In the world of medical device and pharmaceutical manufacturing, timely and accurate sterilization validation is crucial. However, the validation process often poses challenges, causing delays in getting products to market. That’s where E-BEAM Services’ STAT Sterilization Validation services come into play! Designed to expedite the validation process, these services offer medical device and pharmaceutical manufacturers […]
Category Archives: Product Validation
Introducing STAT Sterilization Validation Services
Also posted in E-Beam, Sterilization
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What special packaging materials do I need for e-beam sterilization?
One question we get often is, “What special packaging materials do I need for e-beam sterilization?” The short answer: None!
Also posted in Processing Capabilities, Sterilization
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Why do you perform a dose audit?
Most of our sterilization customers have us and their microlab perform a dose audit (also known as a sublethal or dose verification) on their products on a quarterly basis. The purpose of this test, simplified, is to audit the minimum dose needed to achieve sterility and make sure it hasn’t increased due to any potential […]
Also posted in E-Beam, Sterilization
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Crash Course Recap: What do I do if my packaging is too dense?
E-beam sterilization can be a good fit for a lot of different products, thanks to its fast dose rate and the fact that it doesn’t need a radioactive or carcinogenic source like some other sterilization options. But deciding to use e-beam is only the first step. Sometimes, existing packaging configurations are too dense to […]
Also posted in Bioreduction, E-Beam, Processing Capabilities, Sterilization
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How do I convert from ETO or Gamma to E-beam sterilization?
Whether you’re looking for faster processing time or something more environmentally friendly, e-beam can be a great choice for terminal sterilization. However, the thought of going through the conversion process from an existing sterilization method can have those of you in quality hiding under your desks. The bad news? Yeah. Not gonna lie. It’s […]
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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, […]
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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 E-BEAM: How many samples do I need for an e-beam material test?
Dear E-BEAM, 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 […]
Also posted in Bioreduction, E-Beam, Processing Capabilities, Sterilization
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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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