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Description: Sterilization.
Steam sterilizers.
Large sterilizers|Steam sterilizers, Sterilizers, Large, Sterilization
(hygiene), Medical equipment, Equipment safety, Safety measures,
Design, Marking, Dimensional tolerances, Signal devices, Control
systems, Temperature-measuring instruments, Pressure gauges,
Recording instruments (measurement), Performance, Safety devices,
Type testing, Performance testing, Leak tests, Air, Microbiological analysis,
Contaminants, Air permeability, Noise (environmental), Steam, Quality,
Pressure testing, Instructions for use,
Sterilization
Autoclaving is the most effective and most efficient means of sterilization. All
autoclaves must go through the GMP (good manufacturing practice) process of
autoclave validation / Qualification during which, the various programs are verified as
conforming to the requirements detailed in the User Requirement Specification (URS).
They operate on a time/temperature relationship. These two variables are extremely
important. Higher temperatures ensure more rapid killing. Some standard
temperature/pressures employed are 115ºC/10 psi, 121ºC/15 psi. and 132ºC/27 psi.
Longer times are needed for larger loads, large volumes of liquid, and more dense
materials. Autoclaving is ideal for sterilizing bio‐hazardous waste, surgical dressings,
glassware, many types of microbiologic media, liquids, and many other things. When
proper conditions and time are employed, no living organisms will survive a trip
through an autoclave.
Non-condensable gas test
The Non‐Condensable Gas Test demonstrates that the attainment of sterilisation
conditions in all parts of a steriliser load (particularly for porous load items) is not
impaired by the presence of non‐condensable gases.
The measurement of non‐condensable gases is made by cooling a steam sample with an
efficient condenser, using water siphoned from a tank at 200ml per minute. Minimum
requirements are: one metre head and water temperature below 28 degrees centigrade.
Pressurised water is not required. When the sampled steam is condensed any non‐
condensable gases present are released and separated from the cooled condensate into
sight glass columns.
Presence of air in steam
In a mixture of air and steam, the presence of air will cause the temperature to be lower
than expected. The total pressure of a mixture of gases is made up of the sum of the partial
pressures of the components in the mixture. This is known as Dalton's Law of Partial
Pressures. The partial pressure is the pressure exerted by each component if it occupied the
same volume as the mixture.
Example
Consider a steam/air mixture made up of ¾ steam and ¼ air by volume. The total pressure
is 4 bar. Therefore the steam only has an effective pressure of 3 bar as opposed to its
apparent pressure of 4 bar. The mixture would only have a temperature of 134°C rather
than the expected saturation temperature of 144°C. This could render autoclaving
ineffective where a minimum temperature is essential in order to kill bacteria. It is
therefore of paramount importance during the autoclave validation / Qualification task to
validate that all air has been removed from the chamber
Non condensable gas test – Manual method
1. Steam is sampling out of the steam elbow
2. Steam comes into the condenser coil
3. Since cold water coming at the outside of
the condenser coil, the steam will be
condensed and become condensate
4. Condensate is going into a container that is
full with cold water
5. Since condensate keeps coming into the
container, the overflow water is collected
in a measuring glass
6. Inside the measuring glass there is a
measuring burette that is HALF FULL with
water, we have to mark the water level
position at the beginning of the test
7. When the overflow water comes into the
measuring glass, air or other non
condensable gas will goes & move upward
into the burette
8. The water level inside the burette will drop
9. At the end of the test, we measure the
water inside the measuring glass and the
air volume inside the burette
10. Then we will find out the % of non
condensable gas inside the steam
Dryness test value
To ensure and to test that an acceptable amount of moisture is present in the steam
supply. For little amount of moisture there is a chance of superheating may occur. Even too
little moisture may prevent sterilizing conditions in the chamber. Steam with a dryness
fraction of 0.99 consists of 99% steam and 1% water. Similarly, steam with a dryness
fraction of 0.95 consists of 95% steam and 5% water. The dryness value of the steam
should be equal to or greater than 0.9 for porous loads or 0.95 where metal loads are
processed.
DRYNESS – Manual method
1. Prepare a thermos flask, check the
empty weight of the thermos flask
2. Fill the thermos flask with +/‐ 650 ml of
water & weight thermos flask
3. Check the initial water temperature
inside the thermos flask with the first
temperature sensor
4. Check the temperature of the steam
inside the steam test elbow with the
other temperature sensor
5. Insert a pitot tube at one of the port of
the steam test elbow
6. Connect a rubber hose from the pitot
tube to the thermos flask cover & open
the steam isolating valve
7. Steam will be coming into the thermos
flask
8. Stop the test & close the steam
isolating valve when the water
temperature inside the thermos flask is
about 80° C Shake the thermos flask
well
9. Check the new weight of the water
inside the thermos flask
Superheat steam test
There are quite a few reasons why superheated steam is not as suitable for use in steam
autoclaves. In heat transfer applications, steam with a large degree of superheat is of
little use because it:
a) Gives up little heat until it has cooled to saturation temperature.
b) Creates temperature gradients over the heat transfer surface as it cools to saturation
temperature.
c) Provides lower rates of heat transfer whilst the steam is superheated.
d) Requires larger heat transfer areas.
Superheat test – Manual method
1. Insert a pitot tube (orifice) into
one of the steam test elbow
port
2. Cover the pitot tube with a
special cover, so we can insert a
temperature sensor in it
3. Insert another temperature
sensor at the other port of the
steam test elbow
4. Open the steam isolating valve
5. Check the reading of the steam
temperature coming out from
the pitot tube to atmosphere
6. Check the reading of the actual
steam temperature inside the
steam test elbow
7. The superheat steam
temperature = The steam
temperature at the pitot tube ‐
The boiling water temperature
INTRODUCING:
Armstrong QM-3 steam quality testing equipment
QM-3
Steam QM-3/Automatic steam quality testing
Steam QM-3/Automatic steam quality testing
Steam QM-3/APPLICATION
Steam QM-3/INSTALLATION
Steam QM-3/Package
Steam QM-3/Communication
3rd party software for trending of QM3
3rd party software for trending of QM3