E-beam and X-ray Symposium
June 12-13, 2015
Benoit Mullier
IBA Industrial
E-beam and X-ray solutions
Comparison with other technologies
Sterilization
Definitions

Validated process used to render product free from
viable microorganisms.
Note : In a sterilization process, the nature of microbial inactivation
is exponential and thus the survival of a microorganism on an
individual item can be expressed in terms of probability. While this
probability can be reduced to a very low number it can never be
reduced to zero
ISO 11137 Standard
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Single Use Medical devices
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Single-Use Medical devices
Market growth : 5%

Single-use medical devices growth is 5.6% per year
Growth
• Wound/injuries (top-selling)
4.7 %
• Nonwoven
4.4 %
• Diagnostic & lab
7.1 %
The Freedonia Group
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Sterilization Methods
Thermal
Chemical
Radiation
g
b
Steam - Autoclave
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X
Ethylene Oxyde
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• Gamma
• E-beam
• X-ray
Sterilization Methods
Market Shares
Electron
Beam
10%
X-ray
<1%
E-beam/X-ray grows 2x faster
than global sterilization market
Oxyde
d’Ethylene
49%
Gamma
40%
Single-use medical devices – Sterilized volumes
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Sterilization Methods
Which method ?

Device resitance to treatment constraints



Temperature
Humidity
Radiations

Investment costs

Treatment cost /m³



Volume
Operational costs (electricity, manpower)
Logistics / Packaging (In-Line / In-house / Outsourced )
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Global Trends
Single-use medical devices
Increased regulatory pressure on sterilization processes
based on chemical and radio-active sources
accelerate adoption of Electron beam and X-ray sterilization processes
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Irradiation Sterilization

Products exposed to a controlled quantity of
ionizing energy.
 Dose [kGy]

Damage to DNA of living cells
 Cells cannot reproduce.

Modification at the peripheral electrons; no interaction
with the nucleus.
 No product activation
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Irradiation : Penetration
Better Penetration
Bigger Packaging
Better Quality
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Irradiation : Methods Comparison
Same technologies from a radiation point of view
E-beam
X-ray
Gamma
Gamma Rays
E-Beam
E-Beam
accelerator
accelerator
III
III
Cobalt 60
Electron –>
X-Ray Converter
E-Beam
Key Differences
Source: electricity vs Cobalt-60
Directional vs Isotropic
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On/off
vsand
continuous
irradiation
X-rays
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GAMMA
Cobalt 60

Benefits



Drawbacks



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Penetration
Treatment quality
Radioactive source
Continuous
Poor flexibility
IBA Solutions
1
E-beam
eXelis
Rhodotron Duo
10 MeV E-beam
5 or 7 MeV X-ray
Boxes
Pallets
10 MeV E-beam
+ 5 or 7 MeV X-ray
Boxes
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E-BEAM
1
Treatment Parameters
E-Beam accelerator
2
3
E-Beam
Energy
1

Penetration
Current
2

Treated volumes
Scan
3

Product width
Speed
4

Treatment time
4
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E-BEAM
Penetration
10
E-beam Limit : Regulation
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E-BEAM
Penetration
8.3 cm
3.7 cm
Single side
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Double side
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E-beam
Throughput
Energy
Power range
TT100
TT200
TT300
TT1000
10 MeV
10 MeV
5, 7, 10 MeV
5 or 7 MeV
Up to 40kW
35 to 100 kW
35 to 420 kW
100 to 560kW
68.000 m³/y
168.000 m³/y
700.000 m³/y
N/A
2.3 Mci
5.8 Mci
24.3 Mci
Max throughput
• 10 MeV E-beam
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E-BEAM

Benefits





Drawbacks



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Efficiency
Electricity based
On/Off
Flexible
Penetration
Quality if non-homogeneous
Investment
E-BEAM
Treatment center
Loading
Rhodotron
Irradiation
Flipping
Second pass
Unloading
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IBA Solutions
E-beam
2
X-ray - eXelis
Rhodotron Duo
10 MeV E-beam
5 or 7 MeV X-ray
Boxes
Pallets
10 MeV E-beam
+ 5 or 7 MeV X-ray
Boxes
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X-RAY
X-ray
X-ray
Accélérateur E-beam
Max :
- 7 MeV Medical
- 5 MeV Food
Efficience : ~ 10 %
Electron –> X-Ray Converter
X-rays
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Dose Uniformity Ratio (DUR)
Ideal DUR = 1 (Dmax = Dmin)
Better DUR means:
-> less overdose
-> less impact on products
-> possible to treat products previously
only sterilizable with EO
Data source:
Synergy Däniken (Swizerland)
X-ray processing site
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Throughput
Throughput is proportional to accelerator power
(40 – 700 kW)
Typical throughput range
Up to 20 m³ / h
For Medical Devices (0.15 g/cc)
Data source:
Synergy Däniken (Swizerland)
X-ray processing site
Throughput for a large size solution (560kW)
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X-ray
Throughput
Energy
Power range
TT100
TT200
TT300
TT1000
10 MeV
10 MeV
5, 7, 10 MeV
5 or 7 MeV
Up to 40kW
35 to 100 kW
35 to 420 kW
100 to 560kW
68.000 m³/y
168.000 m³/y
700.000 m³/y
N/A
2.3 MCi
5.8 MCi
24.3 MCi
8.000 m³/y
22.000 m³/y
93.000 m³/y
124.000 m³/y
280 kCi
770 kCi
3.2 MCi
4.3 MCi
Max throughput
• 10 MeV E-beam
• 7 MeV X-ray
0.15 gr/cc, 8000 hours/year, 25kGy
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Rhodotron – Power Modularity
Up to 200kW
Up to 420kW
Up to 700kW
Power Supplies
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X-RAY
eXelis configuration

