W911QY21C0065

Small Business Innovation Research Program (SBIR) Phase I

Innovative Approach to Produce Shatter Resistant Auto-Injector Formula Containers

Design, Testing and Production of Shatter Resistant Autoinjector Formula Containers

Impact cracks and checks in Type I glass cartridges arising from damage during manufacturing, handling, and transportation can be prevented by incorporating a shrinkable, high-clarity elastomeric sheath around the exterior of the cartridge. Rx Bandz proposes to explore the addition of an energy-absorbing polymer jacket to the exterior of the cartridge surface, augmenting its strength and destroying defective units in production. Rx Bandz will design, develop, and test Type I 1mL cartridges reinforced with a perfluoroalkoxy (PFA), fluorinated ethylene propylene (FEP), or silicon jacket. These materials were considered for their shrink recovery, energy absorption and ease to integrate into a medical device. Assembly of the sheath over the cartridge will take advantage of the shrink recovery of the proposed elastomers by first expanding the sheath and then allowing it to recover around the cartridge. The compression of the recovered elastomer on the foot and shoulder of the cartridge permanently secures the sleeve. During assembly of the sheath, the elimination of critical defects resulting from upstream manufacturing processes is also considered. Destroying unidentified defective cartridges by exposing them to forces defined by the shrinking sheath will prevent failure during operation. This approach not only increases ruggedness and reliability, but also benefits from the low-cost and low-risk provided by maintaining a standard Type I pharmaceutical glass as the primary container. Rx Bandz' solution does not change properties of the glass or expose the pharmaceutical to new materials, which allows for leveraging existing data to demonstrate compliance with ISO 11608-1, ISO 13926, ISO 70788, and USP 661 (protection, delamination, chemical composition, compatibility, clarity, quality, etc). This low-risk design's success in increasing ruggedness by using energy absorption to protect brittle materials against impact and vibration is well documented. Energy absorption protects the glass from cracks and scratches that would increase criticality and weaken strength. Strength property of glass is not constant, but rather defined by its surface quality arising from the defect disturbances. Eliminating and preventing these defects are essential to mitigate the risk of a cartridge fracturing during use. A protection system of this type increases the ruggedness and reliability of the cartridge during the lifetime of the auto-injector.

The goal of phase I is to establish the technical merit, feasibility, and commercial potential of proposed R&D efforts and determine the quality of performance of the small business awardee organization.

CBD202-003

C202-003-0006

20.2

Myrna Walsh