Contract Sterilization

Eagle Medical provides contract sterilization services using ethylene oxide (EtO), gamma irradiation, and vaporized hydrogen peroxide (VHP). Eagle Medical can provide a wealth of information useful in determining which sterilization method is best for your product.

The diversity of sterile medical products on the market is staggering. New, innovative developments are continually being introduced. Determining the best method for sterilization is not as easy as it once was. Material compatibility, temperature concerns, radiation stability, off gassing, design configurations, and quick turn around are all concerns that manufacturers must address when considering sterilization options. Fortunately, there are a variety of sterilization methods available to meet your needs.

Steam, irradiation, and ethylene oxide (EtO) are by far the most common sterilization methods utilized in the industry, but limitations exist with each. Steam exposes devices to high heat and humidity. Irradiation can change the molecular make up of plastics and silicones in an undesirable manner. Ethylene oxide requires off-gassing that is time consuming with some materials.

Gas Plasma (Vaporized Hydrogen Peroxide)

Eagle Medical, Inc. is pleased to offer contract sterilization using Vaporized Hydrogen Peroxide (VHP).

Gas Plasma (vaporized hydrogen peroxide) is a relatively new option that can provide low heat sterility cycles with none of the off-gassing concerns present with EtO. Gas Plasma (VHP) sterilization has, until now, been exclusively used by large manufacturers as the end line process for in-house sterilization.

If you are currently using EtO but need quicker turn around, you should consider using VHP.

Eagle Medical provides a documented sterility validation for submission with 510(k), or Pre-Market Approval (PMA).