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 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, which covers Quality Management Systems for Medical Devices, and the other is ISO 11137 which deals with Sterilization of Health Care Products using radiation.


Standards used in the sterilization of health care products
Standards used in the sterilization of health care products

In order to ensure 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. Certificates are issued when compliance is achieved. These certificates are available on the E-BEAM Services website.

You can be assured products processed by E-BEAM Services will conform to the Regulatory Requirements established by law and statute.

Karen with Signature III




www.ebeamservices.com • Ohio (513) 933-0031 • New Jersey (609) 655-7460