These gamma rays can penetrate through the entire product deactivating whatever microorganisms may be present.
Medical device gamma sterilization.
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.
With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.
The pcl lab frequently sees medical devices that have been subjected to gamma irradiation sterilization.
Gamma irradiation offers good penetration of dense products and is ideal for many types of materials and their packaging.
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.
The gamma irradiation process uses cobalt 60 radiation for a variety of applications including sterilization decontamination and materials modification.
Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging.
To validate the sterilization dose an accurate measurement of radiation exposure is crucial.
Gamma sterilization technology is very well understood safe and easy to validate.
Sterility assurance treatment efficacy consistently meets product and regulatory requirements.
The gamma sterilization process deploys gamma radiation in the form of cobalt 60 and an electron.
Gamma irradiation is a simple and proven process for the safe reliable and effective sterilization of devices.
A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site.
Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes.
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.
Medical device sterilization process.
However compliance to.
It is an effective sterilization method due to its.
Safety offers proven track record in worker and product safety.
Firms may elect to comply with these standards.
