How is a sterilization dose measured in the e-beam irradiation process?
Are you ready for the shocking truth? Truth is, we can’t actually guarantee sterility of any products we “sterilize.” Don’t panic just yet though! We are fully capable of certifying the dose the product received—the dose that you and your microbiological lab determined was needed to qualify your product as sterile.
How do I validate my medical device for e-beam sterilization?
To claim your product is sterile after e-beam treatment, you must perform several validation steps, as regulated by ISO 11137. This validation process is comparable to that of gamma sterilization and it is simpler than the process for ETO sterilization. If you do not have a microbiology lab in-house, you will need to partner with […]
What can I expect from E-BEAM as a company?
Let me tell you a story. In June of 2013, I was standing in our booth at the MD&M show in Philadelphia when I turned to face a stately looking gentleman holding some sort of medical device in his hand. He was shaking his head, saying “you sterilization guys have a history of horrible service.” […]