The BeamOne electron beam sterilization process, first commissioned in 1993, was designed specifically for the needs of the medical device industry. To this end, BeamOne equipment incorporates engineered control and product handling features which provide optimal levels of dose assurance and process integrity.
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› Pre-Set Equipment Parameters
The critical linear accelerator and processing parameters which control proper dose application and equipment functioning are pre-established by equipment engineering technicians. Production personnel operating the equipment on a daily basis have no access to these parameters and cannot alter them during routine production. Should a malfunction cause the equipment to drift out of parameter tolerance, the factory control system will automatically record a fault and interrupt the process. This requires an immediate investigation into the cause of the fault, correction, and restart of the system, thereby continuing the sterilization process. While this control feature ensures that products processed meet the requirements for parametric release, dosimeters are still used to provide an actual absorbed dose measurement.
› Patented Process Interrupt System
In the event of a processing interruption, the conveyor system and the linear accelerator stop simultaneously, and BeamOne’s validated process interrupt mechanism is activated. This patented process incorporated into BeamOne systems ensures that, upon resolution of any machine shutdown, the linear accelerator and electron beam will begin to function a fraction of a second prior to the start of conveyor movement. The process interrupt system ensures that no part of the product carton is left unprocessed due to a system fault. The section of the product in front of the beam at the point of shutdown/restart receives a positive dose contribution prior to the re-start of carrier movement.
› Precise Product Qualification Studies
When qualifying product for routine production, BeamOne undertakes a highly detailed study of the dose distribution within a product box. During the Dose Map study, product overshipper boxes as well as inner packaging are opened. Dosimeters are placed on product throughout the container to measure the exact doses of radiation delivered to critical areas within the box and within the product’s unique package configuration. This study provides precise dose definition within the shipping container and allows for accurate correlation to the external reference dose monitoring position utilized during routine processing.
› Horizontal Beam Direction
The actual electron beam is a series of rapid pulses of energy, with each pulse delivering a “beam spot” approximately 2 inches in diameter. The electron beam is directed horizontally at the product and scans up and down over the product cases, in contrast to most electron beam systems which direct the beam down into the box from an overhead beam source. This horizontal beam orientation allows the entire process carrier containing product cases to be rotated 180 degrees so that the second side of the product can be processed. Rotation of the entire carrier assures that contents of the boxes are not mixed or unseated and supports the dose control consistency established through the original dose mapping process. The engineering control of this rotation is assured, while other systems rely on an operator to manually turn boxes on the conveyor before their re-entry into the system.
BeamOne’s horizontal beam orientation allows for 180° rotation of the product carrier and eliminates the need to manually turn or unseat product boxes.
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