Monitoring of Leachables in Hopital Pharmacy Compounding

Diplôme Thèse Monitoring of Leachables in Hopital Pharmacy Compounding eng 2024-05-24 2025-02-18 author Bello William 749256 director Sadeghipour Farshid 28608 Section des sciences pharmaceutiques (FARMA) director Rudaz Serge 0000-0002-4180-5417 28978 Section des sciences pharmaceutiques (FARMA) 203 10.13097/archive-ouverte/unige:183395 urn:nbn:ch:unige-1833955 Sc. 5888 <p>The evaluation of Extractables and Leachables (E&L) is based on well-established industrial practices, reinforced by toxicological research. In hospital pharmacy, the lack of systematic E&L assessment, combined with the improper use of medical packaging, exposes frail and vulnerable patients to potentially toxic leachable compounds. This issue stems from a lack of awareness, financial constraints, and insufficient regulations.</p> <p>To address this challenge, it is crucial to establish guidelines, implement analytical monitoring, and develop risk assessment workflows. This thesis highlights an innovative approach using UHPLC-HRMS and the DELTA database to identify and semiquantify leachable compounds. An optimized sample preparation method, tailored to hospital pharmacy compounding matrices, has been developed to enhance detection. The results indicate that certain packaging materials reach concerning toxicological thresholds, emphasizing the urgent need for stricter monitoring of materials used in hospital pharmacy.</p> Hospital pharmacy compounding Off-label use of plastic primary packaging Container closure integrity Leachable compounds Medical device regulation Risk analysis Dewey 615 31 Section des sciences pharmaceutiques 17 false 887 Pharmacie hospitalière et clinique 8d2115cb-96ae-424b-a8b9-83a42e8ed295 Thesis Public WilliamBello_Manuscript_-_official.pdf 24082391 application/pdf CC BY-4.0 0b7544ff5d56e581dd98fce1ac44d8b19e63022ba354f32b03899d183767e607 16b4b17e-c418-4da7-b0c4-a9ad936c8659 Imprimatur Public Imprimatur_officiel_signed.pdf 541194 application/pdf 6349e31e44c530feb0221d207a92ad815a1a99e34bb1cc2e9f747c8d5d657965 d759ba57-072c-4c6e-9fbb-72eb11b26d39 Summary Public Summary_of_thesis_-_Resume_de_these.pdf 87275 application/pdf CC BY-4.0 707a6681bef90721e49172f823ab09ec8417a72881caa829b2f92703ffdf268b openAccess Faculté des sciences / Section des sciences pharmaceutiques

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Monitoring of Leachables in Hopital Pharmacy Compounding				2025	175	238

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Bello, William

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