Gas Sterilisation System with Ethylene Oxide (EO)
This tried-and-tested sterilisation method employed all over the world is nowadays highly standardized and, as a technically sophisticated method, represents a reliable option for sterilising materials without the risk of inflicting any damage. Unlike other techniques, EO sterilises efficiently even at low temperatures and is thus particularly suitable for use on plastics.
Medical devices are subject to a range of specific safety and compatibility requirements. Sterility is a fundamental requirement in ensuring that the devices are free from germs and can be employed without any concern.
As medical devices are frequently produced from a combination of different materials, sometimes feature very complex structures and often cannot be exposed to the high temperatures applied in steam sterilisation or the irradiation associated with radiation sterilisation, sterilisation with ethylene oxide (EO) is the method of choice when it comes to the sterilisation of medical devices.
During the process, the EO gas infiltrates both the packaging and the device itself, destroying any and all viable microorganisms. There are four parameters which are decisive for the success of the sterilisation process and these need to be coordinated precisely for each device:
- Gas concentration
- Temperature
- Relative humidity
- Exposure period
- Gentle and effective sterilisation of materials at low temperatures – This guarantees the integrity of the product and packaging
- Material compatibility – This procedure can be used to sterilise a wide range of materials and material combinations
Before a product can be assigned to a specific sterilisation process, the first step is to identify the parameters which guarantee the sterility of the particular product at the end of each cycle. This requires performance of a VALIDATION for the product.
Service steps in the preparation stage- Offer
(Based on your product’s specifications and packaging as well as the expected annual volume, we compile a customized offer for you including a specification of costs for both the validation and regular sterilisation) - Assignment
- VALIDATION
(= The verified development of a process which guarantees consistent success of the process (sterility) based on the same constants each time) - Changeover to routine sterilisation
- Incoming goods
The goods to be sterilised are delivered on EUR-pallets in their final packaging. - Pre-warehouse
The goods are then set up in the pre-warehouse. Each pallet is furnished with a coloured marker for visual identification and a bioindicator for subsequent microbiological examination. This is when the actual sterilisation process begins. - Preconditioning
This step comprises the humidification and preheating of the goods. (All the parameters which accompany the process are determined specifically for the cycle and subject to a prior validation.) - Sterilisation
Following repeated humidification in a vacuum, the goods are exposed to a precisely defined quantity of EO gas for a precisely established period of time. Once this exposure period has elapsed, the gas is extracted from the sterilisation chamber via a special degassing system and disposed of properly. The degassing of the goods continues in the subsequent desorption phases. - Postconditioning
The degassing of the goods is promoted in special postconditioning chambers by means of special temperature-control processes and a high rate of air renewal. - Laboratory
The documentation of the successful sterilisation is performed in the in-house laboratory with microbiological examination of the bioindicators. - Quarantine warehouse
The sterile goods are transported to the quarantine warehouse (high-bay warehouse), where they are stored until they are collected. - Outgoing goods
The sterile goods are collected and delivered to the customer.