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Optimization of the Production Process for a Sterilizable Accessory

Optimization of the Production Process for a Sterilizable Accessory

Customer

An innovative, well-known medical engineering company in the branch of pulmonology.

Task

Optimization of the production process for a sterilizable accessory in order to minimize waste rates in manufacturing.

Solution

In cooperation with the client, we analyzed the established production process. Our analysis revealed that the joining technology being used, because of the construction conditions, did not meet the requirements. In the second step, we carried out a technological analysis of alternative joining methods. By switching to a gluing process using a biocompatible, sterilizable glue, the waste rate for this medical device was reduced to nearly zero. At the same time, the analysis allowed us to conduct a cost optimization. The new process was defined and validated with respect to all applicable standards and regulations. Over the course of this project, the necessary documentation was prepared (e.g. a process FMEA, IQ, OQ, PQ, DMR documentation etc.).

Result

The project extended over a period of nine months. A new manufacturing process with significantly less waste was defined and validated. Solnovis now produces this component in series for the client.

Your medical engineering service provider for the areas of development, documentation, licensing and manufacturing in the region Forchheim, Erlangen, Nuremberg. Engineering and OEM-service provider for medical devices, software / hardware development and prototype construction.

Member of Medical Valley (Europäische Metropolregion Nürnberg), Forum MedTech Pharma e.V., Strategic Partnership for Sensor Technology and Development Association Economic Region Bamberg-Forchheim

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