FineHeart, a France-based medtech innovator specialising in advanced cardiovascular devices, has partnered with Erlab to optimise contamination control in its production environment.
Erlab is a France-based design and manufacturer of air filtration systems and clean air enclosures for contamination-sensitive environments, serving pharmaceutical, biotechnology, and medical device sectors worldwide.
The production of the FLOWMAKER presents stringent cleanliness challenges
The collaboration supports the manufacture of FineHeart’s flagship product, the FLOWMAKER (trademarked), within a highly controlled ISO Class 5 cleanroom setting.
FineHeart’s breakthrough device, the FLOWMAKER, is an implantable, autonomous cardiac output management system designed to optimise cardiac performance while preserving the heart’s natural rhythm.
Project challenges
The production of the FLOWMAKER presents stringent cleanliness challenges.
The product requires precise control over air quality and, crucially, the minimisation of particulate and microbial contamination during the final stages of device cleaning.
FineHeart requires precise control over air quality
The cleanroom’s configuration added
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