Chem-Trend Launches Product Approved for Use in Medical Industry

February 26, 2014

Mono-Coat® 1973W is certified as compliant with U.S. Pharmacopeia (USP) Class VI panel of biocompatibility tests

HOWELL, Mich., Feb. 25, 2014Chem-Trend, a global leader in the development and production of mold release agents and casting lubricants, has received a “Certificate of Compliance” to the USP Class VI panel of tests by NAMSA for its Mono-Coat® 1973W. NAMSA, an independent testing laboratory, certified the release agent for use in the molding of pharmaceutical and medical components such as syringe cups and vial stoppers.

“One cannot overstate the benefit of having Chem-Trend’s Mono-Coat® 1973W successfully pass this panel of testing to the USP standard,” said George Barton, Chem-Trend senior business development director for the rubber industry. “To manufacturers in the rubber molding industry, a ‘Certificate of Compliance’ is a business imperative. This qualification will be recognized around the world as having met the gold standard for biocompatibility.”

In biological compatibility tests, 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. The panel of tests was conducted by NAMSA, a medical research organization that provides expert regulatory, laboratory, clinical and compliance services to medical device and healthcare product manufacturers.

“The medical supply community has strict standards to keep any product from contaminating items that may come into contact with biomaterial,” said Barton. “This certification illustrates that the use of Mono-Coat® 1973W would not be a source of such contamination.”

That’s particularly important for Mono-Coat® 1973W, which is a semi-permanent, water-based release agent used in the molding of rubber components used by syringe and blood vial manufacturers, as well as others. The release agent is sprayed on a mold surface to ensure easy release and proper manufacture of rubber products that eventually come in contact with biomaterial such as human blood. In addition to the benefits usually provided by Chem-Trend’s release products – reduced scrap, improved throughput, increased manufacturing efficiency – Mono-Coat® 1973W offers the additional advantage of being biocompatible.

Mono-Coat® 1973W is a durable, semi-permanent, water-based release agent that provides many benefits to the medical rubber industry:

  • Used in the molding of rubber parts used by medical components manufacturers
  • Approved as biocompatible to the USP standard
  • Suitable for use as a base coat in conjunction with a conventional top coat
  • Provides multiple releases between applications
  • Leaves little to no buildup on mold surfaces
  • Perfect for use with halobutyl rubber compounds
  • Minimal transfer from mold to molding
  • Reduces knit lines and cracks in moldings
  • Improves efficiency for medical rubber manufacturers

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. This action begins an ongoing process for Chem-Trend to have further products reviewed, and ultimately certified, to the USP standard.

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