The new high quality sterilized and depyrogenated molded glass vials offer from SGD Pharma powered by Ompi EZ-fill® The growing parenteral market is looking for proven solutions to streamline processing, to focus effort on core acti- vities and to cut production costs. With many small size containers now developed and manufactured in collaborative partnership between pharmaceutical companies, biotech, CROs and CMOs there is now a growing need for flexible processing solutions in larger size containers (ranging from 20 - 250 ml). Demand for Ready-to-Use (RTU) systems is growing rapidly beyond traditional small packs (pre-fill syringes, cartridges & tubular vials) for key applications. The introduction of Sterinity by SGD Pharma (Paris, France), a global leader in the manufacture of pharma glass packa- ging, makes RTU premium quality molded glass vials commercially accessible for the first time. Powered by the well-es- tablished EZ Fill® system from Ompi (Padua, Italy) this new service extends the commercial and practical benefits of RTU to the widest range of biopharmaceutical and pharmaceutical applications. The launch of Sterinity, the first commercial solution for high quality RTU molded vials, offers significant potential to reduce the costs associated with aseptic filling while at the same time improving flexibility, quality and safety. By offering the very highest quality molded vials for lyophilised and liquid formulations this exciting new service extends the multiple benefits of RTU to the widest range of biopharmaceutical applications, supporting the industry in bringing products to market more quickly and efficiently. A proven process Improved inspection system Parenteral containers for injectable drug products are produced and 100% inspected in clean room environment within SGD Pharma facility. SGD Pharma high quality Type I molded vials undergo an additional inspection prior to enter Ompi EZ-fill® process. SGD Pharma’s vials are then supplied to the Ompi EZ-fill® area. Washing Containers are washed with water for injection and dried in an ISO8 class. Depyrogenation Vials are depyrogenated in a tunnel that is working accordingly to the requirements described in the standard ISO 11040 and the parameters described in the standard ISO draft for ready to fill cartridges and vials. Secondary packaging loading Containers are placed into the final packaging: either in a Nest placed into a Tub in a ISO5 class and ISO7 surrounding or in a tray handled in a ISO5 and ISO7 surrounding. Tyvek® sealing & steribag bagging Everything is sealed with a Tyvek® lid in a ISO5 class, packed in steribags and then placed into a box allowing for EtO sterilization in a ISO8 surrounding. Dedicated visual inspection is given to the cleanliness and integrity of the packaging components. Sterilization Sterilization is made through EtO and a process validated according to ISO11135. www.sgd-pharma.com Powered by Follow us: