Safety offers proven track record in worker and product safety.
Medical device gamma sterilization.
Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging.
Gamma sterilization technology is very well understood safe and easy to validate.
Gamma photons have the ability to penetrate deeply into material to provide a uniform sterilization dose throughout the volume of material.
Gamma irradiation is a simple and proven process for the safe reliable and effective sterilization of devices.
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.
With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.
The gamma irradiation process uses cobalt 60 radiation for a variety of applications including sterilization decontamination and materials modification.
To validate the sterilization dose an accurate measurement of radiation exposure is crucial.
However compliance to.
These gamma rays can penetrate through the entire product deactivating whatever microorganisms may be present.
Medical device sterilization process.
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.
Gamma irradiation offers good penetration of dense products and is ideal for many types of materials and their packaging.
It is an effective sterilization method due to its.
A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site.
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.
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.
The gamma sterilization process deploys gamma radiation in the form of cobalt 60 and an electron.
Sterility assurance treatment efficacy consistently meets product and regulatory requirements.
The pcl lab frequently sees medical devices that have been subjected to gamma irradiation sterilization.
