ENGLISH
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13.1 Chemical integrators
These tests (spare code 200/S and 215-S) are based on the properties of indicator dyes
that are able to modify their own aspect if they are adequately exposed to heat and
pressure according to given times, since they interact with all the cycle parameters
(pressure, temperature, time). If the test is successfully completed, the correct stability is
validated.
USE
RESPONSE
PERIODICITY
13.2 Biological indicators
The test (spare code 262-S) is used to prove the autoclave capability as to the complete
destruction of all microorganisms. It is represented by a standardized spore preparation,
having biological characteristics, high resistance to heat, which is to be deemed an
absolutely safe control tool (ATCC 7953).
It consists of spore ampoules. It is non pathogenic, non toxic and non pyrogenic.
USE
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AUTOCLAVE VALIDATION TESTS
The chemical integrators (spare code 200/S o 215-S) are to be put into the
sterilization chamber before starting the cycle, even with the load already
in. The integrators can either be unwrapped and positioned into the trays
or they can be wrapped into the sterilization bags together with the
materials to be sterilised. In any case it is advisable to wrap the integrators
where there are many operators. As a matter of fact by doing so the
sterilization of every single tool will be certified.
There is no preset testing interval, apart from areas to which specific
regional regulations apply. In any case all the chemical integrators are the
cheapest and quickest available tests, hence in order to constantly monitor
the autoclave performance, it is advisable to use them on all of the
cycles or at least once a day.
The ampoules shall have to be put into the sterilization chamber even
when loaded.
Carry out the cycle and then take out the ampoule by taking care since it is
hot and pressurized.
Leave it cool down for about 10 minutes and then activate it by using the
supplied crusher by taking care so as to keep the ampoule always upright.
The chemical indicator placed on the label of the ampoule will have
changed its colour from blue into black. Subsequently incubate the
ampoule into a biological incubator at 57° C for 48 hours, together with an
unprocessed test ampoule, that has anyway be activated through the
relevant crusher.
If the colour change remains
within the white area, the test
failed
If the colour change enters the
SAFE window, the test
succeded