FOCUS CFR Part 11. Un nouveau site de production répondant aux standards pharmaceutiques est en cours de réalisation près d’Annecy et devrait être finalisé d’ici la fin de l’année 2021. TECHNIC AUTOMATION : L’ASSEMBLAGE ET LE CONTRÔLE SUR MESURE TECHNIC AUTOMATION: CUSTOM-MADE ASSEMBLY Filiale d’Actemium (Vinci Energie), Technic Automation est spécialisé AND INSPECTION SOLUTIONS dans l’automatisation de procédés d’assemblage ou de contrôle, A subsidiary of Actemium (Vinci Energie), Technic Automation simples, complexes ou robotisés. Il est l’un des acteurs à avoir intégré specializes in the automation of assembly or inspection procedures, les premiers robots Staübli sur une ligne d’assemblage dans l’industriel. whether simple, complex or robotized. They are one of the players that À partir d’équipements « catalogue », cette entreprise française réalise have integrated the first Staübli robots on an assembly line at indus- des lignes d’assemblage pour les dispositifs médicaux (seringue, stylo trial level. Starting from “catalogue” equipment, this French company injecteur, matériels de perfusion ou de prélèvement sanguin, dispositif produces assembly lines for medical devices (syringes, injection pens, pour la santé animale, système de dosage, spray inhalateur...) qui infusion or blood collection materials, animal healthcare devices, répondent exactement aux besoins du client. À la différence de dosing systems, spray inhalers...) which meet customers’ needs in a precise manner. Unlike certain standard equipment, which is very little certains équipements standard, très peu évolutifs et dédiés aux séries scalable and dedicated to large volumes, Technic Automation designs de gros volumes, Technic Automation conçoit des équipements completely flexible equipment, whether mechanic or robotised. “Most totalement flexibles, mécaniques ou robotisés. « La plupart de of our linesare flexible, modular and optimized to meet customer nos lignes sont flexibles et modulaires et sont optimisées pour requirements, Florent Fumey, Commercial Development Manager says,whether the system is mechanical or robotised.” Building on répondre aux besoins du clien indique Florent Fumey, responsablet, over 30-year experience, Tehnic Automation has been operating on du développement commercial, que le système soit mécanique the pharmaceutical market for 7 years serving customers such as ou robotisé ». Fort d’une expérience de plus de 30 ans, Technic Allergan or ARaymondlife. The company also draws up all the neces- Automation intervient sur le marché pharmaceutique depuis 7 ans sary documentation (HDS/FDS/HDS) and protocols (FAT/SAT/QI/ auprès de clients tels que Allergan ou encore ARaymondlife et réalise QO). Its machinery meets the requirements of GAMP 5 and CFR Part toutes les documentations (HDS/FDS/HDS) et protocoles (FAT/SAT/ 11. A new production facility compliant with the requirements of the pharmaceutical standards is under construction near Annecy and is to QI/QO) requis. Ses machines répondent aux exigences GAMP 5 et be completed by the end of 2021. by one or two years, without requiring additional financial resources.” Design optimization upstream Medical devices & During the various phases of the project, all the Pharmaceutical aspects are analysed. “As of the design/innovation dosage stage, we ask ourselves how to use recycled or biosourced materials for circularity and/or cost-ef- fectiveness reasons, points out Hugues Brouard. The clients accept this, but most often, it is the regulation that sets the limit, especially because of biocompatibilioty reasons. We are also taking into consideration the eco-design of medical devices so A leading European player as to limit the environmental footprint and costs for in medical devices offering our clients.” both full bespoke manufacturing A trend also confirmed by Jean-Charles Blanc, Commercial Director at JBT Group, which is an and medical subcontracting! expert in the manufacturing of injection moulds and the production of plastic parts in clean rooms ISO 7 and a member of the JBT HupUp alliance: Drug & supplement administration “Optimizing the design of plastic parts is taken Respiratory conditions into consideration upstream the project as it allows Diagnostics & pre-analytics saving time and money. This is why bi-injection is often envisaged in the assembly operations and also E-health allows associating a flexible part with a rigid one. This finally leads to more complex moulds, but also to higher mould prices.” sgh-healthcaring.com June - 2020 / The Pharmaceutical Post 02 81 SSSEECCIVERD