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D33340 | Date 08/2017
Sterilisers SFplus/SNplus
8.
Notes on sterilisation
8.1 Contraindications / unwanted side effects
Since hot air sterilisers don’t have a direct therapeutic intended use, the aspects of contraindi-
cation and unwanted side effects are not relevant.
8.2 Note in accordance with Medical Devices Directive
The product lifetime as intended by the manufacturer is eight years.
8.3 Guidelines for sterilisation
For hot air sterilisation, there are different guidelines on the temperature and sterilisation time
to choose, as well as on packaging the sterilisation load. The values to be chosen depend on
the type and characteristics of the load to be sterilised and on the type of germs to be neutral-
ised. Before beginning sterilisation, make yourself familiar with the sterilisation method laid
down for your application.
Process parameters for hot air sterilisers are temperature and minimum hold time. The follow-
ing process parameters have been defined in recognised standards:
►
According to WHO: 180 °C with a minimum hold time of 30 min
►
According to the European Pharmacopoeia: 160 °C with a minimum hold time of 120 min
For the inactivation of endotoxin (pyrogenes), dry heat of at least 180 °C can be applied. For
the depletion of pyrogenic substances, you have to keep a combination of temperature and
time going beyond the requirements of sterilisation.
Inactivation of endotoxin is possible using the following process parameters (data in accord-
ance with EN ISO 20857:2013):
►
180 °C with a minimum effective time of 180 min
►
250 °C with a minimum effective time of 30 min
Caution:
The temperature and time requirements normal for hot air sterilisation do not destroy
endotoxins.
Especially when the appliance is heavily loaded, using these parameters without checking
them will not be sufficient. For safe sterilisation, validation of the individual sterilisation pro-
cess is required. The requirements for the validation of sterilisation by dry heat are e.g. defined
in standard EN ISO 20857:2013. Also valuable is the "guideline on validation and routine
monitoring of sterilisation processes using dry heat for medical products" issued by the Ger-
man Society for Hospital Hygiene (DGKH).
