Frequently Asked Questions (FAQ)

E-BEAM Services’ Quality System meets the requirements set out by the US Food and Drug Administration (FDA), and our facilities are registered and audited by the FDA. We also work with customers that market their products in Europe (as well as other parts of the world), so we assure compliance with the EU Guidelines to Good Manufacturing Practice for Medicinal Products and the European Council Directive Concerning Medical Devices.

There are two sets of FDA standards, one for Medical Devices (21 CFR Part 820) and one for Drugs, (21 CFR Parts 210 and 211). The FDA also recognizes two Industry Standards and expects compliance with them. The first is ISO 13485 certification, covering Quality Management Systems for Medical Devices, and the other is ISO 11137, which deals with Sterilization of Health Care Products using radiation.

In order to ensure ISO medical device compliance with these standards, E-BEAM Services sterilizes in accordance with International Standards for the operation of our equipment, dosimetry systems, and product qualification. E-BEAM is audited by a third party registrar — to provide an independent assessment of our Quality Management System.

ISO 13485:2016 – Lebanon, OH, and Cranbury, NJ facilities

Of course! We love to meet our customers in person. Contact us to arrange a visit.

No. In some circumstances, however, we can provide an hourly rate for specialty processing. Reach out to your Tech Services representative for a quote.

Yes. We ask that our customers make the shipping arrangements.

Yes, our Ohio facility is licensed to sterilize Class III narcotic and non-narcotic controlled substances.

Yes, if you want to be approved for Net 30 terms. Otherwise, no you don’t – we also accept payment via check, wire transfer, ACH, and credit card. Surcharges may apply.

Yes. There is a 5% surcharge. We also accept payment via check, wire transfer, ACH, or you can complete a credit application for Net 30 terms.

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.

No, we don’t, we supply the dose exposure. We can, though, provide you with contact info for several labs that can perform the testing.

No, we choose not to process generic pharma at this time.

Yes. Please email OhioShipping@ebeamservices.com or 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.

No, we do not process food at our facilities. We do, however, accept gifts of food. Preferably chocolate.

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’ll start off with a material test, during which we’ll process several samples of 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) to test for degradation.

Minimum dose is usually determined through bioburden testing with your microlab in accordance with the sterilization regulatory standards.

There are several factors that go into determining the proper surface dose for your product, including the materials used and desired outcome (performance enhancement or sterilization). We will determine the exact surface dose range needed to properly process your product through material tests and dose distribution studies.

We’ll start off with a material test, during which we’ll process several samples of 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) to test for degradation.

If your product has been validated with us, you will schedule with the customer service manager for the facility your product will be processed at. Email us at ebeam@ebeamservices.com if you aren’t sure who your contact is.

If your product hasn’t been validated (or if you’re not quite sure what that means…) then contact us to speak with a Technical Services Representative.

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 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.

We ask that customers provide a return shipping label for cases of product, or schedule freight if needed. Please note that we cannot ship via USPS, FedEx Ground, or FedEx Home Delivery.

E-BEAM Serivces has 4 world-class accelerators with over 600 kW. We are the largest contract electron beam service provider in the U.S. We specialize and are experienced in processing large volumes of product 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 is in cases that are almost 3 feet high.

Nope. Products are ready to leave our facility as soon as they are processed.

The office is open Monday through Friday, 8:00-5:00 pm.

With credit approval, our terms are Net 30.

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.

It would be easier to tell you what kind of products e-beam can’t improve! Check out this Crash Course for more info.

Contact us, and a Technical Services Representative will send you several forms to review: New Customer Information, Experimental Terms

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, email us at ebeam@ebeamservices.com with the dimensions and weight of your box.

Standard production turnaround time is based on your frequency, volumes, and specific processing needs.

We have two locations qualified for sterilization and crosslinking, one in Lebanon, Ohio and one in Cranbury, New Jersey. We also have a location in Lafayette, Indiana to serve your small diameter reel-to-reel product needs.

https://ebeamservices.com/about-us/facilities/

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