Qualification des performances d'un robot de production de médicaments injectables en pharmacie hospitalière

Abstract : Robotics is great opportunity to help hospital pharmacists to improve security and quality and to face increasing needs of injectable preparations with inextensible human resources. This work aimed to develop a suitable qualification plan of KIRO® Oncology robot taking account robotic system complexity. To this end, Media Fill Test and microbiological sampling plan allowed to validate aseptic process and correct initial cleaning process failures. Using placebo formulations and analyzing routine production with real drugs, potential impact of excipient composition and packaging on robot performances in terms of accuracy, chemical contamination and productivity was easily highlighted, underlining necessity to qualify each drug before use. Lastly, quality control provided by robot was quantitatively and qualitatively assessed and proved that it allows to ensure the preparation of the proper drug, to the proper patient, at the proper dosage, with traceability of each step. Following modifications of factory settings and initial work procedures, KIRO® Oncology robot is nowadays appropriate for reliable and reproductible aseptic compounding of a wide range of injectable drugs while securing medication circuit both for technicians, nurses and patient. By now, challenge is to optimize productivity, but modifications of workflow and organisation are projected. In this context, question of potential automation of cytotoxic preparations, easily standardisable and allowing anticipated preparation, arises.
Document type :
Master Thesis
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Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Thursday, February 14, 2019 - 3:53:59 PM
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  • HAL Id : dumas-02019524, version 1



Thomas Deljehier. Qualification des performances d'un robot de production de médicaments injectables en pharmacie hospitalière. Sciences pharmaceutiques. 2018. ⟨dumas-02019524⟩



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