X-ray Sterilization for Medical Devices – The Future-Proof Technology
Today there are X-ray sterilization centers in Europe, Japan and North America and the first X-ray facility dedicated to Sterilization is operational in Europe.
Press Release - Leoni Studer Hard Website - LEONI Studer Hard, Pioneering X-ray Sterilization
One of the unique properties of X-rays is their narrow angular distribution concentrated in the direction of the product being sterilized and thus allowing excellent Dose Uniformity performances compared with other radiation technologies.
X-rays are an electrical powered technology which offers solutions to the Gamma industry issues such as supply, transport and disposal of Cobalt-60 sources.
Electricity is a common source of energy for the industry and is a safe choice for the future since it is widely available and increasingly made of renewable energies.
X-rays are therefore the logical sterilization technology which allows you to see the future with serenity.
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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.
| E-beam Boxes | X-ray Pallet | Gamma Pallet | Gamma Tote | |
|---|---|---|---|---|
| Dose Uniformity Ratio | Average | Excellent | Good | Excellent |
| Cost Efficiency | Excellent | Good | Good | |
| Dose Rate | Very High | Medium | Low | |
| Product Penetration | Low | Very High | High | |
| Labor Requirements | Labor Intensive | Labor Efficient | Labor Efficient | Labor Intensive |
| Safety | Irradiation Stops with power Off | Irradiation Stop not Possible | ||
| Source Energy | Electricity | Electricity | Cobalt 60 | |
| Market Adoption | Widely Adopted | New Technology | Widely Adopted | |
eXelis ® – The IBA Solution for X-ray Sterilization
IBA’s X-ray solution for Sterilization centers, eXelis®, is based on the Industry Proven Rhodotron® E-beam accelerators and an X-ray target. eXelis® makes X-ray sterilization competitive against medium size equivalent Gamma facilities.
eXelis® is a clean and safe technology which does not leave chemical residue in the product. There is no shipping, handling, use or disposal of radioactive material. eXelis® is a safe and environment friendly processing solution.
Modular Design for Reduced Costs
The modular design of eXelis® enables to adapt the cost of a sterilization center to your capacity needs. Pay only for the power needed and increase the system’s capacity by adding power modules when required with short downtime.
Excellent DUR with
Pallets
Products can be processed in their original packaging on full pallets. This leads to considerable savings in terms of processing time, treatment cost and storage space.
The excellent penetration properties of the X-rays lead to an improved Dose Uniformity Ratio eXelis® maintains this DUR around or below 1.25 for pallets while the ratio is of 1.45 in Gamma sterilization.
Modular Design for Reduced Costs
eXelis® configurations can be optimized to fit specific needs and expected volumes. You can start small and increase quickly the system capacity when needed.
Available eXelis® Configurations
| eXelis®-M 300 | eXelis®-M 1000 | |
|---|---|---|
| Power | From 40 to 420 kW | From 100 to 700 kW |
| Maximum Throughput (m³/year) (ft³/year) |
From 11,000 to 93,000 From 310,000 to 3,200,000 |
From 22,000 to 155,000 From 770,000 to 5,400,000 |
| Gamma Equivalent | From 310kCi to 3.2 MCi | From 770kCi to 5.4 MCi |
Throughtput assumptions: 25kGy, 8,000 hours/year, 7 MeV, pallets, 0.15gr/cm³
The cost of the X-ray generator in a sterilization facility can be compared with the initial Cobalt-60 loading of a gamma facility. In general the cost of an X-ray generator starts to be more economical from 1.5 MCi to 2 MCi depending on local electricity costs.
X-rays energy costs consist in electricity consumption which vary from region to region but in general yearly costs are much lower compared with Cobalt-60 decay in a Gamma facility. In order to reduce electricity costs, it is also possible to conceive a center which sterilizes only during the hours when electricity is cheaper.
Excellent DUR with Pallets
Wide energy spectrum and directive photons explain X-ray’s excellent penetration properties leading to unmatched DUR. This is critical when treating sensitive products.
These properties explain why X-ray sterilized products have excellent DUR of 1.25 while Gamma only reaches 1.45.
X-ray sterilization systems irradiate full pallet loads by moving them continuously in front of the X-ray source. The loads are irradiated on opposite sides as they pass in front of the X-ray target at both high and low elevations.
eXelis® is based on an incremental dose concept. Such an incremental sterilization solution combined with a single row of pallets in front of the X-ray target offers a very high level of flexibility when sterilizing a mix of different products.
One increment consists of four passes of the pallet in front of the X-ray target (Pallet irradiated from the top and bottom, front and rear side). The increment dose is the minimum dose the product can receive. Any multiple of the increment dose can be given to the product by adding increments (ie: if increments have a value of 5 kGy, 25 kGy can be given to the product with 5 increments)
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