensor fits e.g. into the test
port of Eschmann table top autoclaves.
Installation
The autoclave also has to stand perfectly horizontal. If not, the water
amount which is let in the chamber and detected by a level sensor can be
wrong.
Repair
Before starting a repair...
Error code
In case of a fault, microprocessor controlled autoclaves show an error code
in the display. With the help of the service manual the fault can be identified
easily.
The sensor has to be clean and free of debris. Check also the insulation and
the mounting of the sensor. But it is better to remove the sensor and clean
the individual parts.
The autoclave also has to stand perfectly horizontal. If not, the amount of
water which is let into the chamber and detected by the sensor can be
wrong.
Service manual
Service manuals are hard to come by. Some manufacturers are helpful and
send a copy on request, but most of the manufacturers do not.
If you need a manual you can also check here.
Spare parts
It is advisable to have a spare heating element in stock and if you have
more than one autoclave of the same type in your hospital, it is a must.
The same applies to door gasket. It is only a matter of time when a door
gasket will leak. Put one in stock.
Filters should also be kept in stock, especially bacterial filters which are
disposable and cannot be cleaned.
Gas steriliser
Some specific types of gas can also be used for sterilisation. Ethylene oxide
is such a gas which is used in special gas steriliser. It is a chemical agent
that kills micro-organisms, including spores.
Because a mixture of ethylene oxide in air is explosive and toxic, the gas
technology is complex and expensive and is only used where steam
sterilisation cannot be used.
The sterilisation process with gas depends on the gas concentration,
temperature and humidity but generally it takes much longer than the
sterilisation by steam. A typical sterilisation by ethylene oxide takes 16-28
hours at 50-60°C. After sterilisation, all materials have to be ventilated at
least 24 hours before contact with the skin.
Manufacturers
Important manufacturer of autoclaves are:
Autoclave
Autoclave tape
Sterilisation
Pressure
Pressure measurement