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    Medical

    R&D, Innovation and Speed-to-Market are Critical

    We Understand Your Needs
    HARBEC is an ISO 13485 certified, high-value partner to the Medical market. It is one of the fastest growing market segments we serve. This growth is attributed to the breadth of services we provide and the investments we continue to make in new processes, technologies, equipment, and people. This will positively impact all of our customers by expanding our commitment to company-wide improvement and quality.

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    Our Values and Commitment

    • Quality
    • Performance
    • Speed
    • Value

    Our Experience

    • Spinal Implants
    • Brain Surgery Technology
    • Surgical Robots
    • MRI and Imaging Components
    • IV Components
    • Vials & Barrels
    • Specimen Collection and Analysis
    • Medication Disbursement
    • Blood Pressure Cuffs and Hose Assembly
    • Robotic Surgical Arm
    • Reagent Closures
    • Dialysis Components
    • Surgical Headlamps
    • Scientific and Medical Testing

    An infographic comparing lateral flow assay cassette molds

    Our Services

    • ISO Class 8 (FED 100,000) Cleanroom
    • 3-D printed and machined prototype development through finished product manufacturing
    • Multicavitational molding
    • Insert manufacturing and over-molding
    • Design for manufacturability and concept validation
    • Supply chain management
    • Testing and validation—DQ, IQ, OQ, PQ
    • Specialized deburring (including micro)
    • Extensive quality staff and facility
    • Environmental control and enhanced water system ensure better results
    • Specialized part cleaning
    • Secondary services (gate trimming, CNC-machining (e.g., drilling, reaming, surfacing), annealing, and water treating)
    • Assembly (manual assembly, ultra-sonic and heat welding, heat staking, bonding, taping, labeling)
    • Decorating (hot stamping and pad-printing)
    • Logistics support (packaging, kitting, inventory management, distribution and fulfillment)

    Please click here to download a .pdf of our brochure.

    Cleanroom

    HARBEC proudly offers certified ISO class 8 cleanroom capability. Representing our commitment to provide customers with high quality tightly toleranced and sustainable manufacturing solutions, the HARBEC cleanroom offers the capability to test molds, develop prototypes, and produce parts in a controlled environment.

    The HARBEC cleanroom minimizes microbes and bacteria by filtering air through a HEPA filter, which pressurizes the room and removes 99.9% of all particles—an extremely important factor in applications for which cleanliness is integral.

    Our cleanroom capability is flexible enough to accommodate a diverse range of customer requirements. The HARBEC cleanroom is a modular device that can be customized to fit any application and built on to adapt to any project. The cleanroom goes over the molding machine, encompassing the molding area, making it as easy to use and cost efficient as it is effective. Its adaptability to fit molding machine means the possibilities are endless.

    Feel free to download our Cleanroom Molding PDF.

    Specifications of the cleanroom include:

    • ISO Class 8 (FED 100,000) Clean Room Molding (certificate)
    • Laminar flow clean room
    • Daily particle monitoring
    • Optimized for production, & prototype, clean room molding
    • 55-400 ton electric injection molding machine options with a 1.95-38oz. shot size depending on the application
    • Cleanroom secondary operations include labeling and packaging
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    The Aviation Industry is highly regulated with demands and controls that ensure the safety and reliability of equipment and materials. Our aviation, space and defense customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our processes are monitored to improve efficiency, ensure product safety and reliability while continually improving.

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    The Medical Industry is highly regulated with demands and controls that ensure regulatory requirements and customer expectations are met. Our medical device customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our ISO 13485 management system adopts a risk management approach which, while having these controls in place, eliminates hazardous situations throughout the product realization process.

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    HARBEC is a registered ITAR company. International Traffic in Arms Regulations (ITAR) is a set of United States Government regulations on the export and import of defense related articles and services. Our Defense and Military customers can have complete confidence that HARBEC has an established and implemented ITAR compliance program and adhere to the strict guidelines set forth by ITAR and EAR statutes.

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