Category Archives: Product Validation

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 […]

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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.” […]

Also posted in Bioreduction, Chain Scissioning, Crosslinking & Polymer Modification, Molded Parts, Rheology Control, Sheet Processing, Sterilization, Wire, Cable, & Tubing | Comments closed

What is the cost to determine whether e-beam can sterilize my medical device?

  In order to determine if the necessary sterilization dose is delivered into a case of your product, we first need to perform a dose distribution (dose map) study. This study takes a measurement of the internal doses throughout a case of product. The case of product is opened by E-BEAM Services, and our trained […]

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What does it cost to validate product as “sterile” using e-beam processing?

There are many reasons why manufacturers of medical devices or pharmaceutical products often switch to e-beam sterilization, such as the high reliability of the technology, the quick turnaround time, the low cost and the ease of validation. (For more information about the advantages of using e-beam for sterilization, see my blog “Why do companies choose […]

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How do I know if my health care product is compatible with e-beam radiation?

Often, the first step in the qualification process is to determine the compatibility of your product with e-beam radiation. Some materials can experience a change in their properties with e-beam, so it is important to ensure the stability of your material and packaging at the beginning of the qualification process. Some initial guidance can be […]

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