EO Sterilizers Demands in Europe

EO Sterilizers are a low-temperature gaseous process, which means they are safe for plants and soil organisms. Unlike chemical fertilizers and pesticides, EO Sterilizers are effective at room temperature. Here are a few benefits of EO Sterilizers. They prevent the spread of infectious diseases. These methods are also beneficial for a number of industries.

EO Sterilizers Follow a Low Temperature Gaseous Process

EO sterilization is one of the most popular methods of sterilization, with over 20 billion medical devices sterilised every year. This low temperature gaseous process is used in over half of medical supplies used in the U.S., and is a vital part of the healthcare supply chain. Alternative sterilization methods may not provide the same level of sterility assurance. They may also cause material degradation. EO sterilization does not endanger public health.

EO Sterilizers are not Exposed to Excessive Heat

EO sterilizers are typically used in hospitals, as their use is widely accepted. The EO sterilization process is a complicated operation, and the use of the EO is widely accepted in Germany, France, and Switzerland. Europe. As a result, the use of an Ethylene Oxide sterilizer is widely accepted.

Unlike gamma-ray sterilization, EO does not expose products to high levels of heat or radiation. EO is effective for a variety of materials, including polymeric components commonly used in medical devices. AAMI TIR-17 describes the material compatibility of EO and the processes required to produce it. EO can be sterilized in the final packaging for products that have to be shipped. Because EO permeates sealed packaging, EO sterilization is highly effective.

Industrial ETO Sterilizer

EO Sterilizers are not Harmful to Soil Organisms

EO is safe for soil and aquatic life. The chemical is not harmful to human health. To ensure the safety of EO Sterilizers, manufacturers must meet stringent safety standards. They should meet European Union requirements for environmental protection and human health. Ethanol (Ethanol) is a bactericidal and fungicidal, and it has antimicrobial activity against both plants and soil organisms. But alcohol is not suitable for sterilization due to its flammability and rapid penetration of various materials.

EO Sterilizers must Comply with International Standards

EO sterilizers must be certified by European and international organizations to meet the high safety and quality standards in medical devices. EO sterilizers are certified by the European Union, the European Medical Association, and the Food and Drug Administration. ISO 10993-7 is a recognized standard for residual testing of medical devices. Despite the similarities between the two standards, the European Union has stricter requirements for EO sterilization.

In order to obtain an EO certificate in Europe, manufacturers must demonstrate that their devices are free of contamination. The documentation of sterilization process parameters must be backed up with valid data obtained through experiments and data analyses. Moreover, sterilization process parameters must be monitored for each batch. Among other things, this data must include pressure, temperature, gas flow rate, operator name, and environmental conditions such as humidity.

The Bottom Line

EO Sterilizers are the most effective sterilization methods for long-loop instruments and materials. Generally, EO sterilization is performed at a temperature of 25-55 degrees Celsius. Lower temperatures, however, result in an efficient process and less exposure times. However, this low temperature approach is still useful for a variety of applications. EO Sterilizers are highly effective for sterilizing medical devices.