Technical Director Bruno Carreel approached Monmouth in early 2019 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.
Bespoke ISO Class 7 (FED Std 209E Class 10,000) 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 Bruno and his 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 HEPA filters employing multi-directional air flow principles. Unidirectional air flow systems direct filtered air downward in a constant stream. Four Clean Air Modules (CAMT2000) are fixed to the ceiling and as air enters the room it is drawn through a HEPA 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 Sesome team perform manual assembly steps of a neurovascular guide (threading, welding, gluing), 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 window panes. The Cleanroom also included sliding doors and twelve LED light panels.
“We had very little space available in our offices to incorporate a clean room. The Cleanroom was required to manufacture medical devices and Monmouth Scientific’s solution was adapted to our plans to maximize available space. We managed to maximize the production spaces to make the room pleasant and bright.
Monmouth have been incredibly responsive. They managed to build and validate the room in less than 3 weeks.
Their modular solution is perfect, and we will expand if our needs change.”