ISO 13485

Medical & Clean Room Injection Molding


    All-Plastics has expertise in providing cost-saving, high quality injection molding solutions to the Medical Device industry. Our expertise in medical injection molding allow us to support tight tolerance micro-sized components to complete medical devices.

    Our experts provide Project Management solutions from Concept to Operational Excellence, including full program documentation and component traceability.


    What is Medical Plastic Injection Molding?


    Medical injection molding is a plastic molding and manufacturing process involving liquefied plastic into a mold to create plastic products of various shapes and sizes. In this process, the plastic is allowed to conform to the shape of the mold and harden to produce the desired finished product.


    Material selection and method of production are always key considerations in the manufacturing of products, devices, and components for the medical industry. This is because of the strict regulations and standards that govern the industry. Plastic injection molding meets these requirements and offers a wide range of benefits for the medical industry.


    What Plastic Products Are Manufactured During the Medical Injection Molding Process?


    All-Plastics employs a state-of-the-art plastic injection molding process in order to produce high-quality medical products that meet the strict guidelines set by regulatory bodies. This ensures the safety and efficiency of all manufactured medical products and tools, which include:


    • Beakers
    • Test tubes
    • Lab and clinic housings and casings
    • Implantable components
    • Surgical blades
    • Surgical tools
    • Pacemaker parts
    • Orthopedic and dental instruments
    • Needle housing
    • Instrument handles
    • Suture delivery devices
    • Prosthetics


    Benefits of Medical Plastic Injection Molding


    All-Plastics caters to your need for durable plastic medical components that comply with strict FDA standards and regulations. 


    By employing advanced medical injection molding in our manufacturing process, we are able to supply high volumes of medical components without sacrificing quality while meeting your target specifications.


    Our medical plastic injection molding process offers the following benefits:


    • Desirable Mechanical Properties: A unique production environment enables the production of medical components bearing desirable mechanical properties, including impact resistance, which protects against wear and tear, and heat resistance, which protects material integrity during repeated sterilization.
    • Reduced Risk of Breakage: The production of components under intense pressure reinforces their durability, which increases their resistance to breakage.
    • Quality and Regulatory Compliance: All-Plastics uses high-quality, medical-grade materials and employs strict quality control measures to meet strict FDA guidelines on producing products intended for medical use.
    • Precision Manufacturing: Mass production of medical components is made possible by the high-volume, precision production capabilities of the medical injection molding process, which enables the production of large quantities of medical products without sacrificing uniformity and quality.
    • Cost-Efficient: Due to the process’s ability to process large quantities of high-quality products, the cost of production of all outputs goes down, making it a cost-efficient manufacturing option. In effect, we can pass these savings on to our customers, allowing us to offer competitive prices for our products.
    • Broad Material Selection: All-Plastics works with a wide range of medical-grade materials to obtain desired characteristics according to our client’s specifications.


    Accuracy of +/- 25 Microns


    Medical Applications & Industries

    All-Plastics works with a variety of medical industries to provide injection molding services to help create, design, and mold custom applications and parts. Some of the medical markets we serve are:

    • › Diagnostics
    • › New Therapies
    • › Orthopedic
    • › Wound Management
    • › Vascular
    • › Disposables
    • › Patient Monitoring
    • › Surgical Equipment
    • › Infection Prevention
    • And More…

    Medical & Clean Room Injection Molding Capabilities

    • Wide range of best in class medical injection molding equipment (tonnage 14 – 1,000/ shot size 0.358 – 288 oz)
    • Class 100,000 Clean Room (ISO Class 8) injection molding
    • Class 10,000 Clean Room (ISO Class 7) injection molding
    • Hardwall & Portable Clean Rooms
    • Patented in-mold labeling & assembly capabilities
    • Complete Quality Control & Inspection
    • Shot-by-shot Part Traceability
    • ISO 13485: 2016 Certified;
    • IQ/OQ/PQ Validation, Per Customer Requirements
    • Fully Automated Work Cells: servo robotics, vision systems, box loaders & more
    • Speed-to-Market
    • Class I/Class II/ Class III devices
    • Full range industry leading secondary equipment and assembly
    • Processing expertise with a wide range of materials

    Benefits & Features


    Our medical plastic injection molding and clean room molding production solutions that increase quality, security and provide cost advantages for the Medical Market are:

    • Cavity Sorting
    • Decoupled III Systematic Molding
    • Material Handling
    • Product Validation
    • Over Molding
    • Part Verification
    • Multi-shot Molding
    • Real Time Production Reporting
    • Assembly
    • Product Development
    • Insert Molding
    • Project Launch & Transfer
    • Precision Color Blending
    • Program Management