In January 2015 we were commissioned by a Cape Town Medical Research - Bio Technology client to design and manufacture a dedicated heart valve manufacture booth.
After preliminary meetings with the client the design was finalised. There would be 2 chambers that had to be temperature controlled with recirculating Hepa filtered sterile air.
The sterile air needed to travel Uni-directionally over the manufacturing process.
The manufacturing process emits Volatile Organic Compounds, so we included activated carbon pellet modules in the return airstream to dry scrub the air and protect the operator and environment from the VOC’s.
Fans are Variable Speed Drive (VSD) controlled and filter pressure is monitored by means of Magnehelic gauges. Before hand over we carried out a full validation on the Hepa filters and fans in the unit.
The Hepa filters were tested to prove compliance with ISO 14644-3 test standards; and Uni-directional air flow velocities were measured and adjusted by means of the Variable Speed Drives.
In June 2015 the heart valve booth was brought into production and the first prototype heart valves were produced. This booth is the first of its kind in South Africa, making it possible to automate the entire manufacturing process.
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