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The Client
Based on the outskirts of Paris, our client develops and manufactures medical healthcare devices.
Goals
The technical director approached us in search of a solution to guarantee a highly clean environment within which to continue research and construction of the firm’s sensor technology.
The team develop vascular access devices equipped with the proprietary sensor technology, before eventually equipping implantable devices for neurovascular, peripheral vascular and cardiovascular indications.
The Solution
Bespoke ISO Class 7 Modular Cleanroom.
To ensure optimal control of the firm’s production, it was decided that the most critical steps in the manufacturing process be internalised.
Our experienced team identified the Modular Cleanroom as the ideal solution to meet the needs of the team, allowing for close communication between design engineers and production team, vital for speeding up iterations and ensuring effective development.
The Cleanroom maintains particulate-free air through the use of filters employing multi-directional airflow principles. Unidirectional airflow systems direct filtered air downward in a constant stream. Four Clean Air Modules are fixed to the ceiling and as air enters the room it is drawn through a filter (99.997% efficient at 0.3 microns) creating 60 air changes per hour and positive pressure, guaranteeing an ISO Class 7 clean air environment.
Within the Cleanroom, the team perform manual assembly steps of a neurovascular guide (threading, welding, glueing), as well as inspection and quality control steps. The bespoke room was designed to exact requirements, including four interconnecting rooms;
- 4m x 3m
- 3m x 3m
- 2m x 4m
- 2m x 2m Changing Atrium.
The area was constructed from a free-standing aluminium framework. The room’s panel walling was constructed from aluminium composite and clear non-break polycarbonate created windowpanes. The Cleanroom also included sliding doors and twelve LED light panels.
