What Quality Systems are applicable for electron beam sterilization?
E-BEAM Services’ Quality Systems 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, so we assure compliance with the EU Guidelines to Good Manufacturing Practice for Medicinal Products and the […]
Will crosslinking increase my plastic part’s chemical resistance?
You might remember from high school chemistry class that solubility is increased by chemical similarity between solute and solvent. Plastics will be most vulnerable to chemicals in which it is soluble. Therefore, you can tailor your choice of plastics so that it is resistant to a specific class of chemicals, or –very efficiently — increase […]
How can I lower the cost per foot when processing reel-to-reel products?
Part 1: Why more material on a reel will result in a lower cost Sometimes more is better. More vacation days, more good weather, and, in my personal opinion, you can’t go wrong with more bacon cheesefries. The same principal also applies to the amount of material on a reel sent to us for e-beam […]
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.
Do I have to build a certain pallet load for the e-beam process?
The quick answer is NO!Unlike other sterilization methods, such as EtO and gamma, the e-beam process unloads pallets and places cases of product onto conveyer carts in a single layer.
What is crosslinking?
Crosslinking plastics, using e-beam processing, creates excellent property improvements. But just what is crosslinking? If you want the technical definition (which may make your eyes glaze over) it is:
How is a sterilization dose measured in the e-beam irradiation process?
Are you ready for the shocking truth? Truth is, we can’t actually guarantee sterility of any products we “sterilize.” Don’t panic just yet though! We are fully capable of certifying the dose the product received—the dose that you and your microbiological lab determined was needed to qualify your product as sterile.
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 […]
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.” […]
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 […]