Medical Device Gamma Sterilization

In fact it has been a go to standard sterilization method for most medical devices over the past 40 years.

Medical device gamma sterilization. With a wealth of experience providing sterilization for medical devices steris ast has been providing a first. Gamma photons have the ability to penetrate deeply into material to provide a uniform sterilization dose throughout the volume of material. Firms may elect to comply with these standards. Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging.

Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes. The gamma irradiation process uses cobalt 60 radiation for a variety of applications including sterilization decontamination and materials modification. Sys 047 gamma sterilization validation procedure the purpose of this procedure is to define the requirements for gamma sterilization validation and revalidation using the vd max25 method which has been outsourced by your company to a contract sterilizer. The gamma sterilization process deploys gamma radiation in the form of cobalt 60 and an electron.

A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. To achieve your sterilization goals you may require ethylene oxide eo or eto gamma electron beam e beam x ray or nitrogen dioxide no2 technologies. Gamma sterilization technology is very well understood safe and easy to validate. It is an effective sterilization method due to its.

Steris applied sterilization technologies ast offers the medical device industry s most comprehensive array of contract sterilization options using gamma irradiation electron beam irradiation x ray irradiation and ethylene oxide sterilization. Medical device sterilization process. Sterility assurance treatment efficacy consistently meets product and regulatory requirements. Gamma irradiation is a simple and proven process for the safe reliable and effective sterilization of devices.

Gamma irradiation sterilization is performed by exposing the product to a radiation source typically cobalt 60 isotope which decomposes into nickel 60 isotope firing off gamma rays in the process. Safety offers proven track record in worker and product safety. However compliance to. To validate the sterilization dose an accurate measurement of radiation exposure is crucial.