Sterilization of medical devices
E-beam and X-ray sterilization: Sustainable alternatives to radioactive and chemical sterilization
Rhodotron® E-beam sterilization
E-beam sterilization is the most efficient technology for low density medical devices packaged in boxes.
- From 35.000 to 415.000 m³/y
- Sterilization in seconds
- Cost efficient: about 6 times more efficient than gamma sterilization
- Limited penetration properties suited for low density products or box packaging
- Supplies meet applicable ISO 11137 and ISO 9001:2008 requirements
Other applications compatible with this configuration:
EXPAND∨
Available configurations:
-
TT50
up to 35.000 m³
of boxes/year -
TT100
up to 70.000 m³
of boxes/year -
TT200
up to 170.000 m³
of boxes/year -
TT300
up to 415.000 m³
of boxes/year
eXelis® X-ray sterilization
X-rays offer unmatched sterilization quality with reduced overdosing compared with any other radiation technology. High power X-rays are also the ideal alternative to gamma sterilization.
- From 9.000 to 125.000 m³/y
- Modular design: start small and increase power when needed
- Excellent Dose Uniformity typically of 1.3
- Cost efficient: up to 2 times more efficient than gamma sterilization
- Highest penetration properties suited for pallet processing
- Supplies meet applicable ISO 11137 and ISO 9001:2008 requirements
Other applications compatible with this configuration:
EXPAND∨
Available configurations:
-
TT100
up to 9.000 m³
of pallets/year -
TT200
up to 22.000 m³
of pallets/year -
TT300
up to 55.000 m³
of pallets/year -
TT1000
up to 125.000 m³
of pallets/year
Rhodotron® duo
Benefit from the high efficiency and short payback period of 10 MeV E-beam sterilization with the possibility to offer 7 MeV X-ray sterilization services. Acquisition and operational costs are compressed to a minimum with this concept using one accelerator and one conveyor.
- Flexible power allocations: star small with X-ray and benefit from E-beam's fast ROI
- Compressed investment costs: it only takes about 15% more to build a dual technology faciliy
- Reduced operation cost: One accelerator, One treatment room, One conveyor
- Excellent Dose Uniformity using X-ray, typically of 1.3
- Supplies meet applicable ISO 11137 and ISO 9001:2008 requirements
Other applications compatible with this configuration:
EXPAND∨
Available configurations:
-
DUO 100
up to 40 kW* -
DUO 200
up to 100 kW* -
DUO 300
up to 245 kW* -
DUO 1000
up to 560 kW*
* Power installed on E-beam can be different from X-ray power
Process control
Managing your process
IBA’s process control system manages all equipment involved in the treatment process, including 3rd party equipment.
- Management of production orders and recipes
- Integration of 3rd party conveyor
- Coordination of equipment parameters (beam, conveyor and safety systems)
- Traceability
- Generation of treatment reports
- Supplies meet applicable ISO 11137, GAMP, 21CFR part11 requirements