SPECIALTY COMPOUNDING AND MASTERBATCH FOR MEDICAL APPLICATIONS
Manufacturers of medical devices must follow Good Manufacturing Processes (GMP) to ensure their final products comply with various global regulatory demands. Americhem understands the critical evaluative criteria that medical device manufacturers and molders must meet when it comes to engineering materials. Our ColorRx® pre-colored medical compounds and masterbatch are specially created with precise properties and biocompatible resin technology to achieve exact processing requirements and product expectations. These can include tight color tolerances, specific pigment classifications, low friction surfaces, FDA-compliant ingredients, proven structural integrity, and more.
Looking for biocompatibility tested medical grade polymers?
Our highly experienced teams of specialty compounding experts are waiting for you! Click the button below to get in touch with an Americhem medical product coloring specialist to learn more about ColorRx®.
UNMATCHED RELIABILITY AND COMPLIANCE
ColorRx® polymers are produced in three ISO 13485 and cGMP compliant facilities in the U.S., Denmark, and China, ensuring the highest standards of quality and reliability. The formulations are locked and undergo rigorous ISO 10993 biocompatibility testing, providing peace of mind for healthcare applications. When considering your medical application, know that major medical device manufacturers around the globe trust Americhem to reach their color differentiation and color-coding goals.
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PERSONALIZED SERVICE
Working hand in hand with a member of our world-class commercial color team, we’ll start by conducting a thorough interview to determine your exact product needs. These documented answers are used by our chemists to customize an innovative ColorRx® formula in our full-service lab. Color chip samples are then sent to you for approval, along with the defined parameters, to confirm our mutual understanding of all requirements. Americhem’s commitment to personalized service ensures optimized solutions and total responsiveness for our medical plastics customers.
Manufactured in State-of-the-Art Facilities
ColorRx® is manufactured in two state-of-the-art clean compounding facilities in the U.S. and Denmark, guaranteeing the purity and quality of the polymers. This is crucial for maintaining the integrity of medical devices and ensuring patient safety.
Sustainability & the Environment
Americhem and ColorRx® is committed to sustainability, offering eco-friendly formulations that reduce environmental impact. This directly aligns with the growing demand for sustainable healthcare solutions.
Available in Compound or Masterbatch with Endless Color Options
Americhem offers ColorRx® in compound or masterbatch. We also offer ColorRx® medical grade polymers in a standard color palette, with custom colors available upon request. Our experts are here to help find the right solution!
Advanced Process Change Management
With a robust process change management system and notice of change protocols, ColorRx® ensures consistency and reliability in every batch. This minimizes risks and ensures that your medical devices meet stringent regulatory requirements.