A ninety-year-old moulding company based in the UK has expanded into medical products after building a cleanroom.
Amies Innovation installed an ISO Class 7 Modular Cleanroom in 2013, to manufacture injection moulded components for use in non-invasive detection, measurement and monitoring tests. Typical applications include parts and assemblies for point of care testing (POCT), screening for MRSA, drug abuse and monitoring blood coagulation for anticoagulant users.
IMI Norgren, an engineering company based in Birmingham, contacted Amies for a new project in 2013, with the pre-requisite that Amies Innovation achieve the accreditation ISO 13485 and it use a cleanroom.
At the time Amies agreed it would install a cleanroom at its plant in Chesterfield, Derbyshire. Following a recommendation from its moulding machinery supplier, Connect 2 Cleanrooms were chosen to design, make and install a modular hardwall panel system with a softwall entrance, covering 25.5m².
The cleanroom, which achieves 96 air changes per hour, includes the ECO 1 System allowing the operators to constantly monitor the cleanroom by recording the temperature, humidity, filter pressure and particle counts.
The modular cleanroom option was the ideal choice for Amies Innovation, due to IMI Norgren being a new project and their first requirement for cleanroom operations, as it allows them to expand or relocate their cleanroom at a later date based on capacity requirements.
Bob Ball, Managing Director at Amies Innovation, said: “The installation of our cleanroom has not only increased our sales but has also improved our credibility in the medical sector. It has been fully operational for three years and we are now looking to expand the room to house additional machinery due to the manufacturing demand.”
Connect 2 Cleanrooms lab inspection
