INNOVATION Système de bouchage « La lyophilisation – majoritairement pour les produits oncologiques, les biotechs, et les vaccins – et son process bien spécifique demandent des bouchons parfaitement barrière à l’humidité. » d'options par la simulation, les injectables pour qui les avant même les tests de problématiques du bou- « Freeze-drying - mostly forstabilité », complète Audreychage et les demandes Pouliquen. sont différentes. Les points oncology products, biotechs, andBouchage des importants pour ces pac- kagings demandent beau- vaccines - and its very specificinjectables : technicitécoup d’attention quant aux process require stoppers thatet sécurité migrations de particules et la compatibilité contenant/ can perfectly act as a barrier toCas particulierdans cecontenu. Les industriels tra- moisture. » vaste secteur du bouchage : vaillent, entre autres, sur les Closure systems for and European markets, i.e. its very specific process technical and economic solu- injectables: technicality they must be sterilized and require stoppers that can tion both for pharma and and safety therefore “ready-to-use” perfectly act as a barrier to biotech companies. Up to the 56 (RTU), or “ready-to-be-ste- moisture. Facilitating pro- present, two machines are A special case in this broad rilized”. As a result, labora- cess implementation is the already operational and the sector of closure systems, tories gain in flexibility and objective of ARaymondlife two partners, Dara Phar- injectable formulations, for at the same time are saving and Dara Pharmaceutical maceutical Packaging and which the closure-related money. Most of them take Packaging. Last year, the ARaymondlife, aim to install problems and demands are advantage upon the repla- RayDyLyo range of all-plas- about twenty NFL filling and different. This type of pac- cement of older production tic capping solutions was a capping lines over the next kaging requires particular lines and installation of new great success upon its intro- three years. attention with regard to ones to adopt this solution. duction at CPhI in Frankfurt. particle migration and the To guarantee the sterility of They present themselves as container/content compatibi- various components, they use a real alternative to the alu- *The ISO 15378:2011 standard lity. The industrialists work, specific packaging solutions minium cap that eliminates specifies requirements for a qua- among others, on the filming developed to protect and the crimping step. These lity management system where materials (most often fluoro- transport such components. French caps adapt to different an organization needs to demons- polymer or rubber) that cover The injectables also require filling methods, especially trate its ability to provide primary or form the stoppers acting as a higher number of controls those of the NFL line. This packaging materials for medicinal a barrier. At the same time, which are necessary to latter is dedicated to the fil- products, which consistently meet the demand for sterilized ensure the smallest possible ling of vials, cartridges and customer requirements, inclu- components continues to rise. presence of particles on the syringes, directly in staked ding regulatory requirements The pharma companies are components. needle syringe presentation and International Standards asking increasingly more for In addition, freeze-drying - ready to use. With a filling applicable to primary packaging products that meet the stan- mostly for oncology products, and capping capacity of 6,000 materials. dards for the North American biotechs, and vaccines - and vials per hour, it is a leading Novembre - 2018 Doses 73 / Le Magazine du Packaging des Produits de Santé