Now certified! The certification of the quality management system according to DIN EN ISO 13485 has now been followed by the certification of the contract sterilisation service according to DIN EN ISO 14937.
Gas-plasma sterilisation by means of hydrogen peroxide is an innovative sterilisation procedure, which is in the process of establishing itself from use in the clinical area all the way to the industrial production of medical products.
This service is available with immediate effect from Heinz Meise GmbH Medizintechnik.
Example of a standard process:
At first the chamber is filled with the items.
Then it becomes evacuated, and a quantity of 59% H2O2 is injected into the vacuum.
While the injection time the H2O2 has its sterilising effect.
In the next step the chamber becomes evacuated again.
With the residual gas a physical plasma is started with high – frequency voltage. During the plasma phase the H2O2 gets destroyed into different species and finally reacts to water and oxygene.
The procedure runs two times.
The process of gas-plasma sterilisation has a number of advantages compared to other sterilisation procedures. For example, the temperature is adapted to the product. For a great many products a standard process with 45°C to 50°C is completely adequate. Should this not be mild enough for a product, a procedure can be developed which is fine-tuned to the particular product. Meise GmbH is able to sterilise in a range from 37°C to 60°C. Thanks to this adaptation, no thermal loading of the sterile goods occurs.
As a result of these possibilities very good results were achieved with the sterilisation of plastics, but also of fine structures such as membranes, where for example after sterilisation a portion of the retentive properties is lost after radiation, while the properties remain unchanged after gas-plasma sterilisation. The case is similar when it comes to sensitive electronic components and for accumulators – as a result of the slight performance losses, gas-plasma sterilisation has long since become routine.
To substantiate the sterilisation with the certainty required, it is shown that at least 1*106 bioindicators with a particular resistance to the procedure can be killed off in the cycle. The bioindicators are introduced at the point least suitable for sterilisation in the medical products.
To substantiate the required sterilisation performance, the process is repeated twice (validation according to the half-cycle procedure). As in other sterilisation procedures, the bio-burden should be known and relatively stable and the test of the preservation of the effectiveness, i.e. the material tests also be carried out after artificial and actual storage. If required, the biocompatibility tests are carried out directly after double sterilisation.
Good to know
For good permeation of the packaging material with H2O2 Tyvek welded with PE sheeting can be used. Due to the interaction with H2O2, paper with cardboard is out of the question.
The normal process times in the case of gas-plasma sterilisation including pre- and post-treatment amount to between one and four hours