Category Archives: Product Validation

Crash Course Recap: The 4 Steps to Sterilization Validation

E-BEAM’s latest Crash Course walks the viewer through a quick overview of the four main steps to sterilization validation. To be able to officially declare your medical device as sterile after processing, you must first perform a sterilization validation. Radiation sterilization methods, like e-beam, are monitored by the ISO 11137 standard. But don’t worry, both […]

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What is a dose map and how much does it cost?

A dose map, or dose distribution study, helps us determine if all of the product within your case is receiving the necessary sterilization dose. In this study, we take a measurement of the internal doses throughout a case of product. The case of product is opened by E-BEAM Services, and our trained lab technicians place dosimeters at […]

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Dear Karen: How many samples do I need for an e-beam material test?

  Dear Karen, I am a new startup company, and am trying to get my product validated for e-beam sterilization. How many samples do I need to send you for the material test? And, while we’re talking about material tests….what are they? Sincerely, Material Girl

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The Story of E-BEAM Services: Sterilization

We are E-BEAM Services, we are committed to the power of electrons, and we are electron sterilization. In the video below, you will discover how E-BEAM Services has revolutionized the sterilization market with the power of electrons.     Transcript The story of E-BEAM Services is the story of commitment. Commitment to the power of […]

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Is my product compatible with e-beam sterilization? At what maximum dose? What’s it cost to determine that?

  Medical device manufacturers want to know if their product is compatible with e-beam sterilization; they can do it by performing a simple experiment.  This experiment includes exposing a number of samples to a range of doses to see the effects of the radiation on their product materials and the packaging.  Not only will the […]

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What is a dosemap and what does it tell me?

In electron beam processing, a dosemap measures the distribution of dose, typically within a case of medical devices to be sterilized. (The principles also apply to other types of electron beam processing.) We are usually looking to determine the maximum internal dose and the minimum internal dose.

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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.” […]

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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 lab […]

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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 […]

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