Steam
sterilisation is
conducted inside of a pressure device – steam autoclave equipped
with a thermostat, a manometer, and suitable safety valves.
The
sterilising agent during steam sterilisation process is saturated
steam under pressure in temperature 121°C (steam
pressure around 2 bar) or
in temperature 134°C
(steam pressure around 3 bar). In order to achieve the full effect
of steam sterilisation the sterilised material needs to be exposed to
saturated steam under pressure for a certain time. All the surfaces
of sterilised materials need to be in contact with the steam,
therefore the sterilisation time depends on the size of the load and
the type and density of sterilised material and takes between 20-30
minutes.
According
to the European norm the sterilisation
process
needs to provide sterility
assurance level
SAL=10"6. This indicates that the risk of obtaining a
non-sterile product is 1: 1000000.
The
sterilisation process is a technological process composed of several
tasks which lead to obtaining a sterile product. The process is
performed so that each sterilisation results in a product of
identical quality. Therefore the sterilisation process should be
validated and routinely monitored and the autoclaves should be
maintained in full operation.
Steam
sterilisation is a universal, sure, fast, non-toxic and economic
method.
Steam sterilisation process
is composed of the following stages :
- The rise time – the interior of the autoclave is vented i.e. the air is removed and entirely replaced by saturated steam.
- The compensation time - after this period, the article to be sterilised has reached the required temperature at every point.
- The sterilisation phase - the duration is dependent on the sterilisation temperature and the microorganisms to be destroyed.
- The cool-down phase – the time needed for the pressure inside of autoclave to fall until it is the same as the atmospheric pressure.