IBA’s X-ray solution for Sterilization centers, eXelis® Sterilization , is the ideal alternative for medium to large Gamma Sterilization centers. Compared to Gamma irradiation techniques, X-ray Sterilization offers shorter product turnaround times, deeper penetration and is less harmful to products requiring a short exposure time.
The illustrated eXelis Sterilization solution is based on an incremental principal whereby the pallet containing the medical devices receives a dose of 2 kGy per complete treatment. Customers then decide on the number of doses to apply to a particular product. Such an incremental sterilization solution offers a very high level of flexibility when sterilizing a mix of different products.
eXelis is available in configurations from 11.000 m³/year (0.4MCi) up to 125.000 m³/year (4.5MCi).
The room where is located equipment such as compressed air unit, water cooling tanks, ...
The engine of the eXelis solutions is the industry well known Rhodotron.
The Rhodotron type and power will be chosen depending on the throughput requirements of the sterilization center.
X-rays are produced by intercepting the Rhodotron accelerated electrons with a tantalum target.
The key difference with Gamma is that X-rays are concentrated in one signe direction allowing a faster sterilization time.
Pallets are guided through the facility thanks to the conveyor.
The conveyor is optimised to balance the performances and the flexibility: the product is overlapping the source of photon.
A wall of 3x2 pallets is capturing a large part of the photon flux produced by a vertical X-ray converter.
The speed of the conveyor is tuned to transfer the dose to the product by increments of 2kGy.
Is the interface to the sterilization center for the workers.
Medical device can be treated directly in their original pallet packaging without any additional labour required for packaging modification.
In order to assure an excellent DUR, a complete pallet increment represents four passes in front ot the X-ray target at different positions (pallet up, down, front, back).
The upside down station handles this move of pallets.
Starting, stopping production, changing sterilization parameters are performed from this location.
Practically, the penetration will depend on the density of the material considered.
At equal material density, X-ray offer better penetration compared with Gamma.
Test and simulations show that DUR's of less than 1.4 can be achieved for medical devices with densities of 0.15 in their original industrial pallet packing. The DUR is maintained below 1.5 for density up to 0.3g/cm3.
The figures for the minimum and maximum dose in each horizontal plan for a 0.1g/cm3 pallet, when surrounded by 0.1 or 0.2g/cm3 pallets, did not show any significant impact between maximum and minimum dose per layer and the global DUR stayed the same.
eXelis Sterilization centres are offered in several configurations up ti 125.000 m3 of sterilized medical devices per year.
For a standard dose of 25kGy, with 0.15g/cm3 of density, on an 8,000 hours per year basis, the eXelis system can treat 124,000m3 or 4,4 million cubic feet.
Based on the traditional 1 MCI ~ 1 million cubic feet per year conversion factor, the X-ray facility would be equivalent to a 4.4 MCi totes gamma facility, or to a 5.5 MCi pallet gamma system.
The mentioned throughput of 125.000 m3 / year would increase if we assume lower dose requirements (for example 18kGy) or lower product density (for example 0.1g/cm3).
Smaller eXelis throughputs are also available.
Not like Gamma rays, eXelis X-rays are all concentrated in one direction allowing record product treatment time.
The treatment can be ran in small to medium size batches, there is therefore no need to fill the irradiation area with a huge number of product carriers or to process products in large quantities.
There are no delays for sorting products by dose of dwell time requirements, or for inserting blank pallets between batches.
For the costs of a 3.5MCi Gamma facility, eXelis sterilizes as much medical devices as a 4.5MCi Gamma facility.
When calculating the sterilization cost per unit, figures show 10 to 20% saving for X-ray sterilization compared with Gamma.
The physical properties of X-rays are best suited for sterilizing medical devices on pallets.
Sterilizing medical devices in their original pallet packing allows by-passing heavy de-palletization and re-palletization processes.
This is a strong cost reducing in operating expenses for sterilization facilities.
Cobalt's future is uncertain; transport and disposal of radioactive sources are more and more difficult to manage because of regulations becoming tougher every year.
The logical future Sterilization technology is based on electricity.
An electricity based eXilis' solution allows customer to see the future with serenity.
Forecasting Cobalt needs is not an easy task.
It needs to be done well upfront and mistakes in sush predictions have non-negligible impact on the company's profitability.
If the forecast in Cobalt fill-up was too optimistic, the sterilization costs will increase. If the Cobalt forecast was too pessimistic, the Gamma center will lose revenues since it will not be able to sterilize customer products.
Cobalts decay is a fixed cost not adaptable to production needs.
With X-ray, electricity needs are proportional to production requirements. No need to be a forecasting guru anymore.
During economical downtums your electricity costs will decrease and in case strong unexpected demand you simply need to turn the buttom.
© IBA 2009 | All rights reserved |
