Manufacture of fluoropolymer tubing, including synthesis and processing, reaches standard
The Biomaterials facility of Zeus, a US-headquartered international leader in material science and the manufacture of fluoropolymer tubing, including synthesis and processing, is now ISO Class 7 certified.
The 5,000ft2 facility in Orangeburg, SC is dedicated exclusively to the extrusion, analysis, and characterisation of bioabsorbable polymers and other advanced materials.
“The certification is paramount in that all processes, from conception to production, for our bioabsorbable line will take place in a very tightly controlled environment,” said Bruce Anneaux, corporate manager of research and development.
“Going beyond a standard cleanroom, our ISO Class 7 Certification spans the entire square footage of the facility.”
All aspects of bioabsorbable processing take place at the Biomaterials Facility, including raw material handling, synthesis, compounding, extrusion, inspection, and packaging. In addition to ISO Class 7 Certification, the facility is ISO 13485 certified with analytical and testing apparatus.
“For our customers, the Class 7 Certification provides added confidence that they are receiving the highest-quality products and is a testament to Zeus' continued efforts to remain at the forefront of material science,” added Josh Ridley, business development manager, Biomaterials.