In this unlikely case the validation could be based entirely on historic data.
E beam sterilization canada.
Bottles septa are routinely being produced using a radiation sterilization process and for which accurate and complete materials process and test data exists.
E beam services facilities are state of the art and are located in lebanon ohio cranbury new jersey and lafayette indiana.
The beam a concentrated highly charged stream of electrons is generated by accelerators capable of producing continuous or pulsed beams.
Safeguarding global health with every product we sterilize.
Covid 19 sterilization e beam sterilization.
August 3 2020 sotera health s sterigenics announces acquisition of iotron industries.
The electron beam e beam irradiation process uses high energy electrons for a variety of applications such as the sterilization of single use medical devices contamination control of consumer products and modification of materials such as heat shrink tubing wire and cables and molded parts.
Electron beam sterilization product testing dosimetry dose mapping and dose validation studies to manufacturers in baja california.
The electron beam process can achieve widely differing effects such as sterilization polymer modification crosslinking and chain scission via its action as an ionizing radiation.
As the product material being sterilized passes the e beam energy from the electrons is absorbed altering various chemical bonds damaging the dna and destroying the reproductive capabilities of the microorganisms.
3 3 retrospective validation applies when existing products and or raw materials or supplies e g.
Projects can vary from the supply of a linear accelerator linac up to the integration of a validated irradiation system including a conveyor system process management automation and radiation shield design.
Sterigenics is the global leader in comprehensive sterilization solutions serving customers industrial sterilization needs across the medical device pharmaceutical advanced applications commercial and food industries.
In its simplest terms the bombardment of a material with high energy electrons results in a cascade of these electrons moving through the target material.
Iotron industries global leaders in electron beam e beam sterilization cross linking chain scission material improvement curing pest pathogen control.
Mevex is a manufacturer and supplier of integrated sterilization equipment with a range of equipment and services from e beam x ray ethylene oxide eto conveyors and robotics to meet customized needs.
