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Master Thesis

Mise en place d’une stratégie de validation d’un procédé de stérilisation de matériel dans le cadre de l’industrialisation d’une nouvelle ligne de répartition aseptique

Abstract : The increasing arrival of biological drugs on the market has consequences for the pharmaceutical industry. This is a challenge for production facilities and it impacts the manufacturing processes. Plants must adapt to this new activity and upgrade their production lines or create new ones. The manufacture of biotechnological products includes distinctive features due to the nature of the active pharmaceutical ingredient. A key unit operation of the manufacturing process is the filling step, which takes place under aseptic conditions. Each aspect is reviewed from the standpoint of achieving and maintaining an assurance level of sterility of the finished product. Environment, equipment and materials necessary for the production must meet this condition. The material sterilization is an essential requirement for the manufacture of these drugs. Knowledge of the product and its constraints helps to define the filling process which determines the choice of material and the sterilization process. The prerequisite for the use of a manufacturing process is its validation. Validation covers activities demonstrating the reliability and robustness of the manufacturing process. It ensures process control, minimizes risk to the patient and ensures the quality and safety of the finished product. This thesis presents the work of setting up a validation strategy for a material sterilization process for a new aseptic filling line.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03474364
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Submitted on : Friday, December 10, 2021 - 10:55:24 AM
Last modification on : Tuesday, December 14, 2021 - 3:57:00 AM

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Pharmacie_2022_Ibarra.pdf
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  • HAL Id : dumas-03474364, version 1

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Antoine Ibarra. Mise en place d’une stratégie de validation d’un procédé de stérilisation de matériel dans le cadre de l’industrialisation d’une nouvelle ligne de répartition aseptique. Sciences du Vivant [q-bio]. 2021. ⟨dumas-03474364⟩

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