Pilot Builds

From prototype and clinical builds to sterilization studies and beyond, Interplex Medical provides the operational flexibility and systems to support all of your product build needs. Our manufacturing systems are designed so that we can complete anything from single piece prototypes and market evaluation builds to full-scale steady state production. We also offer our facility in Cincinnati as a pilot development site in preparation for assembly to transfer to Mexico.

Class 100,000
Clean Rooms

Interplex Medical takes great pride in our facility and that is most evident in our Environmentally Controlled Rooms (ECR’s). All of our ECR’s are ISO 14644 Class 8 certified with continuous monitoring and quarterly testing. We offer a wide range of manufacturing and assembly methods including fully automated, semi-automated and manual assembly. We have extensive experience in adhesive bonding, light curing and welding of various materials. Our ECR’s allow for a controlled storage and assembly environment for the most sensitive products.

Design for Manufacture, Assembly
and Quality

Interplex Medical excels at creating products that are cost effective, stable and reliable. We accomplish this by using a number of different approaches, tools and methods. Design for Manufacture and Assembly Quality (DFMAQ) is a core fundamental service that Interplex Medical provides. Through early supplier selection and development, we begin designing for the best cost, quality and manufacturing alternative before the design becomes a product. Whether it is using tools such as Quality Functional Deployment, Boothroyd & Dewhurst or Value Analysis methods, the decisions made early in the design process have the greatest impact on cost and quality. Interplex Medical recognizes this and demands DFMAQ on every device we manufacture.

Lean Manufacturing and Six Sigma

At the heart of our manufacturing operation lies the fundamental practice of Lean Manufacturing. Through the use of tools, such as Value Stream Mapping, Spaghetti Diagrams and Total Productive Maintenance (TPM), Interplex thinks lean right from the beginning. Our use of cellular manufacturing and single piece flow assembly allows us to maximize operational efficiencies with the flexibility of immediate line changeovers. Our Six Sigma DMAIC approach to problem solving and the use of experimental designs (DOE’s) for process development ensure robust and validated processes. We take great steps to make sure that our measurement systems reliably monitor and control our processes and your products. Use of process control charts and process capability indices ensure consistent and reliable products through the elimination and control of process variation.

Contract Packaging

Interplex Medical recognizes that manufacturing does not end with the device. Packaging and labeling are very important aspects of GMP compliance. We offer a wide range of packaging options from bulk packing in trays, to single unit pouching and most everything in between. Even though we do not perform sterilization, we contract with all of the major sterilization services whether it is EtO, Gamma or E-Beam. Interplex takes great care in ensuring that your product is carefully packaged and labeled to meet all regulatory and compliance needs.

Inventory Management

Interplex Medical utilizes a fully functional ERP system to control all aspects of our purchasing, inventory management and production control. By taking advantage of supplier managed inventory, we are able to implement true Just in Time (JIT) manufacturing. Application of KanBan material replenishment allows us to have the materials we want when we need them. Interplex Medical adheres to a very stringent material and label reconciliation procedure to ensure lot tracking and traceability is maintained at all times.

RETURN TO TOP