Benefits






Drawbacks


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Penetration
Treatment Quality
Flexible
Electrically powered
On/Off
Consumption
Investment
A Typical dedicated X-ray Center
http://www.iba-sterilization.com
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Our Vision: X-ray is THE alternative to Gamma

We believe the future of Gamma Sterilization is uncertain:




Supply issues
Increasing transport restrictions
Global environment considerations increasing
We believe that X-ray Sterilization is the alternative to Gamma
because:



Equivalent or better Quality
Electrically powered, electricity is the energy of the future increasingly
produced through renewable energy sources
No product or packaging changes required when switching from Gamma
to X-ray sterilization
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IBA Solutions
E-beam
X-ray - eXelis
10 MeV E-beam
5 or 7 MeV X-ray
Boxes
Pallets
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3
Rhodotron Duo
10 MeV E-beam
+ 5 or 7 MeV X-ray
Boxes
Rhodotron DUO
Service center : Dilemma
Typical product split
E-beam Compatible
10 MeV E-beam
Out-sourced / Refused
Too thick – Too dense
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Rhodotron DUO
Service center : Dilemma
Typical product split
10 MeV
E-beam
7 MeV
X-ray
E-beam compatible
Too thick – Too dense
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Rhodotron DUO
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Rhodotron DUO
We believe
Electron beam is the most cost efficient technology for many
Disposable Medical Devices
For other Medical Devices, X-ray Sterilization is the best alternative
to Gamma :
Rhodotron DUO = The best of the 2 worlds
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Rhodotron product range
TT100
TT200
TT300
TT1000
10 MeV
10 MeV
5, 7, 10 MeV
5 or 7 MeV
Power range
Up to 40kW
35 to 100 kW
35 to 420 kW
100 to 560kW
Diameter * Height
1.6 * 1.7 m
3 * 2.4 m
3 * 2.4 m
3 * 3.4 m
68.000 m³/y
168.000 m³/y
700.000 m³/y
N/A
2.3 MCi
or
5.8 MCi
or
24.3 MCi
or
8.000 m³/y
22.000 m³/y
93.000 m³/y
124.000 m³/y
280 kCi
770 kCi
3.2 MCi
4.3 MCi
Energy
Max throughput
• 10 MeV E-beam
• 7 MeV X-ray
0.15 gr/cc, 8000 hours/year, 25kGy
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Is X-ray efficient? Money talks!
Energy efficiency comparison
Cost of energy for sterilizing 1 m³
For 64.000 m³ / y throughput pallet
configuration
For 124.000 m³ / y throughput pallet
configuration
12,0
10,0
1,7
8,0
8,5
1,8
9,1
Cost HIGH
6,0
4,0
Cost LOW
0,6
4,1
2,0
0,0
Energy costs (€)
Energy costs (€)
12,0
10,0
1,8
9,1
8,0
1,4
6,0
6,5
Cost LOW
4,0
2,0
Cost HIGH
0,4
2,4
0,0
E-beam
X-ray pallet Gamma pallet
E-beam
X-ray pallet Gamma pallet
Assumptions
Electricity range : 0.08 – 0.1 €/kWh
Co-60 range: 2.5 – 3 CAD/Ci
X-ray & Gamma pallet configuration, 25 kGy
2.8 MCi = 38 kW E-beam = 300 kW X-ray = 64.000 m³/y
5.5 MCi = 80 kW E-beam = 560 kW X-ray = 124.000 m³/y
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Includes E-beam and X-ray maintenance costs
Excludes Gamma surrounding costs (transport, waste mgmt, …)
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Source acquisition costs
X-ray vs Gamma Investment Model
Gamma
X-ray
Crossover point
Accelerator
Irradiator
0
200
400
Power (kW) / Activity (Mci)
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600
800
Conclusion
2 technologies of the future
E-beam
X-ray
to face 2 well-established but risky technologies ,
Gamma
Based on 3 solutions
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EtO
THANK YOU
Great Team !