validation and dose mapping...dose mapping is a core instrument to render a sterile product while...
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ValidationandDose MappingJosef Mittendorfer, Consultant
Seminar Copenhagen June 9th 2017
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Highly Appreciated Irradiation Service Provider since 1995
Three Technologies: E-Beam – Gamma – X-Ray
Devoted to Quality of Services and Innovation
TT-100 Rhodotron 10 MeV and TT-100 10 MeV/6.6 MeV E-Beam/X-Ray
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TT-300 “Duo” E-Beam “Workhorse” X-Ray “Special Products”
190 kW Power E-Beam: 10 MeV 19 mA X-Ray: 7 MeV 27 mA
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Fully Automatic
Pallet Layers on Trays
Separate E-Beam andX-Ray Process Conveyors
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Depalletizer/Palletizer Product Turning
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Medical Devicein its Shipping Container
Sterilized usingIonizing Radiation
Electron Beam
Medical Device Example
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Process Definition
Dster Minimum dose to ensure sterility
(Dose Setting)
Dmax,acc Maximum dose not
to harm the product
(Material Qualification)
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Electron Beam Treatment
Improve Penetration:
1st Pass2nd Pass
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020406080
100120140
0 2 4 6
Do
es
[%]
z [g/cm²]
Dose in PE-Foam Phantom
z=Depth g/cm²]= depth cm] x Density g/cm³]
Standardized
Depth: z
Build-Up
Region
Fast Drop Off
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Double Sided Treatment to Improve Penetration
Z=8.5 g/cm²
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ISO 11137-1 PQ Requirements
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Product Validation- Dose Mapping
Dosimeters are placed inside the product to locate
the minimum and maximum dose zones
Quantify: Dmin, Dmax, Dmon
Dmin Dose at Minimum Position
Dmax Dose at Maximum Position
Dmon Dose at Monitoring Position
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Mapping in General - in 2 Dimensions
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Dose Mapping 3-Dimensional
Evalulating dose in x-y-z inside the product:
Where ? Locations/Grid
How? DosimeterModelling
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DosimeterAlanine PelletsRadiochromic Films
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Dosimeter Placement
thin film dosimeter with poach(18- 50 m) with Al- pouch
Alanine PelletsCylinders R=2.4mmPlastic wrappingbarcoded
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Established in Medical Physics New Possibilities with CAD input Place Dosimeters/Object is Dosimeter Simulate Changes to Product/Process Study Dose Effects
Mathematical Modelling to assist Dose Mapping
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Visualisation - Example X-Ray Treatment
DUR 1.5DUR 1.5A … outer E … inner
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Example Shielding of Medical Devices
DUR 1.5
Mo 2 mm Mo 10 mm
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Deviation between Dose in Air and Dosimeter Measurement:
Pellet horizontal Pellet vertical. Film horizontal Film vertical-0.3% -2% -1.8% - 14.4%
Example: Dosimeter Response and Dose
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0.5mm Steel Wire in Tube
DUR 1.5DUR 1.5A … outer E … inner
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DUR 1.5
Steel Needle D=1mm Thickness 100µm
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DUR 1.5
Dose Mapping make synergistic use of:
Alanine Dosimeter ( averaging of microdose effects)
Mathematical Modelling (validated by experiments)to study and interpret radiation physics phenomena
No “hunt“ for dose gradientsUnderstand - Interpret – Assess Risk
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Routine Monitoring Position
On-Product – Position Laser Guided
Manual Placement
Automatic Removal
Alanine Dosimeter
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PQ Run Summary
Color Indication: Hot Spots – Low Dose RegionCold Spots – High Dose Region
Variation between Runs: RSDRSD <4% 4%<RSD <8%RSD > 8%
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Dose Mapping Summary
Dmin
Dmax
Dmon
Rmin/mon= Dmin/Dmon
Rmax/mon= Dmax/Dmon
DUR= Dmax/Dmin
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Designing the Process
Customer Requirements
Dster
[kGy] 25
Dmax, acc
[kGy] 40
Process
Dster
Dmax,acc
Process Parameter:I,v,s
Dmon/lower,Dmon/upper]
Uncertainties: Dose Mapping (R-factors), Machine, Dosimeter
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Dmonster 15.4 kGy Dtarget
lower=16.2kGy Dtargetupper=18.6kGy Dmon
max,acc 19.1 kGy
Setting Target Dose (taking into account uncertainties)
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Dster=25kGy Dmin=27.7kGy Dmax=35.6kGy Dmax,acc=40kGy
Product Doses
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Dose vs. Process Parameter
D Dose in kGy
I Beam Current
v Process Speed
s Scan Width
k= De(0)*F
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Surface Dose – Beam Parameter Relationship
0
10
20
30
40
50
60
70
16 16,1 16,2 16,3 16,4 16,5 16,6 16,7 16,8 16,9 17 17,1 17,2 17,3 17,4
FREQ
UEN
CY
DOSIS [KGY]
Reference vs. Parametric Doses
Reference Dosimeter Machine Doses
Reference Dose:
RSD 1.4 % (k=1)
Parametric Dose:
RSD 0.5 % (k=1)
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Product Batch Control Chart
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Long Term Reference Dose Analysis
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CONCLUSION
Dose Mapping is a core instrument to render a sterile product while sparing product from harm bypreventing overdosing
A fine-tuned, robust method, state-of-the-art dosimeters and advanced modelling are vital in achieving this goal