Medical-Grade Masterbatch & Additive Solutions: Safeguarding Healthcare with Precision
In the medical healthcare sector where patient safety is paramount, our medical-grade masterbatch solutions provide a reliable foundation for medical devices and pharmaceutical packaging. Each batch is produced in a controlled cleanroom environment, fully compliant with ISO 10993 biocompatibility standards. We utilize an FDA-recognized raw material system, ensuring medical products pass pharmacopoeial tests for acetaldehyde content, density, opacity, residue on ignition, n-hexane, and heavy metals. Strict change control and batch traceability systems establish a complete, closed-loop quality management process from raw materials to finished products, delivering uncompromising safety for medical packaging.
Exceptional Performance in Demanding Medical Environments
Our medical-grade masterbatch exhibits excellent chemical resistance, withstanding exposure to common acids, alkalis, and solvents found in medical environments. FDA-certified products maintain stable performance under high-temperature processing and sterilization conditions, with enhanced UV-resistant properties. We provide uniform color dispersion solutions for medical packaging substrates such as blow-molded HDPE, PP, and PET pharmaceutical containers, as well as injection/thermoformed ABS medical device housings, ensuring consistent high-quality end-product manufacturing. Additionally, we offer liquid masterbatch solutions for silicone-based medical products.
Intelligent Traceability: Building Complete Identity Systems
Our high-contrast laser marking masterbatch enables permanent, clear UDI labeling, QR codes, and trademark markings, meeting medical device unique identification requirements. NIR-detectable medical-grade masterbatch facilitates post-use sorting and recycling, while our TAGTEC® marker technology embeds DNA-level information for anti-counterfeiting and traceability. X-ray detectable tracers ensure precise identification of plastic medical components during procedures, enhancing patient safety and procedural efficiency.
Sustainable Innovation: Driving Green Transformation in Medical Packaging
We support lightweight and mono-material packaging designs through medical-grade masterbatch solutions, combined with NIR recognition systems to improve medical packaging recyclability. Our liquid coloring solutions specifically developed for liquid silicone rubber (LSR) utilize medical-grade compatible formulations that minimize interaction risks with human tissue or medications, while reducing VOC emissions to promote the healthcare industry’s green transformation.
Comprehensive Quality Assurance
- Regulatory Compliance: Full compliance with FDA, EU MDR, and other international medical regulations
- Sterilization Compatibility: Validated for gamma, ETO, steam, and other sterilization methods
- Material Compatibility: Optimized for HDPE, PP, PET, ABS and other medical-grade polymers
- Batch-to-Batch Consistency: Stringent quality control ensuring identical performance across all production runs
- Technical Documentation: Complete regulatory support including certificates of analysis and compliance documentation
Our Commitment to Healthcare Excellence
At the intersection of life sciences and material innovation, we deliver more than just color – we provide peace of mind. From raw material selection to final product delivery, our systematic quality control system, GMP-compliant production environment, and complete product traceability records ensure that every medical device, pharmaceutical package, and diagnostic equipment receives the highest standard of safety and reliability. We stand as your trusted partner in protecting patient health through advanced material solutions.
