E Beam Sterilization Validation

The sterilization validation requirements are set forth in the international standard iso 11137.

E beam sterilization validation.

Overview of an e beam irradiation validation for healthcare products prior to beginning routine processing with electron beam e beam irradiation a product with a sterile claim needs to complete a validation process to ensure the sterility assurance level claimed is achieved. Confirm that the sterilization process was validated by reviewing the validation study. A the sterilization dose needed to support a claim of sterility sal and b the maximum acceptable dose identified in high dose testing as noted above. E beam services will help guide you through the ansi aami iso 11137 validation requirements for the sterilization of medical devices using radiation and usp guidelines for the sterilization of pharmaceuticals.

He now brings this knowledge to steri tek in order to help guide customers through the validation of terminal sterilization for medical devices. Check back in for my future blog how do i validate my medical device for e beam sterilization for details on what each step entails. During his previous employment he learned the ins and outs of medical device sterilization via e beam x ray irradiation. Steri tek provides turnkey sterilization validation packages per iso 11137 vdmax for companies that wish to outsource their sterilization validation work.

To claim your product is sterile after e beam treatment you must perform several validation steps as regulated by iso 11137. E beam sterilization is very gentle on product material and packaging when compared to gamma sterilization and is compatible with most materials. Although e beam product penetration is highly dependent on electron energy and has reduced penetration for dense products. Materials testing and establishing maximum dose.

Review the specific procedure s for the sterilization process selected and the methods for controlling and. It may include technical consultation services protocol development management of the irradiation and microbiological testing plus final reporting. The sterilization validation process. This validation process is comparable to that of gamma sterilization and it is simpler than the process for eto sterilization.