Release agent approved for use in the medical rubber industry
Chem-Trend Mono-Coat® 1973W meets strictest requirements on biocompatibility, Maisach
Chem-Trend has received a "Certificate of Compliance" to the USP Class VI panel of tests for its Mono-Coat® 1973W. The semi-permanent, water based release agent is used in the molding of pharmaceutical and medical rubber components that may come into contact with biological material such as human blood. This includes syringe cups and vial stoppers, among others.
"The medical supply community has strict standards to keep, especially with any products that may come into contact with biological material," said George Barton, Chem-Trend senior business development director for the rubber industry. "This certification is recognized around the world as the gold standard for biocompatibility. It underscores Chem-Trend’s commitment to the development of tailored solutions for highly specialised applications."
In biological compatibility tests conducted by the independend medical research organisation NAMSA, Mono-Coat® 1973W was found to meet the requirements of a USP Class VI. The USP sets the standards for prescription and over-the-counter medicines and other health care products sold in the United States, as well as food ingredients and dietary supplements.
Mono-Coat® 1973W ensures easy release of the finish rubber products from the mold and the manufacture of clean parts with fewer knit lines and cracks in moldings. The product also helps reduce scrap and increase efficiency in the manufacture of medical rubber components. The new release agent is especially well suited for use with halobutyl rubber compounds.
Mono-Coat® 1973W is the first of Chem-Trend's suite of products to be certified to the USP Class VI standard for use in the medical rubber market. Additional Chem-Trend products are planned for review and evaluation for certification.