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Automating the manufacture of a SteadyMed product

Case Study: SteadyMeds' Patch Pump Technology

This case study showcases the collaboration between 3P innovation and SteadyMed in automating the manufacturing process of SteadyMed's primary drug container (PDC), a crucial component of their innovative patch pump technology.

Client Background:

SteadyMed, a pharmaceutical company, developed a patch pump that offers a continuous controlled release of Trepostinil, a highly beneficial treatment for patients with Pulmonary Arterial Hypertension (PAH). Unlike traditional infusion pumps, which require frequent hospital visits, SteadyMed's patch pump provides a compact, convenient, and self-administered solution, significantly improving the quality of life for PAH patients.

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Machine Design and Features:

The machine developed by 3P innovation incorporated various cutting-edge technologies to address the challenges at hand. To maintain the necessary particulate count, a novel form of open active Restricted Access Barrier System (RABS) was introduced. This system provided ISO 5 air over the process and maintained positive pressure relative to the cleanroom, a feature not commonly found in traditional RABS systems. The machine also integrated ionised air blow and robotic manipulation of incoming injection moulded components to manage any particulates generated during the process.

Concentricity between the flexible film and the baseplate was crucial for the device's functionality as a pump. To ensure high concentricity, all processes were designed to operate on a single axis, enabling precise alignment between the cut/formed flexible film and the injection moulded primary container. Collaborative Staubli robots were utilised to pick and place pairs of primary containers and transfer vacuum-formed product trays.

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Conclusion:

Through their ingenuity and technical expertise, 3P innovation successfully tackled the complex challenges involved in automating SteadyMed's patch pump manufacturing. The development of three distinct machines, each incorporating a wide range of technologies, demonstrates the exceptional capabilities of 3P innovation's engineers in overcoming complex manufacturing obstacles.

The collaborative effort between 3P innovation and SteadyMed resulted in a reliable and efficient process, ensuring the production of high-quality patch pump devices.