Experiences
Development & optimization of freeze-drying cycles
Development and optimization of freeze-drying cycles (preparation cycle and product cycle) under aseptic conditions with a field-oriented approach: planning of production & supply chain trials, training of operators for the setup of probes in the aseptic area (class B gowning qualification), analysis of product temperatures, optimization of cycle parameters, and writing of protocols & reports.
Key points:
- Qualification of new freeze dryer
- Développement de cycles produits
Optimization of cooling between post-sterilization and loading on new equipment
Thermal mapping of product temperature:
- identification des positions worst case intra-étagère et inter-étagères ;
- Improvement of product temperature uniformity within the lyophilizer
- réduction du temps de refroidissement d’un facteur 3 à 4 sur des lyophilisateurs historiques, non équipés de refroidissement type double enveloppe.
Cette expérience s’inscrit dans un cadre BPF/cGMP, en lien avec la qualification, la validation, le suivi CPV et l’optimisation de procédés industriels aseptiques.
Production support & aseptic production
Hands-on experience in production (in a 5x8 cycle and during the day), in direct contact with teams, equipment, and quality constraints. My role has been to support production in the application of SOP/MOF/GMP & cGMP in an aseptic environment, while addressing process, quality, and equipment issues encountered in routine.
Key points:
- Gestion des écarts, incidents et déviations production / process / équipement
- Simple and complex investigations, root cause analysis
- Definition, monitoring, and closure of CAPA
- Quality impact assessment on batches, equipment, and processes
- Interface with management on complex investigations and action follow-up
- Cross-functional work with production, quality, maintenance, engineering, machine suppliers, and other manufacturing sites
- Writing protocols, study reports, validation and testing reports & processes
omprendre le terrain, sécuriser les décisions qualité et transformer les problèmes rencontrés en actions concrètes d’amélioration.
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