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Empire Precision Plastics, Corporate Office, 500 Lee Road Suite 400 Rochester, NY 14606 (585) 454-4995 1-800-541-7135

Medical

Markets Served

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Medical device validation is a key core competency at Empire, and plays a key role in medical device manufacturing. There are 4 levels of Medical Device Validation: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification. Our staff is fully trained in these validation standards, and Empire also reaches out to many customers by supplying training both in-house (Empire) and On-site (at the customer's location). DQ-IQ-OQ-PQ is relatively new over the past 10 years, and our expertise is many times welcomed as both a refresher and brand new methodology for many customers.

Medical Device Manufacturing Expertise

Empire strives to be a world-leader in medical device injection molding, and is currently listed on the Preferred Supplier List of some of the largest medical device companies in North America. ISO 9001:2008 (1997) and ISO 13485 Medical (2010) certifications are auditted annually, and registered internationally.

Empire's cleanroom facility doubled in 2009, and is scheduled for another expansion in 2010. Cleanroom facilities require proper attire (gowning, gloves, shoe slippers, face masks), clean equipment using proper cleaning supplies (such as Isopropyl Alcohol), and procedures to insure all regulatory requirements are followed.

Over the past decade, we have been involved with many major mold moves, from a group of tools to entire companies, and we expect that experience to pay some dividends. Injection molding industry experts are predicting one of the most active periods of mold moves in the history of our industry as the economy struggles with the fallout from the economic downturn. When your molds come in, we'll get them through our Tool Room with our complete IQ Checklist, and then release them to molding. We'll tap the entire resources of our Engineering Team if need be to assign an engineer to start each mold. We'll have representatives from throughout the plant on your transition team – Customer Service, Quality, Engineering, Molding, Purchasing and Sales. We know the drill and we know how to make sure everything goes smoothly, so as to minimize disruption to your current customer needs.

Empire Precision Plastics now offers MuCell molding technology, developed by the Massachusetts Institute of Technology (MIT) and Trexel, Inc. This new technology has tremendous capabilities never before seen with other molding processes. MuCell technology is a unique microcellular foam process because it can be applied to thin-wall parts, and to materials that cannot be foamed successfully with any other methods.

Scientific Molding Principles are used throughout our plant, on all tools, in all markets. This is a big part of IQ (as seen in Medical Device Validation). Tools are put through rigorous checklists and testing to validate their mechanical and productive capabilities and robustness. Design of Experiments is also a big part of Scientific Molding, by determining which process parameters are most significant to part charactertics and variability, and optimizing the whole process mathematically.

It’s not an easy task evaluating a new injection molding service provider. Which supplier will provide your company with the best value? We invite you to check our Quick Checklist. Look at the Empire Precision Molding facts and compare! Our medical device production, injection of many different resins, and molding of many different products makes us a top competitor, and top supplier. Come see us in Rochester NY, and see first hand our capabilities.

Our quality assurance department features a large laboratory which includes a programmable CMM (Zeiss Calypso), Comparator (OGP), Vision System (Nikon OGP), and all the necessary hand tools such as Height Gages, Verniers, Micrometers, etc. All equipment is calibrated either in-house or by outside certified ISO 17025 guidelines. Fixtures are mostly built in-house (through our fine tool build facility), and some are supplied by customers. Quality is also responsible for all 100% First Article reports, Capability Studies, and basic to advanced statistical analysis. Minitab 15.0 software is utilized for advanced studies, and can be shared with customers in Minitab code, or downloaded to simple code such as Microsoft Excel.