Custom injection molding services
A contract manufacturer with expertise in injection molding and other processes develops custom products for the medical device industry. Providing components made using all-thermoplastic polymers for a range of medical device applications, the company offers injection-molded products with tight tolerances and small dimensions. It also specializes in multicomponent injection molding, insert molding, and sandwich molding applications. From the initial concept phase and prototyping through full production, the manufacturer operates cleanroom facilities that comply with ISO 14644 and maintains a certified quality management system in accordance with ISO 13485 and ISO 9001 standards.
Molded components and assemblies
Employing scientific molding, a contract manufacturer of medical device components and assemblies produces molded parts. This process-development practice involves the statistical analysis of key variables, including material temperature, flow rate, pressure, and cooling rate, to enhance the precision and reliability of thermoplastic components. Using this approach, the manufacturer can calibrate its machinery to produce a consistent set of material conditions across different molding presses, thereby producing consistent parts with the same material properties from lot to lot. Certified to ISO 13485 and ISO 9001 standards, the company specializes in micromolded and two-material components and also performs silicone molding.
Providing plastic-part design, prototyping, sheet-metal fabrication, and medical device manufacturing, a custom plastics molder and contract manufacturer specializes in large-part molding. Certified to ISO 9001:2000 and ISO 13485:2003 standards, the company operates six injection molding facilities equipped with 123 molding machines ranging in clamp force from 28 to 4000 tn and handling shot sizes from 0.6 to 800 oz. Energy-efficient electric machines are dedicated to serving the medical device market. The company also has Class 100,000 cleanroom capabilities and performs GMP Level III manufacturing. Experienced with solid injection, structural foam, gas-assist, two-shot, and overmolding operations, the company processes commodity materials, custom materials, and conductive and engineering thermoplastics, including medical resins. In addition, it can handle jobs requiring multicavity, multiple-gate, and multiple-action molding tools.
Mack Molding Co.
Full-service molding capabilities
Offering a range of molding services, a contract manufacturer has capabilities extending from product concept to production. Certified to ISO 13485 and ISO 9001 standards, the company operates a facility equipped with a Class 10,000 cleanroom and portable Class 100,000 cleanrooms in a white-space production area. It has competencies in liquid silicone molding, insert molding, two-shot and multishot molding, medical in-mold labeling, and mold building. In addition, it employs CAD and mold-flow analysis software to verify proper material selection, part design, and mold configuration and to optimize production repeatability and efficiency. Lean manufacturing principles and other streamlining techniques help to ensure efficiency and quality during production.
Reaction injection molding services
A molder of custom polyurethane parts has a core competency in reaction injection molding (RIM), a process involving low molding pressures and temperatures that is suited for low-volume applications. Temperatures in the mold may momentarily reach 250° to 350°F, while mold pressures seldom exceed 25 to 50 psi. Employing this energy-saving method, the company forms rigid polyurethane components using low-cost injection molds. It molds prototypes as well as production quantities and provides in-house mold-building and subassembly services. The manufacturer uses RIM to produce molded enclosures and housings for medical equipment, for which it can provide a proprietary design-support process known as design for quality assembly.
Contract plastics molding
Specializing in the engineering of thermoplastics and silicone, a medical device manufacturer provides plastic injection molding, double injection molding, overmolding, and insert molding services in a cleanroom environment. The company has expertise in processing common thermoplastics such as polycarbonate, nylon, and polyurethane, as well as advanced thermoplastics such as PEEK and PEI. It can also process liquid silicone rubber. Mold making, as well as injection molding of plastics and liquid silicone, are performed in a production environment certified to ISO 9001 and ISO 13485 standards and compliant with QSR and other FDA requirements. The service provider concentrates on vertically integrated contract manufacturing services comprising small preproduction runs to large-scale production runs of millions of parts.
Demonstrating thermoplastic, thermoset, insert, and two-shot molding capabilities, a company produces a variety of medical device components in a controlled environment. It specializes in medical plastic components containing additives that enable the plastic material to degrade or biodegrade quickly upon disposal after functioning like a commodity plastic during the product’s required service life. Blended into common commodity resins during the injection molding process, the agents effectively program the plastic to degrade at a controlled rate in the presence of ultraviolet light, elevated temperatures, and mechanical stress. Operating GMP-compliant and ISO 9001–certified facilities, the company molds components for disposable medical instruments, orthopedic braces and supports, wound-care supplies, specimen-collection trays, disposable filters and tubing, containers and packaging, and other medical applications.