Context
FineHeart, a French company specializing in the development of innovative medical devices, stands out for its major contributions to the cardiovascular field.
One of its flagship advances is the FLOWMAKER®, an implantable and autonomous cardiac output management system. Wirelessly powered, this mechanical circulatory assist device optimizes cardiac output while preserving the heart’s natural beats.
This patented device requires strictly controlled production conditions. To meet these requirements, FineHeart needs an ISO5-class space in its cleaning room, ensuring contamination control of devices and products handled before entering the cleanroom.
Challenges
The production of the FLOWMAKER® comes with multiple cleanliness constraints. FineHeart must control air quality and, more importantly, limit the risk of particulate and microbial contamination. The working environment must not only ensure the protection of the devices but also maintain the cleanliness class for the final washing steps.
The room configuration adds an extra challenge. The team must ensure coverage of a precise 2.04m x 2.04m surface above the workbenches, while also protecting essential equipment such as a rinse tank, a dryer, and a pass-through chamber.
The Erlab solution
To meet these specific needs, Erlab designed a custom-made ISO5-class P.Box unidirectional flow ceiling. This tailor-made solution creates a controlled environment above the cleaning room’s critical area.
The P.Box ceiling generates a vertical laminar airflow, ensuring optimal particle filtration. Designed to adapt to FineHeart’s specific cleaning room configuration, the P.Box covers exactly the 2.04m x 2.04m defined area, while also protecting critical production equipment. This custom approach was developed in close collaboration with FineHeart’s teams to ensure seamless integration into their work environment.
The P.Box solution provides FineHeart with several benefits, including:
- Optimized contamination control, by reducing airborne particles and minimizing the risk of germ transmission.
- Improved cleaning room cleanliness, maintaining ISO5 compliance with medical standards.
- Tailor-made adaptation, perfectly meeting the configuration constraints while protecting critical equipment.
Results
Thanks to the P.Box unidirectional flow ceiling, FineHeart benefits from better contamination control for its devices and incoming products. The working environment maintains the ISO5 cleanliness level, which is essential for producing a highly demanding medical device like the FLOWMAKER®. The P.Box ensures the protection of all essential equipment while guaranteeing cleanliness in the critical area of the cleaning room before entering the cleanroom.
