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Thermoplastic Compounds for the Medical Device 
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LTL Color Compounders, Inc has developed the ColorRxª line of compounded
thermoplastics specifically to meet the demanding requirements of the
medical device and healthcare industries. LTL has supplied custom thermoplastic
compounds to the medical device and healthcare industries historically
and understands the unique requirements of these industries. The ColorRxª
product line builds on our past success and experience in this area
by providing an expanded line of compounds specifically formulated
for these markets. RX series: Approved Biocompatible IngredientsAt the present time standard ColorRxª products are based on the resin types listed below. These resin types are suitable for a wide range of medical devices and healthcare applications and can be provided in a wide range of custom matched colors. Other resin types are planned and can be added quickly to meet specific customer requirements. In addition LTL welcomes requests for customized grades designed to meet specific performance requirements. Antimicrobial Activity and Other Properties Antimicrobial activity is achieved in the ARX, AF, and A series using well-proven silver ion technology. Other functional properties are offered in the ColorRxª line as well, such as sterilizable grades and radio-opacity. Regulatory Considerations ColorRxª RX and ARX series products are intended for applications that require biocompatibility. These grades are produced using materials that have been tested for biocompatibility against either USP Class VI or ISO 10993-1 protocols. This allows the device manufacturer to proceed with the product development process with a high level of confidence that the device will pass final biocompatibility testing. ColorRxª AF grades are intended for applications that involve food contact, and are produced using FDA food contact approved materials. Quality at LTL The culture at LTL emphasizes quality in all we do. Our state of the art manufacturing equipment, first-rate laboratory, highly trained technical staff, very experienced and motivated workforce, and robust Quality Management System combine to assure that we meet our customersÕ requirements and expectations. LTL has been certified to ISO 9001 since 2000 and is in the process of obtaining certification to ISO 13485, the international standard for the design and manufacture of medical devices. ISO 13485 will take us to the next level of quality management and further assure that we meet customer expectations in the medical and healthcare markets. LTL Policy for Medical Device Applications ColorRxª compounds are not designed for nor are they promoted for or intended to be used in devices which are to be implanted in or come in contact with the human body, its tissues, or fluids for periods exceeding 30 days, or which are critical components of medical devices that support or sustain human life. LTL Color Compounders, Inc. uses USP Class VI or ISO 10993-1 compliant ingredients in the compounding of ColorRxª resins intended for applications that require biocompatibility, however, LTL has not had ColorRxª compounds tested for biocompatibility. It is solely the responsibility of the finished product or device manufacturer to determine the acceptability of ColorRxª compounds in all applications involving contact with the human body, its tissues, or fluids.
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LTL Color Compounders, Inc. 20 Progress Drive, Morrisville, PA 19067 Toll Free: 800-863-4260 Fax: 215-736-1128 |
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