Frequently Asked Questions
What do you have questions about?
E-BEAM Services’ Quality Management System is certified to ISO 13485:2016 and our sterilization services fulfill applicable quality management system requirements within EN ISO 11137-1:2015. In addition to that, we adhere to cGMP requirements and our FDA-registered facilities are subject to routine inspections.
Of course! We love to meet our customers in person. Contact us to arrange a visit.
Yes. We can provide an hourly rate for specialty processing. Reach out to your Tech Services representative for a quote.
Yes, we can ship worldwide!
After product qualification is complete, a credit application will be sent by your Tech Service representative. Once credit is granted, you will be approved for Net 30 terms.
Of course!
Yes, we are FDA registered and compliant and audited in both facilities on a routine basis.
Yes. It is based on the time of your request and your specific processing needs.
With credit approval, our terms are Net 30.
Yes. Please call 513-933-0031 to schedule an appointment at our Ohio facility, or call 609-655-7460 to schedule an appointment at our New Jersey facility.
No, we do not sell the equipment. We provide sterilization and polymer modification services.
The office is open Monday through Friday, 8:00-5:00 pm.
Typical turnaround time is 1-2 weeks. We ask for advanced notice for scheduling. We also offer expedited services, including same day processing.
We have two locations qualified for sterilization and crosslinking, one in Lebanon, Ohio and one in Cranbury, New Jersey.
Yes, our Ohio facility has been licensed to sterilize Class III non-narcotic controlled substances since May 2016.
E-BEAM Services is dedicated to providing uninterrupted priority sterilization services for products used for COVID-19 response, including test tubes and swabs used in kits to test for coronavirus. For more information, click here.
No, we perform the dose exposure portion of the test (for dose verification and dose audits) and we will be happy to work with your lab of choice, or we can provide you with contact info for labs that can perform the testing.
Yes, we offer decontamination and sterilization for food products, except for fresh produce.
Nope. Products are ready to leave our facility as soon as they are processed, no radiation included. (Sorry, you’ll have to get your superpowers some other way.)
We will process your product at two or three different dose levels, depending on your specific product and end goal. We will then send the samples back to you (or your lab) for testing.
Minimum dose is usually determined through bioburden testing with your lab of preference in accordance with the applicable regulatory standards, such as ISO 11137 for medical devices.
The dose will be determined based on the property improvement desired (e.g. material modification or sterilization), material compatibility testing, and dose distribution studies.
Contact us to learn more about potential incompatibilities, but usually it involves a trial where we will expose samples at multiple dose levels and send them back to you for testing.
Contact us and a Technical Services Representative will be in touch discuss your goal for your project and guide you with next steps.
We do not use “totes” to process our material. Rather, we have a conveyor system of flat, tabletop carts (4′ x 8′) on which we set the products in a single layer.
Wire, cable, tubing, and sheet products can be processed in a reel-to-reel configuration.
Right back at you: how many samples do YOU need for a material test? 😉 The quantity is based on what you (or your lab) will need to perform testing afterwards. Typically, though, customers will send us around 5-20 samples per dose.
E-BEAM Serivces has 5 world-class accelerators with over 700 kW of capacity. We are the largest contract electron beam service provider in the U.S. We process multiple truckloads of products on a daily basis.
Contact us with your specific volume needs, and we’ll discuss what this means for your products.
No, not for our 4.5-million-volt electron accelerators! In fact, some of the product we process are in cases that are almost 3 feet high.
Nope. Products are ready to leave our facility as soon as they are processed.
Trick question. There isn’t really a max dose restriction. Want 10 kGy? Got it. Want 1,000 kGy? Sure, we can do that too. We’ve even processed small samples at 2,000,000 kGy!
Check out this Crash Course for an overview of the sterilization product validation process.
The size of the box really depends on the product density inside. We process some boxes that are close to 3’ high, and others that can only be a couple of inches high. For a quick answer for your specific product, please contact us.
Yes, both our Ohio and New Jersey locations are licensed to process radioactive materials.
Yes, we process products from animal, plant, or human source. We offer cryogenic and refrigerated processing, as well as processing of individual units to meet the needs of the specific tissues.
E-BEAM Services is dedicated to providing uninterrupted priority sterilization services for products used for COVID-19 response, including test tubes and swabs used in kits to test for coronavirus. Here is a message from us to our values customers.
Inquiries can be sent to our Technical Services team directly here.
We provide sterilization services for swabs, test tubes, cryules, face shields, and ventilator components. Unfortunately, N95 masks are not suitable for sterilization using radiation services like e-beam or gamma.
The team at E-BEAM Services is committed to the health and safety of our community, including patients and healthcare workers. That means getting products that can help validated for sterilization as soon as possible. We have reserved validation and processing time specifically for COVID-19 response products, and will make a fast turnaround time a priority.
Questions regarding the reprocessing of medical devices should be directed to the FDA.
Questions regarding actual or impending medical device shortages should be directed to the FDA.