Austere environment, durable, safe, glass equivalent auto injector container technology

SiO2 Materials Science (SiO2) is a U.S. advanced medical technology company that produces high-performance, durable, glass-equivalent primary containers that are uniquely designed to store, transport, and protect drugs, including those that require cold-chain storage. SiO2 is an SBA Defense SBIR/STTR Innovation Portal (DSIP) small business. SiO2’s primary containers are wholly manufactured in the United States and are the only available glass-equivalent alternative to traditional Type I borosilicate glass. SiO2 manufactures medical-grade polymer primary containers, including those for autoinjectors, that are coated using Plasma-Enhanced Chemical Vapor Deposition (PECVD) with a thin (20 nanometer), transparent, glass-like layer that provides a highly effective barrier to environmental gases and leachables. SiO2 also uses these manufacturing techniques to deliver glass-equivalent, ready-to-use vials, silicone oil free syringes and lubricated plungers, as well as blood collection tubes and other medical cartridges. SiO2 has developed and industrialized a novel technique for applying thin, transparent silica-based coatings on the inside surface of polymer containers, including vials, pre-filled syringes, and cartridges. This same technique is be applied to the inside surface of autoinjector containers. SiO2 applies the silica coating to the container in a unit operation where the container serves as the plasma reactor vessel. This approach ensures precise control of the coating process and simplifies the scale-up. Scale-up is achieved by replicating each unit operation. The material properties of SiO2’s pre-filled syringes for drug delivery provide unparalleled drug stability for a wide range of complex biopharmaceuticals. In addition, the containers are shatterproof and up to 15 times more dimensionally consistent than glass containers. When used in autoinjectors and drug delivery pumps, SiO2’s containers and pre-filled syringes increase the performance reliability of these drug delivery devices compared to glass containers. SiO2’s silicone oil free syringe provides the safest most robust platform for drug delivery. SiO2’s hybrid material has superior chemical, mechanical, and thermal durability and can withstand significantly more force without breakage compared to a traditional borosilicate glass syringe. The strength of the flange and hub regions of SiO2’s syringes well exceed normal use in an autoinjector device. The flange strength is 3-5 times stronger than glass syringes. Forces applied to SiO2’s container during flange failure testing are at or above 900 N, which far exceed normal use in an autoinjector.