IBS MediaClave, Руководство пользователя

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MediaClave overview
INTEGRA Biosciences
Page 26
4.3 Program operation
4.3.1 MEDIACLAVE program operation
4.3.1.1 Overview
The flow of the MEDIACLAVE sterilisation cycle is as follows:
System check
→
Pressure test (excluding MEDIACLAVE program 14)
→
Heating
→
Sterilisation
→
Cooling
→
(MEDIACLAVE program 15 only: Heating)
→
Boiling
→
Cooling
→
Dispensing
→
End of
cycle
4.3.1.2 System check
All instrument functions and corresponding sensors are initialised and checked during a system check.
4.3.1.3 Pressure test
During a pressure test, the vent valve closes and the compressor operates for a maximum of 90 seconds.
When the target pressure of 0.1 bar is reached, the compressor stops and the vent valve re-opens.
4.3.1.4 Heating
The heating phase brings the product temperature to the programmed target value. To ensure the sterili-
sation of the heat space inside the vessel, the vent valve remains open until the air vent parameter has
been reached. This allows water vapour to escape from the system, thus all non sterile air is removed. If
the target value is below 100°C, the vent valve closes at target value minus 3°C.
4.3.1.5 Sterilisation
The product is maintained at the programmed target value for the specified duration of the sterilisation
phase. The maximum sterilisation temperature is 122°C and the corresponding maximum pressure is ap-
proximately 1.2 bar.
The sterilisation time runs if the temperature is within the defined tolerance
band .
4.3.1.6 Cooling
The cooling phase reduces the temperature and pressure to the programmed target values. External cool-
ing water is flowing through the heat exchanger. The coupling medium is pumped through the inner ring
of the heat exchanger and is cooled down to the required target value. There is only a thermal connection
between coupling medium and tap water, therefore no contamination is possible. In order to prevent gel
formation, a minimum cooling temperature can be defined as an option.
ATTENTION:
If the pressure test fails, remove the rubber lid seal, wet it well and insert it again.