EB Benefits

Medical devices that are a combination product are typically sterilized using ethylene gas. This is because of FDA requirements states that drug components of the combination product cannot be sterilized with radiation. There is a proven alternative: Controlled Depth Sterilization utilizing an electron Beam (EB). This sterilization method can be done on-site with an in-line packaging option.

Some Advantages of EB Radiation:

• Established and proven sterilization technology
• Sterilization can be completed in-line within a facility
• Minimizes product inventory and shipping costs
• Routine production can use standard dosimetry data for product release
• Concerns about gas residuals are eliminated
• The product is sterilized quickly and can be shipped immediately

The in-line EB process is designed and controlled to assure the EB penetrates the packaging, but does not enter through the contents. No radiation penetrates though the drug container or comes in contact with the drug. This process is simulated and detailed with verified 3D software.