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 changes in the manufacturing process or materials used.

 

For example, your initial bioburden testing might establish that you need a minimum dose of 15 kGy to sterilize your medical device. But, Chuck, the guy responsible for changing the air filters in your manufacturing facility, won the lottery and took off on an extended trip to the Maldives (lucky Chuck).

While Chuck’s been gone, no one remembered to change the air filters, and you’ve been slowly pumping dirtier and dirtier air back into your facility, adding to your bioburden. Suddenly, that 15 kGy isn’t enough to sterilize your medical device. But you don’t figure this out until 8 months later and have to recall thousands of potentially contaminated medical devices, face dozens of lawsuits and the overwhelming guilt of having provided contaminated medical devices to patients in need.

Sounds painful, huh?

But you’re smart. You follow the ISO 11137 standard and have E-BEAM and your microlab perform a dose audit on your product every quarter. E-BEAM irradiated the samples at the specified verification dose (sublethal dose) and sent the samples to your lab, who tested the product for positives. When there were more positives than allowed, the red flag went up and you were able to go back and pinpoint the air filter dilemma and rectify it faster than Chuck can down a piña colada.

Still not sure how a dose audit works with your product? Reach out to us at ebeam@ebeamservices.com and we’ll help you out!

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Showcasing Green Sterilization Solutions to Assist Speed to Market of Medical Devices at MD&M West

MD&M West

As the medical device market faces unprecedented growth projections and demands, the E-BEAM Services experts join engineers and executives from around the globe at the MD&M West in February to explore innovations and partnerships. Considering the pace of the MedTech sector into this next decade, the MD&M show proves to be the place to understand advancements and the increasing demand for sterilization solutions like e-beam.
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A few notes of thanks…

 

As the year winds down and we look back at all that has happened in 2019, we find ourselves overwhelmed with gratitude! Here are a few things some of the E-BEAM folk are thankful for in particular.

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What is the difference between Bioreduction and Sterilization?

 

One of the questions we get often is: What is the difference between bioreduction and sterilization?

Check out the latest Crash Course above to find out!
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The Power of Electrons is in Minneapolis with E-BEAM Services 

 

MD&M Minneapolis 2019: E-Beam Services is getting ready for a trip to the Twin Cities next week!

The team will be talking about the wonderful world of electrons for clean, quick, consistent sterilization with attendees at the Medical Design and Manufacturing (MD&M) Minneapolis. Minneapolis is a hotspot for the newest advancements in medtech and this show never disappoints us with opportunity. 
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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 be penetrated by e-beam. End of the e-beam road, right?
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MD&M East: The Big Apple Welcomes Electron Experts E-BEAM Services

MD&M East

It’s June, and that means E-BEAM Services will be in NYC next week, taking in a show, eating a hot dog or two in Central Park, and bringing the science of electron beam sterilization to the MD&M East trade show.

This show is always the place to be in the medical device world as the largest and longest-running medtech event on the East Coast. We love it not just because NYC is a great place, but because we also get to learn the latest in industry advancements, including first looks at innovations yet to hit the market and to explore new applications for e-beam sterilization. 
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How do I convert from ETO or Gamma to E-beam sterilization?

conversion 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 a daunting task.

The good news? We’re here to walk you through it!

If you’re interested in converting and want to know more about how we can help you specifically, email us at ebeam@ebeamservices.com to set up a free consultation call.

In the meantime, here is a quick rundown of the steps needed to convert from ETO or Gamma.
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Crash Course Recap: The Polymer Dating Game

 

Whether you need terminal sterilization or crosslinking, your product either consists of or is packaged in at least one polymer. How those polymers react to e-beam is extremely important. In the E-BEAM Crash Course: The Polymer Dating Game, we take a look at three common polymers, and how they react to e-beam.
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Posted in Chain Scissioning, Crosslinking & Polymer Modification, E-Beam, Property Improvements, Sterilization | Comments closed

E-BEAM Services to Showcase Power of Electron Enhancement at NA FOAM EXPO

E-BEAM Crosslinked Foam

E-BEAM Services is sending their product enhancement expertise on the road this March for North America’s leading exhibition for the technical foam manufacturing supply chain: the Foam Expo North America Conference.   

We are proud to add value to the world of foam with our highspeed innovative process (and thank the organizers of Foam Expo for the opportunity to showcase the technology). Electron beam processing is used to create crosslinked foam.    
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Posted in Crosslinking & Polymer Modification, E-Beam, Sheet Processing | Comments closed