First the products to be sterilized are inserted into the sterilization chamber. Then the chamber
is held under vacuum and hydrogen peroxide vapor is injected into this vacuum at a concentration of
up to 60%.
The hydrogen peroxide has a sterilizing effect on all accessible surfaces. Then the chamber is put under vacuum again, to remove the lager part of the H2O2.
For cleaning purposes the remaining gas is made to pass over into the plasma state through high frequency voltage. In this plasma various species of H2O2 are produced that are finally recombined as water (H2O) and oxygen (O2).
To present evidence of the sterilization with the desired degree of certainty, it is shown that at least
106 colony forming units that are particularly resistant to the procedure can be killed during the cycle
The process is performed twice to achieve the required sterilization (half-cycle procedure).
Our tests are supported by an accredited laboratory. Routine inspections and the annual revalidation of the processes are performed by us. This enables us to have a prompt process approval.
As in the case of other sterilization procedures, the bioburden should be known and should be relatively stable. The inspection for a continued high performance, i.e. material inspection should be performed after artificial and actual storage. Biocompatibility tests are run immediately after the dual sterilization as needed.
We will be happy to recommend to you an accredited lab for such tests as required.
To guarantee a good penetration of the packaging material H2O2, cellulose-free packaging should be chosen. Paper and cardboard can not be used for this sterilization procedure because of their interaction with H2O2.
We will be happy to provide you with a quote for your packaging problem.
Gas plasma sterilization has several advantages as compared to other sterilization methods.
For example, the temperature is adapted to the product. We can perform tailored sterilization in a range of 37° to 60°C. Our standard cycle is run at 50°C. This means that there is practically no thermal load of the sterilized products.
Excellent results are achieved with the sterilization of membranes. It is well known that retention properties are partly lost when they are sterilized with radiation. After a gas plasma sterilization their properties remain unchanged. Similar positive experiences have been made with sensitiveelectronic components.
Gas plasma sterilization has been long used on a routine basis because of the low power loss.
The standard procedure is quite sufficient for a lot of products. If it should not be gentle enough for your product the process is adapted to the product configuration.
Gas plasma sterilization procedures usually take between one and two hours, including preparation and finishing.