Medical

The sterilization of medical products using Electron Beam processing is one of the most effective methods available to the disposable medical product manufacturing industry. An environmentally friendly process, it is exceptionally convenient and offers fast turn-around times.

Electron Beam processing has the ability to kill bacteria, thereby rendering a product sterile. Sterilization with electrons has significant advantages over other methods of sterilization currently in use. The process is:

• Quick,
• Reliable
• Compatible with most materials
• Does not require any quarantine following the processing.

Medical products can be exposed to the beam after final packaging because the electrons have the ability to penetrate through the packaging to sterilize them. This allows the package to remain intact and guarantees that the product will remain sterile until required for use.

Currently, most disposable medical products are sterilized with EtO gas, or Gamma rays. Various difficulties with these methods have led to increased interest in Electron Beam sterilization. Much of the interest has been fueled by the environmental friendliness of Electron Beam processing when compared to these other methods. Unlike the alternatives, Electron Beam processing does not make use of any hazardous or radioactive materials.

Quality Assurance: 

Medical device manufacturers and packagers face stiff regulations for product sterilization. The validation process can be laborious, time consuming and expensive. Iotron provides assistance that will minimize these factors and help bring your product to market in the shortest possible time.

• ISO 9001 and ISO 13485 registered quality system
• Dose selection assistance – i.e. Method VDmax
• Material compatibility testing
• Validation in accordance with ISO 11137 - new products or new sterilization method

For more information about Electron Beam processing of your medical products, please contact us.