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SCHAUMBURG, IL — AGR Medical Rubber Division, a Tekni-Plex Company, was contacted by a large pharmaceutical company to create a compound that would dramatically reduce extractables and eliminate drug contamination problems caused by commonly used sealing compounds.
AGR's laboratories, supported by in-depth research, developed an acrylonitrile butadiene compound that met the project criteria. It was developed without plasticizers. It included dry reinforcing ingredients to impart the required elastic modulus, tensile strength, and low compression set necessary for good sealing properties. Typically, compounds with dry reinforcing ingredients must utilize plasticizers which extract and interact with the drug, which causes unacceptable levels of contamination; AGR's research team found a way around that problem. The absence of plasticizers results in the low-extraction characteristics of AGR's elastometric compound. Drug contamination is therefore virtually eliminated and shelf life is increased, making the compound very desirable for use with metered dose bronchial inhalers, pre-filled syringes and other drug and pharmaceutical applications. The compound is based on an acrylonitrile butadiene elastomer, and AGR can also apply its no-plasticizer technology to other base elastomers such as bromobutyl and synthetic natural rubbers. AGR's compound is made with FDA-listed ingredients and has a FDA's drug masterfile listing that is maintained by AGR.
AGR Medical Rubber Division is one of the six companies that comprises the Tekni-Plex Healthcare Group. Tekni-Plex, Inc. is a global, diversified manufacturer of packaging, products, and materials for the healthcare, consumer, and food packaging industries. Tekni-Plex is a privately held company with 31 manufacturing facilities and approximately 3,000 employees worldwide.
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