11/01/2013

Herotron E-Beam Service GmbH

Sterilizing of medical devices and packing material

The so-called Tip-Trays with pipette tips by CyBioAG, Jena, are sterilized at Herotron (Photo: Herotron)
Compared to other procedures (steam, ethylene oxide or gamma irradiation), sterilization with accelerated electrons is far more environmentally compatible and economic.


For almost ten years, Herotron E-Beam Service GmbH has been working as service provider for the industrial treatment of materials via accelerated electrons. The company operates a facility at Bitterfeld-Wolfen with two high-performance electron accelerators. Both machines are used for the specific modification of plastic material as well as for sterilization of medical devices and packing material.


Like the production of medical products, sterilization is also subject to strict regulations. Accordingly, since March 2012, Herotron is certified to DIN EN ISO 13485 (quality management systems for medical devices) as well as DIN EN ISO 11137 (sterilization of products for health care). Ever since, the business sector “Medical Device Sterilization” has developed to be the most important main pillar of the company.


The electron beam sterilization is considered as the safest and most efficient procedure to make microorganisms and DNA fragments ineffective, respectively eliminate them. Compared to other procedures (steam, ethylene oxide or gamma irradiation), sterilization with accelerated electrons is far more environmentally compatible and economic.


Electron sterilization, also referred to as beta radiation, is applied for example to


Medical products, medical devices and implants,Medicine and pre-filled syringes,Grocery and pharmaceutical packing material,Laboratory devices and single-use material orCleaning material for sterile areas (wiping clothes, cleaning clothes).


The products are treated under normal environmental conditions in their bacteria-proof primary packing inside a box. Here a permanent sterilization happens which qualifies this procedure for products with complicated geometries.


This process happens without any chemicals which means no residues on the products have to be feared; degassing is also not necessary. The treatment only takes milliseconds to seconds where the material to be sterilized only warms up minimally. This way, thermolabil or deep-frozen products can also be safely sterilized. Hereafter, the products can immediately be put on pallets without any waiting time and prepared for delivery.


As full service provider for sterilizing via electron beams, Herotron supports their customers over the whole process chain, this especially in respect to the prescribed validation. This is documented proof that the procedure corresponds to the defined specifications and quality characteristics, which means the products are sterile.


The requirements to a beam sterilization are regulated and thus the validation in DIN EN ISO 11137. Accordingly, the procedure is to be validated in three steps:


The microbiological validation serves the determination of the beam dose. Here, Herotron provides its experience in cooperation with independent, certified partners.The dosimetric validation serves for the determination of the dose distribution considering the packing and the pack scheme. This is Herotron’s core competence.The consequent applied technical validation happens by the producer and serves as proof that the sterilized product functions as recommended. Here Herotron can give support, especially regarding the selection of packing material.


Altogether, sterilizing via accelerated electrons is completely residue and waste-free, very fast and efficient. Due to the short processing times, beam sterilization can optimally be integrated in the customers’ just-in-time logistic. After the products have run through the irradiation machine they can immediately be put on pallets and prepared for transportation. In this context, the conveniently situated location of the company directly at the A9 and not far from the logistic infrastructure hub Leipzig is an advantage for the customers.


Contact


Herotron E-Beam Service GmbH


Guardianstraße 6-10


06766 Bitterfeld-Wolfen


Tel +49 3494 6666-0


Fax +49 3494 6666-118


Mail info@herotron.com


www.herotron.com


www.herotron-medical.de


Contact Medical Device Sterilization:


Dr. Jörg Billhardt


joerg.billhardt@herotron-medical.de


Contact Material Modification:


Yves Kaufhold


kaufhold@herotron.com


Hinweis für die Redaktionen


Den Text dieser Presseinformation sowie das Bild in einer druckfähigen Auflösung können Sie unter www.herotron.com herunterladen.
Redaktioneller Kontakt und Belegexemplare: Redaktionsbüro Thomas Schwachulla, Lise-Meitner-Straße 3, 04178 Leipzig; Telefon: +49 341 60 452 552
E-Mail: thomas.schwachulla@web.de,