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End-to-end development, manufacturing build and packaging design for an innovative deep lung breath sample collection device.
From prototype to clinical build, Sanner developed PMB-Hale(TM), a deep lung sample collection device
PulmoBioMed needed Sanner to build on the solid foundation already established by the PulmoBioMed team, by taking the designs through the stringent multi-step product development process. This included conducting a risk analysis for the device and testing the current prototype and design iterations.
Tolerance analyses were performed to predict performance and ensure reliability. The existing 3D data was checked under clear and stringent design for manufacturing principles. The design was also adapted in such a way that it is optimised for the production of the parts by injection moulding.
The early involvement of the Design Transfer teams within the Sanner Group organisation shows a clear benefit of a full-service CDMO
with agile and connected, collaborative units. To ensure performance and reliability, mould flow simulations were conducted to guide the mould design for production. These analyses help identify potential weak points early on, allowing both the components and the mould to be optimised for large-scale manufacturing. The device includes a total of 17 injection-moulded parts, along with two additional purchased components that must also be integrated into the manufacturing and assembly process.
As the last step, the team at Sanner compiled all the documentation needed to transfer the designs to manufacture. Sanner has decades of experience injection moulding and packaging development. Tooling experts are available to support at any time and their understanding of moulds and injection moulding behaviour forms the perfect basis for transferring the device to the commercial manufacturing process. The Sanner Group manufactured the PBM-Hale(TM) in an ISO Class 7 cleanroom to meet the product requirements set.
We were impressed with Sanner’s professionalism from the get go and the quality of workmanship as we saw our 3D printed prototype mature into a robust, high quality injection moulded product. The process handover from design for manufacture to scaled production was smooth and the partnership progressed productively in the context of SME needs vis-a-vis stringent quality and regulatory criteria. We look forward to establishing global supply for PBM-Hale with Sanner GmbH.
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