Ethylene oxide sterilization (EO or ETO) is one of the most common methods for sterilizing medical devices and instruments. With this method, the products are exposed to ethylene oxide in a sealed vacuum chamber. ETO sterilization is a chemical process with four main variables: gas concentration, humidity, temperature, and time.
Since ethylene oxide can penetrate numerous layers of gas-permeable packaging, it is ideally suited for sterilizing a variety of materials that are not compatible with other sterilization methods (steam, radiation, etc.). It is gentle on the materials of the medical device. The know-how is based on over 4 decades of practical experience. Our validated in-house sterilizing plant completes our comprehensive range of services for our customers. Product sterility is assured and documented using established test procedures.
Pre-conditioning/acclimatization:
Acclimatization of the goods through storage at room temperature
Automated sterilization process:
Vacuum test
Conditioning
Controlled gassing with ethylene oxide gas mixture
Sterility test and release:
Bioburden test: The aim of bioburden testing is to determine the exact number of viable microorganisms (fungi and bacteria) on the surface of medical devices, for example. It is used for quality control of medical devices and components used in the medical field.
LAL test: The “Limulus amoebocyte lysate” test is considered the gold standard for testing for pyrogens.
Release certificate
In October 2023, the start was given for the expansion of sterilization capacities in order to meet the increasing demand. Further information can be found here.
The department covers about 100m². Currently the department has around 10 employees.