Kraton Polymers LLC announced its commercialisation of Kraton G1645, a polymer that creates new opportunities to replace PVC in medical applications.
The new product is a clear, sterilisable, and strong elastomer that offers a broad formulating window without the need for phthalate plasticisers. The polymer can be easily converted into blown and cast films and processed on other standard extrusion equipment.
The finished products exhibit a high degree of puncture resistance required in many medical applications. The product, known in the developmental form as Kraton MD6945 requires no phthalate plasticisers or other softening agents. In addition, it is available as a free flowing dense pellet and can easily be directly blended or coextruded with polyolefins.
It has a Shore A hardness of approximately 35, has a low density (0.90) which makes it an ideal replacement for PVC in medical applications. The properties of Kraton G1645 make it a natural fit for medical applications such as medical drapery, intravenous bags and drug delivery systems as well as other extruded products such as tubing for IV sets, respiratory therapy, and parenteral feeding kits.
The company said that these products have passed a battery of toxicology studies completed by an FDA recognised independent laboratory. The testing results indicate these products meet requirements under the new international ISO standards, which are much more stringent than traditional USP Class VI and it passed the ISO 10993 standard.
Kraton G1645 is approved by the FDA for use in direct food contact applications without any conditions of use or food type restrictions and compliant with the European Food Contact Directive 2002/72/EC.