812 - 838 - 0370
Medical & Healthcare Molding & Assembly
At our core, we are your dedicated partners in bringing vital medical and healthcare products to life. We combine a friendly, supportive approach with the high-tech precision your project deserves, all centered around our state-of-the-art ISO 8 Class 100,000 cleanroom.
Think of us as an extension of your team; we handle everything from molding and assembly to final packaging, so you can focus on the bigger picture. Whether you're developing surgical components, diagnostic tools, or orthopedic devices, we are committed to making your project a success with the quality and care it requires.
Medical & Healthcare Molding & Assembly
At our core, we are your dedicated partners in bringing vital medical and healthcare products to life. We combine a friendly, supportive approach with the high-tech precision your project deserves, all centered around our state-of-the-art ISO 8 Class 100,000 cleanroom.
Think of us as an extension of your team; we handle everything from molding and assembly to final packaging, so you can focus on the bigger picture. Whether you're developing surgical components, diagnostic tools, or orthopedic devices, we are committed to making your project a success with the quality and care it requires.
CLASS 8
Medical & Healthcare Molding
At our core, we are your dedicated partners in bringing vital medical and healthcare products to life. We combine a friendly, supportive approach with the high-tech precision your project deserves, all centered around our state-of-the-art ISO 8 Class 100,000 cleanroom.
Think of us as an extension of your team; we handle everything from molding and assembly to final packaging and sterilization management, so you can focus on the bigger picture. Whether you're developing surgical components, diagnostic tools, or orthopedic devices, we are committed to making your project a success with the quality and care it requires.
Our Medical & Cleanroom Manufacturing Capabilities
We provide comprehensive manufacturing solutions for the medical and healthcare industries, centered around our precision-engineered cleanroom facility. From initial molding to final fulfillment, we manage every step with an unwavering commitment to quality and contamination control.
End-to-End Services
Our services are designed to take your product from a raw component to a sterile-ready, finished device.
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Custom Injection Molding: High-precision molding for complex medical components.
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Assembly: Multi-part device assembly and sub-assembly.
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Packaging: Packaging and kitting of products to fit your needs.
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Fulfillment: Complete order fulfillment and logistics services.
Our ISO 8 Cleanroom Environment
Our entire process is built around maintaining a pristine and controlled manufacturing space to ensure the integrity of your products.
Advanced Technology & Equipment
Our cleanroom features four state-of-the-art, all-electric injection molding machines for maximum precision, repeatability, and energy efficiency.
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Robotic Automation: Each machine is equipped with robotics (including Yushin 3-axis and Universal Robots UR5 multi-axis models) for consistent, hands-off manufacturing.
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High-Temperature Resin Processing: One machine is specially configured with a high-torque motor and high-output heaters to process advanced, high-performance engineering materials.
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Continuous Quality Monitoring: We utilize on-site particle-count monitoring to ensure our cleanroom environment consistently exceeds standards.
Rigorous Contamination Control
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Advanced Air Filtration: Our system pulls, filters, and circulates conditioned air, completely exchanging the entire air volume within the cleanroom every 50 seconds.
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Secure Airlocks: All entry points, including the employee gowning room and the main loading dock, use a locking door system that prevents an interior door from opening while an exterior door is open, minimizing the introduction of outside contaminants.
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Strict Gowning Protocol: No one enters the cleanroom without covering all exposed hair and wearing a face mask, gown, gloves, and shoe covers.
Dedicated Program Management
To ensure seamless execution and clear communication, every project is assigned a dedicated Program Manager. This professional serves as your single point of contact, expertly coordinating all activities between your team, our internal departments, and any outside suppliers involved in your program.
Proven Experience & Product Applications
We have a proven track record of manufacturing a diverse range of critical medical components, including:
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Diagnostic Meters & Test Strips
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Surgical Pump Components
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Drug Delivery Components
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Cardio Monitor Assemblies
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Surgical Accessories
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Optical Scanning Products
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Orthopedic Components
Medical injection molding is a highly precise manufacturing process that creates plastic components for the healthcare industry by injecting medical-grade polymer into a custom-engineered mold. What fundamentally distinguishes this method is its strict adherence to regulatory standards, such as ISO 13485, and its execution within certified cleanrooms to ensure part sterility and patient safety. Utilizing a range of biocompatible materials that can withstand various sterilization methods, the process enables the cost-effective, scalable production of complex and consistent parts with exceptional accuracy. This makes it an essential technology for manufacturing everything from surgical instruments and drug delivery systems to diagnostic equipment housings.
Cleanroom molding is a specialized injection molding process conducted entirely within a highly controlled environment designed to minimize contamination. This environment, known as a cleanroom, maintains a certified level of cleanliness by continuously filtering air to regulate the concentration of airborne particles, microbes, and other pollutants to a specific, verified standard. The process is critical for manufacturing sensitive products, especially for the medical, pharmaceutical, and electronics industries, where even microscopic contaminants could compromise a component's quality, functionality, or safety. To maintain this sterile integrity, cleanroom molding requires strict protocols, including specialized material handling, advanced equipment, and comprehensive gowning procedures for all personnel entering the space.
The primary difference between cleanroom and white room molding lies in the level of environmental control and official certification. A cleanroom operates under strict, certified standards (like ISO 7 or 8) that guarantee a continuously monitored and controlled low level of airborne particles, achieved through advanced HEPA filtration, positive air pressure, and rigorous full-body gowning protocols. In contrast, a white room is a controlled but non-classified environment; it is cleaner than a standard factory floor and uses enhanced practices like limited access and basic gowning, but it does not adhere to the same stringent, quantifiable particle limits or require the certification of a true cleanroom. Essentially, a cleanroom offers a certified guarantee of purity for highly sensitive devices, while a white room provides an elevated level of cleanliness for products that do not require such extreme measures.
Yes! We produce both "disposable" and "durable, reusable components" for the medical and healthcare industries. Examples of products we make, which often include disposable items, are:
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Diagnostic meters and strips
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Surgical accessories
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Drug delivery components
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Surgical pump components
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