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Conçue pour être intégrée dans une salle blanche ISO 7, elle est réalisée conformément à la norme 21 CFR Part 11, notam- ment en suivant le protocole GAMP5, la docu- mentation descriptive (FDS, HDS et SDS) et selon les protocoles de validation et de qualification (FAT, SAT, QI et QO). Les contrôles de conformité de tous les produits à chaque étape de l’assem- blage, combinés à la traçabilité de tous les événements, garantissent une production suivie et contrôlée. Cette machine d’assemblage adap- tative et modulaire permet la production d’une grande variété de références clients et illustre parfaitement à quel point Technic Automation est un partenaire robuste pour concevoir, fabri- quer et installer tout type de machine d’assem- blage de dispositifs médicaux en salle blanche. Reliable Connectivity from Production to End Use TECHNIC AUTOMATION Company belonging to Vinci Energies, Technic Automation apply to the Pharmapack Awards with one of its latest innovation: a modular syringe assembly machine of 4 different sizes. Designed to be integrated in an ISO 7 clean room, it is carried out in compliance with the norm 21 CFR Part 11 especially following the GAMP5 protocol, the descriptive documentation (FDS, HDS and SDS) and according to valida- tion and qualification protocols (FAT, SAT, QI Robust RFID-Labels for pharmaceutical and medical applications and QO). Conformity checks of all the pro- deliver perfect performance in the various manufacturing processes and across the entire supply chain. ducts at each assembly steps combined with all events traceability guarantee a monitored What is your specific challenge? Talk to us and together we will find the optimal solution for you. and controlled production. This adaptive and modular assembly machine allows the produc- Visit us at Pharmapack 2020 tion of a wide variety of customer references Hall 7.2, Booth D46 and is a perfect illustration of how Technic Innovative labels. Smart solutions. automation is a robust partner for designing, Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG manufacturing and installing any type of medi- Bruckmannring 22 · 85764 Oberschleissheim · Germany · Phone +49 89 31584-5400 info@schreiner-medipharm.com · www.schreiner-medipharm.com cal device assembly machine in clean room. SP _e RFI- us_P r euical_Pot 0x 0_R.ind 9. 1.0 1 :5 January - 2020 / The Pharmaceutical Post 01 43 TNEVE