A quality by design approach for the qualification of automating compounding device for parenteral nutrition - Université Grenoble Alpes Accéder directement au contenu
Article Dans Une Revue European Journal of Pharmaceutical Sciences Année : 2022

A quality by design approach for the qualification of automating compounding device for parenteral nutrition

Marie Piquemal
  • Fonction : Auteur
Julien Leenhardt
Luc Choisnard
Roseline Mazet
  • Fonction : Auteur
Marie-Dominique Desruet
  • Fonction : Auteur
Marjorie Durand
  • Fonction : Auteur
Pierrick Bedouch

Résumé

Automated compounding device (ACD) are increasingly used for parenteral nutrition (PN) bag production, and their acquisition must be sufficiently thought. The law requires the qualification of these ACD, but did not specify the tests to be performed. The quality by design (QbD) risk based approach allowed to define the quality target product profile in order to acquire the best ACD for each unit, and thanks a risk analysis permitted to define the critical quality attributes (CQA). These CQA will allowed to define tests performed during qualification. The ACD qualified was a 12 pump volumetric system. The CQA for PN bags consisted in sterile, precisely and accurately production with enough stability. During operational qualification volumetric accuracy test was performed, and during the performance qualification: flush volume, media fill, microbiological integrity of environment, sterility of control bag and production test were performed. At the end, all tests were conclusive (excepted for some results mostly due to analytical bias) and the ACD was considered to produce sterile bags in a control environment, precisely (relative standard deviation < 4%) and accurately (mean bias < 1% for weight and < 7% for other controls) with a sufficient stability. The QbD risk based approach allowed to acquire the best ACD for our need, and qualify relevant elements regarding the production process.

Dates et versions

hal-04557358 , version 1 (24-04-2024)

Identifiants

Citer

Quentin Perrier, Marie Piquemal, Julien Leenhardt, Luc Choisnard, Roseline Mazet, et al.. A quality by design approach for the qualification of automating compounding device for parenteral nutrition. European Journal of Pharmaceutical Sciences, 2022, 179, pp.106275. ⟨10.1016/j.ejps.2022.106275⟩. ⟨hal-04557358⟩

Collections

UGA LBFA
6 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More