Empire Precision Plastics is a fast growing injection molder, with year-after-year additions of facility footprint, equipment, and capabilities, organically and through acquisition. Each of these expansion plans has been customer-driven. Advances in plastics technology have allowed innovation in medical device products, particularly those that include optical components. The cost savings, biocompatibility, and smaller size now possible by higher precision in plastics manufacturing are causing more and more medical device companies to turn to plastic injection molders for solutions.
Empire has worked with medical device manufacturers to produce parts and assemblies for diagnostic equipment, consumables, surgical staplers, and endoscope/laryngoscope.
The company has helped many medical device companies streamline their supply chain and improve quality, resulting in better patient safety. The need for quality control at every step has required Empire to take a measured, deliberate approach to controlling the factory environment.
Today, Empire Precision Plastics has 42,500 sq. ft. of manufacturing space, which includes:
• two micro-cleanrooms
• a fixed HEPA-filtered cleanroom
• three portable cleanrooms
Empire’s cleanroom initiative was first launched as part of an R&D project for a surgical device company. The company was developing a new product to be used in single incision laparoscopic surgery. Empire proved out the manufacturing method and the customer asked them to ramp up to full production, but the parts needed to be produced without environmental contamination on the surface. In addition to molding, assembly was needed.
Empire first added a portable cleanroom tent, and then graduated to a hard frame cleanroom with lighting, HEPA filters, and HVAC. The cleanrooms were constructed using extruded aluminum rails and Plexiglas panels. Outside the cleanroom are a gowning room and a tented molding machine. Parts enter the cleanroom on a conveyor from the injection molding machine. Empire’s automation systems include servo-driven, multi-axis robotics, streamline part handling, and secondary operations.
The stepped approach to adding controlled environments was cost effective and designed to meet changing customer requirements. The portable and micro-cleanrooms are also more economical to operate than conventional solutions and provide minimal disruption to normal precision molding workflows.
The second expansion into controlled environment molding was necessitated by a customer looking to produce medical fluid control valves. Because of direct patient contact, their product must be protected from particulates in the factory environment. By enclosing the molding system in a cleanroom, dust and surface contaminates are removed. The room covers the machine’s automated part handling while leaving access to the molding machine’s control systems. Empire worked with a local contractor that specializes in cleanrooms to make sure the room was both functional and economical.
While Empire advertises a Class 10,000 white room environment typically accepted as industry standard, their particle count is often an order of magnitude better. In general, the manufacturing environment isn’t often thought of as a clean one, but Empire’s quality control practices, environmental control, and automation have resulted in an end-to-end process with tight contaminate and dust control. In fact, for the last four years, their PPM for contamination has been zero. Since Empire created their environmental standards and implemented their first cleanroom environment, they have never had a part rejected for contamination.
The process used for validating product quality is also robust. The customer provides specifications for part acceptance, and often their own medical device validation process (DQ-IQ-OQ-PQ, or Design Qualification, Installation Qualification, Operational Qualification, Production Qualification). Empire then determines the approach and environmental controls required to ensure the desired outcome. The extensive and flexible cleanroom assets allow Empire to meet a customer’s unique needs.
Both in medical devices and the other markets Empire serves, such as military/aerospace and industrial, more and more products are including optical assemblies. To meet this need, Empire Precision acquired a polymer optics company in 2011. The new optical manufacturing capability allows Empire to produce more comprehensive surgical devices such as laparoscopic surgery tools.
Empire plans to construct a white room molding cell for medical parts as demand for opaque and optical plastic assembly increases. Like with past cleanroom designs, Empire will pay close attention to customer’s concerns to find the best solutions for their high technology applications.
Empire Precision has a 20-year legacy of partnership with its customers in solving their most challenging injection molding problems. Empire provides medical device, consumer, industrial, and military/aerospace customers with plastic molded parts and assemblies, from prototype to high volume manufacturing and assembly. Empire Precision Plastics is ISO 9001:2008 and 13485:2003 certified. www.empireprecision.com
This article appeared in the January 2014 issue of Controlled Environments.