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

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

Introduction – Relevant standard/guides ANSI/AAMI/ISO 11137-1:2006 ANSI/AAMI/ISO 11137-3:2006 ISO/ASTM 51649:2005 ASTM E2303-11 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

Description of a standard process Installation Qualification Tests 1 ENERGY/CURRENT (8.2) (8.6) (8.5) ANSI/AAMI/ISO 11137-3:2006 ISO/ASTM 51649:2005 SPOT SIZE 2 SCAN WIDTH 3 SCAN UNIFORMITY PARALLELISM* 4 * optional PRODUCT CENTERING 5 CONVEYOR SPEED 6

Operational Qualification Tests Homogeneous material (various densities) ANSI/AAMI/ISO 11137-3:2006 ISO/ASTM 51649:2005 ASTM E2303-11 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

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

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

Example of IQ results Electron Beam Energy (8.2) Density : 2.711 g/cm3 Angle : 16.0 °

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

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

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 %

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

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

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

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

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

Example of IQ results Product height FWT 60 2p

Example of IQ results Product height

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

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

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

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

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

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

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

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

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

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%)

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

Process interruption/Restart Conveyor Stop Courtesy of BGS - Germany

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

Conclusion : What is commissioning? IQ/OQ of the irradiation plant follow : ANSI/AAMI/ISO 11137-1:2006 ANSI/AAMI/ISO 11137-3:2006 ISO/ASTM 51649:2005 ASTM E2303-11 +  Knowledge of the process Capacity of plant of delivering appropriate doses within defined acceptance criteria Help for process uncertainty assessment

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