Jun 18 2004
Ticona, the technical polymers business of Celanese AG, has introduced the Riteflex® MT9000 series of copolyester thermoplastic elastomers (TPE) certified for use in drug delivery systems, medical devices, pharmaceutical and other healthcare applications, as well as in repeat-use, food-contact applications.
Riteflex® TPE MT9000 grades comply with U.S. Pharmacopeia Class VI and the U.S. Food and Drug Administration (FDA). FDA Drug and Device Master Files have been established. These grades contain no plasticisers or animal ingredients.
The series encompasses seven grades – Riteflex® TPE MT9635, MT9640, MT9647, MT9655, MT9663, MT9672 and MT9677 – that are excellent candidates for use in such applications as medical tubing, stoppers, transdermal patches and intravenous bags. They can be compounded in various FDA-compliant colours.
These TPEs offer a wide range of properties. Riteflex® TPE MT9635 has a Shore D hardness of 35, a flexural modulus of 8,800 PSI and a melt temperature of 163°C. Riteflex® TPE MT9672 has a Shore D hardness of 72, a flexural modulus of 100,000 PSI and a melt temperature of 210°C. They also can be sterilized by all common methods from autoclaving to gamma radiation.
The Riteflex® TPE MT9000 series is part of Ticona's MT medical technology line, which holds resin formulation steady for extended times so devices and packaging will not need to be requalified due to a change in material. Ticona MT grades also undergo independent testing for biocompatibililty with skin, blood and tissue, e.g., USP 23 Class VI.
Riteflex® elastomers have the softness, flexibility and resilience of rubber, yet are processed like thermoplastics by conventional molding and extrusion processes. They combine toughness and tear and flex fatigue resistance with good performance from -40° to 121°C. They also resist common solvents, oils, greases and dilute acids and bases. They are typically used in hoses, tubing, seals, gaskets, belts, pump diaphragms, wire coatings, films, sheets, nonwovens and monofilaments, among other applications.
For more information on pharmaceuticals, click here.