Skip to Main content Skip to Navigation
Master Thesis

Maîtrise statistique des procédés (MSP) : application à la fabrication semi-automatisée en lots de préparations injectables stériles à l'Hôpital

Abstract : Statistical process control is a defect prevention method currently used in industrial production that makes the production process more reliable and stable over time by maintaining the required level of quality. A process capability index is a measure relating the actual performance of a process to its specified performance. The purpose of this study is to apply the SPC to the production of sterile injectable preparations in our centralized reconstitution units. This study was carried out with 3 peristaltic pumps from different suppliers: VERDER® (Vantage) used for the batch production of Aciclovir, BAXA® (Repeater) used for the preparation of the solvent bags necessary for the dilution of cytotoxic drugs, and the pump of the parenteral nutrition production automaton (EM2400). The masses obtained or their deviations from the target constitute the characteristic to monitor. The implementation of a control chart makes it possible to monitor and thus detect any evidence of a significant change in the variability of the process. An intervention of trained hospital pharmacy technicians on the adjustment of the pump is necessary to avoid the occurrence of non-compliance to ensure an optimal use of human’s resources. Unnecessary production costs can be avoided too (no-quality costs).
Document type :
Master Thesis
Complete list of metadatas

Cited literature [45 references]  Display  Hide  Download

https://dumas.ccsd.cnrs.fr/dumas-02384217
Contributor : Frédérique Gambade <>
Submitted on : Thursday, November 28, 2019 - 11:36:28 AM
Last modification on : Tuesday, December 17, 2019 - 1:55:26 AM
Long-term archiving on: : Saturday, February 29, 2020 - 2:38:31 PM

File

Pharmacie_2018_Estrade.pdf
Files produced by the author(s)

Identifiers

  • HAL Id : dumas-02384217, version 1

Collections

Citation

Lucie Estrade. Maîtrise statistique des procédés (MSP) : application à la fabrication semi-automatisée en lots de préparations injectables stériles à l'Hôpital. Sciences du Vivant [q-bio]. 2018. ⟨dumas-02384217⟩

Share

Metrics

Record views

43

Files downloads

3280