Medical device sterilization process.
Medical device gamma sterilization.
Safety offers proven track record in worker and product safety.
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.
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.
Gamma irradiation offers good penetration of dense products and is ideal for many types of materials and their packaging.
Gamma photons have the ability to penetrate deeply into material to provide a uniform sterilization dose throughout the volume of material.
To validate the sterilization dose an accurate measurement of radiation exposure is crucial.
The pcl lab frequently sees medical devices that have been subjected to gamma irradiation sterilization.
In fact it has been a go to standard sterilization method for most medical devices over the past 40 years.
Gamma sterilization technology is very well understood safe and easy to validate.
With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.
Gamma irradiation is a simple and proven process for the safe reliable and effective sterilization of devices.
The gamma sterilization process deploys gamma radiation in the form of cobalt 60 and an electron.
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.
Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes.
These gamma rays can penetrate through the entire product deactivating whatever microorganisms may be present.
Firms may elect to comply with these standards.
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.
Sterility assurance treatment efficacy consistently meets product and regulatory requirements.
