RadSter-4: Process control

Tuesday November 08, 2022 from 15:30 to 17:00

Room: Moon

RadSter-4.4 Monte Carlo Simulation benefits to healthcare product manufacturers in radiation processing

Samuel Dorey, France

Principal Scientist | Materials & Irradiation
Product Development


Monte Carlo Simulation benefits to healthcare product manufacturers in radiation processing

Samuel DOREY1, Ludovic EYCHENNE2, Florent KUNTZ4, Cédric DOSSAT2, Nathalie CHATRY2, Damien PRIEELS3.

1Sartorius Stedim FMT SAS, AUBAGNE, France, Metropolitan; 2TRAD Tests & Radiations, LABEGE, France, Metropolitan; 3IBA, LOUVAIN-LA-NEUVE, Belgium; 4AERIAL, Illkirch-Graffenstaden , France, Metropolitan

This study as the objective to evaluate the benefits of Monte Carlo simulation in order to decrease the total cost and fasten the time to market of products for Healthcare Product Manufacturers in radiation processing. Monte Carlo simulation main purpose is to calculate dose distribution with high precision. It is a method used to simulate stochastically the interactions between radiations and matter. The calculation can be a key parameter for the radiation processing, both during the product development (PD) phases and during the performance qualification (PQ) step. In this context, a collaboration between the companies Sartorius, TRAD, Aerial and IBA are studying the use of Monte Carlo simulations as solution to facilitate the dosimetry process during PD and PQ phases. This in-progress study is using the RayXpert® Monte Carlo software, the Feerix® irradiation facility and Sartorius biopharmaceutical products. The first step is to make a comparison between Monte Carlo simulation and dose mapping, in order to estimate the possibility for Monte Carlo simulation to reach comparable results with dosimetry. This step includes modelling of the products and the IBA X-ray source and the dose mapping at Feerix®. The second step will be to make an impact study of the packaging on the DUR and to study the design variables for a potential optimization of packaging and product. Improvements and benefits for the manufacturers will be monitored and analysed in terms of time, resource saving and customer experience, and also in terms of improvements regarding the dose uniformity for complex products and to prevent overdosing of sensitive product parts.

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