1. Commissioning is no longer what it used to be: Installation and Operational Qualification (IQ/OQ) for an Electron Beam Plant
Florent KUNTZ1, Benoît MULLIER2, Hervé MICHEL3
1 Aerial-CRT, Illkirch France
2IBA, Louvain la neuve, Belgium
3Synergy Health, Däniken, Switzerland

2. Outline Introduction - Relevant standards/guides
Description of a standard process
Installation Qualification tests
Operational Qualification tests
Example of IQ results
Example of OQ results
Conclusion

3. Introduction – Relevant standard/guides
ANSI/AAMI/ISO :2006
ANSI/AAMI/ISO :2006
ISO/ASTM 51649:2005
ASTM E
Installation Qualification
To demonstrate that the irradiator has been supplied and installed in accordance with its specifications
Operational Qualification
To demonstrate that the irradiator, as installed, is capable of operating and delivering appropriate doses within defined acceptance criteria
Sterilization of health care products—Radiation—
Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Part 3: Guidance on dosimetric aspects

4. Description of a standard process
Installation Qualification Tests 1
ENERGY/CURRENT
(8.2)
(8.6)
(8.5)
ANSI/AAMI/ISO :2006
ISO/ASTM 51649:2005
SPOT SIZE 2
SCAN WIDTH 3
SCAN UNIFORMITY
PARALLELISM* 4
* optional
PRODUCT CENTERING 5
CONVEYOR SPEED 6

5. Operational Qualification Tests
Homogeneous material (various densities)
ANSI/AAMI/ISO :2006
ISO/ASTM 51649:2005
ASTM E
Dose distribution
Surface (9.3.4)
Product Height dependence (9.3.5)
Inside material (side effect, material effect) (9.3.4, 9.3.8)
Absorbed dose as function of conveyor speed, beam current, scan width, …(9.3.5)
Dose variability / reproducibility (9.3.5)
Process interruption/Restart for both
conveyor and electron beam (9.3.6)
Single sided and double sided all routine processing parameters

6. IQ/OQ Tests – Prerequisites
Acceptance criteria
(energy, current, scan width, speed, …)
Definition of requalification interval
Dosimetry systems, tools, …
Physical measurements
(Electrical, Time, Distance, …)
 calibration / uncertainty
Tolerance Interval
Measured data

7. Example of IQ results Electron Beam Energy (8.2) Electron Beam CTA
Dosimeter
CTA strip
2-piece
Al Wedge

8. Example of IQ results Electron Beam Energy (8.2) Density : 2.711 g/cm3
Angle : °

9. A3.14 from ISO/ASTM 51649 standard
Example of IQ results
CTA strip
Electron Beam Energy (8.2)
A3.14 from ISO/ASTM standard

10. Example of IQ results Conveyor Speed (8.2) Laser counter / Stop watch
Before and after the beam stop ?

11. Example of IQ results Conveyor Speed (8.2) Empty Tray 60 kg charge
Target Speed (m/min)
Average Measured speed
(m/min)
Difference between Measured and Target at 95 %
2,00
2,01 +/- 0,01
1,5 %
6,00
6,05 +/- 0,03
1,8 %
10,00
10,07 +/- 0,04
60 kg charge
Target Speed (m/min)
Average Measured speed
(m/min)
Difference between Measured and Target at 95 %
2,00
2,01 +/- 0,01
1,5 %
6,00
6,04 +/- 0,04
2,0 %
10,00
10,09 +/- 0,07
2,3 %

12. Example of IQ results
Scan width/uniformity (8.2)
What is the issue ?

13. Example of IQ results Scan width/uniformity (8.2)
CTA strip
Courtesy of BGS - Germany

14. Example of IQ results Scan width/uniformity (8.2)
Length (mm)
Dose (kGy)
Courtesy of BGS - Germany

15. Example of IQ results Spot size (Scan length) (8.2)
What is the issue ?
FWHM at height of 30cm
FWHM at height of 60cm
FWHM at height of 5cm
CTA strip
Courtesy of BGS - Germany

16. Example of IQ results
Product height (8.2)
What is the issue ?

17. Example of IQ results
Product height
FWT 60 2p

18. Example of IQ results
Product height

19. Example of OQ Results Dose distribution Surface (9.3.4)
Inside material (various densities) (9.3.4, 9.3.8)

20. Example of OQ Results Dose distribution
Inside material (various densities)
GEX Windose

21. Surface dose distribution
 Dsurf +/- 5% (at 3 sigma)
Courtesy of BGS - Germany

22. Dose distribution inside material
Single sided Irradiation
Density 0.07 g/cm3

23. Dose distribution inside material
Single sided Irradiation
Density 0.07 g/cm3
Depth 0 g/cm²
Density 0.07 g/cm3
Depth 3.7 g/cm²
Courtesy of BGS - Germany

24. (different densities)
Dose distribution inside adjacent material
(different densities)
Courtesy of BGS - Germany

25. Example of OQ Results
Absorbed dose as function of conveyor speed, beam current, scan width (9.3.5)
Alanine, GEX, FWT dosimeters
Alanine
FWT 60 2p
GEX Windose
DoseSurf = K I
V . Wb

26. Absorbed dose as function of conveyor speed, beam current, scan width (9.3.5)
I / (Speed*SW) in mA.min/m2
Absorbed Surface Dose in kGy
Dsurf = 10,77 * (I/(V*Wb)) + 0,04
 K = 10,77 kGy.m2/(mA.min)
Courtesy of BGS - Germany

27. Absorbed dose as function of conveyor speed, beam current, scan width (9.3.5)
Redisue in %
I / Speed in mA.min/m
RMS = 1.7 %
Courtesy of BGS - Germany

28. With routine dosimetry system !
Example of OQ Results
Dose variability / reproducibility (9.3.5)
With routine dosimetry system !
Target Dose
Irradiation 1
in kGy (CV%)
Irradiation 2
Irradiation 3
Average Dose
12 kGy
11,93 +/- 0,18 (1,5%)
11,81 +/- 0,28 (2,3%)
11,74 +/- 0,20 (1,7%)
11,83 +/- 0,22 (1,9%)
30 kGy
29,59 +/- 0,48 (1,6%)
29,80 +/- 0,61 (2,0%)
30,99 +/- 0,50 (1,6%)
30,07 +/- 0,82 (2,7%)
62 kGy
63,67 +/- 1,30 (2,0%)
62,98 +/- 0,97 (1,5%)
62,77 +/- 0,55 (0,9%)
63,14 +/- 0,98 (1,6%)

29. Example of OQ results Process interruption/Restart Conveyor (9.3.6)
CTA strip
Process interruption/Restart
Conveyor (9.3.6)

30. Process interruption/Restart
Conveyor Stop
Courtesy of BGS - Germany

31. Process interruption/Restart
Conveyor Stop
 Uniformity better than +/- 5 %
Courtesy of BGS - Germany

32. Conclusion : What is commissioning?
IQ/OQ of the irradiation plant follow :
ANSI/AAMI/ISO :2006
ANSI/AAMI/ISO :2006
ISO/ASTM 51649:2005
ASTM E +
 Knowledge of the process
Capacity of plant of delivering appropriate doses within defined acceptance criteria
Help for process uncertainty assessment

33. Commissioning is no longer what it used to be: Installation and Operational Qualification (IQ/OQ) for an Electron Beam Plant
Thank you very much !
Florent KUNTZ1, Benoît MULLIER2, Hervé MICHEL3
1 Aerial-CRT, Illkirch France
2IBA, Louvain la neuve, Belgium
3Synergy Health, Däniken, Switzerland