Commercial scale manufacturing of the Tepha polymer was established in 2007 at Tepha’s state of the art manufacturing facility in Lexington, MA for sterile finished goods and component manufacturing. The established manufacturing processes include polymer formulation and blending, monofilament and multifilament suture production, and extrusion lines for fiber, film and tubing. The facility is FDA registered and ISO 13485 compliant.
A Class 100,000 Clean Room is used for assembly and packaging operations.
Tepha fibers are used in a number of textile processes including weaving, knitting and braiding. Manufacture of these products is undertaken in partnership with leading medical textile manufacturers.
Tepha also has the capability to produce TephaFLEX® multifilament fiber, polymer tubing, and thin films. The Company also has melt-blown textiles and dry spun fabrics among a number of other technologies under development.