Ionisos Ibérica - Medical services
Sterilization of packaging by radiation for medical, health and veterinary sector: alternative to the ethylene oxide (ETO)
Ionisos Ibérica, leader in the field of sterilization, is the leader of service to others, dedicated among others, sterilisation by ionising radiation (accelerated electrons) of containers for subsequent filling in clean room.
Experience and professionalism of 15 years in the field of sterilization of health care products, as well as the resources both material and human to offer a personalized service, able to meet the needs of the client at a competitive cost and complying with the most demanding standards specifications: GMP´s, EN-ISO 9001; EN-ISO 13485; EN ISO 11137 - 1 - 2 - 3, FDA, Royal Decree 1591 / 2009 that regulates medical devices, and the Royal Decree 1616 / 2009, of 26 October, which regulates medical devices implantable assets.
Process: The product reaches to Ionisos facilities in their final packaging.
During the process, containers, are exposed to the action of the electron beam for a short period of time, the necessary so that they absorb enough energy to reach the desired assurance level. Once treated, the expedition can be immediate.
Advantages:-physical method, sterilization, generated by electricity, not used nor generates chemicals or toxic.
-Method fast, reliable, flexible and compatible with most plastics and raw materials.
-Well documented process, with absolute for every type of product traceability.
-Treatment without quarantine. Possibility of immediate use.
-Applicable legislation and simple validations.
-Process of moderate temperatures, clean and treatment delicate, valid for all types of product and without the need for special packaging.
-Intrinsic safety.
-Economic process of excellent performance.
-With each treatment, a detailed certificate issuance.
Iberian Ionisos Advisor for the achievement of the CE mark to medical and health products.
Experience and professionalism of 15 years in the field of sterilization of health care products, as well as the resources both material and human to offer a personalized service, able to meet the needs of the client at a competitive cost and complying with the most demanding standards specifications: GMP´s, EN-ISO 9001; EN-ISO 13485; EN ISO 11137 - 1 - 2 - 3, FDA, Royal Decree 1591 / 2009 that regulates medical devices, and the Royal Decree 1616 / 2009, of 26 October, which regulates medical devices implantable assets.
Process: The product reaches to Ionisos facilities in their final packaging.
During the process, containers, are exposed to the action of the electron beam for a short period of time, the necessary so that they absorb enough energy to reach the desired assurance level. Once treated, the expedition can be immediate.
Advantages:-physical method, sterilization, generated by electricity, not used nor generates chemicals or toxic.
-Method fast, reliable, flexible and compatible with most plastics and raw materials.
-Well documented process, with absolute for every type of product traceability.
-Treatment without quarantine. Possibility of immediate use.
-Applicable legislation and simple validations.
-Process of moderate temperatures, clean and treatment delicate, valid for all types of product and without the need for special packaging.
-Intrinsic safety.
-Economic process of excellent performance.
-With each treatment, a detailed certificate issuance.
Iberian Ionisos Advisor for the achievement of the CE mark to medical and health products.
