TECHNOLOGY SPONSOR: Glass
The Mission of the Company
SGD Pharma is constantly working to improve the level of service for customers for the development of new products or the regulatory, laboratory, quality, and logistics support they offer. In 2019, SGD Pharma developed the first application for the identification of noncompliances in molded glass bottles for the pharmaceutical industry. Resulting from the development efforts of the Quality and Marketing Departments, this new digital tool makes it possible to identify noncompliances that may be discovered during a control over the reception of goods or from the primary packaging manufacturing process. The company’s goal — beyond improving safety for the end-user — is for their quality standards to be recognized as benchmarks for the pharmaceutical molded glass industry. The application also fits within the growing zero-tolerance trend, which includes cosmetic quality, and reassures hospital staff about the delivery of product to patients.
The growing parenteral market is lacking proven solutions to streamline processing. There is a focus on value-added/core activities while cutting production costs, particularly as the industry changes. With many products now developed and manufactured by collaborative partnerships between pharmaceutical companies, biotech start-ups, CROs, and CMOs, there is a growing need for flexible processing solutions that facilitate safe and reproducible technology transfer. SGD Pharma’s quality level for type I and type II molded glass is globally recognized as the best in class. More than in any other pharmaceutical market, parenteral delivery means that the packaging is not “subject to debate” — the customers’ exigency level is constantly increasing, and SGD Pharma is focused on achieving zero tolerance. That is also happening within the context of an increasingly concentrated pharmaceutical industry whose number of players has decreased, while the companies that remain have become stronger. It is a more difficult market; therefore, SGD Pharma is constantly improving and expanding their service offering.
Ready-to-use (RTU) is a cost-effective, safe, and efficient approach for aseptic filling. It is a critical activity for many organizations with molded vials essential for many applications, though often not a core service offering. In early 2019, SGD Pharma unveiled the Sterinity platform, a new solution offering to customers sterilized and depyrogenated type I molded glass vials ready to be filled. With this platform, developed in partnership with Stevanato’s Ompi EZ-fill®, SGD Pharma became the first glass manufacturer to be marketing RTU molded glass. Until now, this premium service has been offered for two products in the EasyLyo parenteral range: 20 mL and 25 mL. Initially developed to withstand the extreme pressure and temperature conditions required during freeze-drying cycles, the EasyLyo vials combine the mechanical and chemical strength of molded glass with the more lightweight and cosmetic look of drawn glass for a superior quality product. This product is currently being developed for both liquid and freeze-dried forms. SGD Pharma recently announced an extension of the Sterinity platform along with the validation of 50 mL ISO and EasyLyo vials. Molded glass deserves its place in the biotech sector or new product developments, especially for small containers. It is up to SGD Pharma to demonstrate that it can be used as innovatively as drawn glass.