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.

To validate the sterilization dose an accurate measurement of radiation exposure is crucial. 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. Firms may elect to comply with these standards. With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.

Sterility assurance treatment efficacy consistently meets product and regulatory requirements. 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. It is an effective sterilization method due to its. However compliance to.

These gamma rays can penetrate through the entire product deactivating whatever microorganisms may be present. The pcl lab frequently sees medical devices that have been subjected to gamma irradiation sterilization. Gamma photons have the ability to penetrate deeply into material to provide a uniform sterilization dose throughout the volume of material. Gamma irradiation offers good penetration of dense products and is ideal for many types of materials and their packaging.

Gamma irradiation is a simple and proven process for the safe reliable and effective sterilization of devices. 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. The gamma sterilization process deploys gamma radiation in the form of cobalt 60 and an electron. Safety offers proven track record in worker and product safety.

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. Medical device sterilization process. The gamma irradiation process uses cobalt 60 radiation for a variety of applications including sterilization decontamination and materials modification. Gamma sterilization technology is very well understood safe and easy to validate.