Americhem Healthcare is a market leader known for providing high-quality biocompatible plastics to the healthcare and medical device industry. For over three decades, Americhem has supported medical OEMs with custom medical-grade plastic compounds used across a wide spectrum of applications with formulations that meet regulatory certification compliancy and specific product goals. Learn why manufacturers worldwide trust Americhem to develop biocompatible polymer formulations that enhance caregiving.
OUR BIOCOMPATIBLE PLASTICS ARE YOUR PRESCRIPTION FOR MEDICAL DEVICE SAFETY AND EFFICACY.
Today’s medical device designers and manufacturers are challenged to hit a multitude of moving targets influenced by market demand, regulatory requirements, consumer perception, cost constraints and supply chain issues. Americhem Healthcare collaborates with our medical OEM customers to develop innovative medical-grade plastic solutions that maximize opportunities for success. We understand that advances and risks associated with patient care often go hand-in-hand with the production of instruments, devices and equipment used to facilitate medical diagnoses and treatments. Our ability to source an extensive range of biocompatible plastics and customize them according to stringent industry manufacturing standards – including ISO 10993-5 – leads to improved safety, efficacy and performance.
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DEDICATED HEALTHCARE DIVISION FOCUSED ON YOUR SUCCESS
The tremendous growth in the healthcare and medical device segment prompted Americhem to establish Americhem Healthcare, a business division launched in 2022 with the sole purpose of ensuring our medical OEM customers’ success. By combining our 30 years of experience engineering plastic for medical applications with our technical capabilities and vast resources, we are uniquely positioned to develop, produce and test new and innovative biocompatible compounds. Beyond world-class manufacturing and industry-leading standards, Americhem Healthcare’s advantages include:
- Global expertise in material selection of biocompatible plastic for medical applications
- Medical-focused engineering, production, quality and sales teams
- Market-specific research and development
- Medical device product development support
- In-house biocompatibility testing and process simulations
- ISO, FDA and global regulatory compliance support
- Locked formulations
- Rapid development
- Small and large batch production
- Lot-to-lot consistency
- Competitive lead times
- ISO 9001, ISO 10993 and ISO 13485-certified manufacturing plants
- The largest clean compounding facility in the world, located in Morrisville, Pennsylvania
WHAT IS MEDICAL-GRADE PLASTIC?
Medical-grade plastics refer to plastics specifically designed to manufacture medical devices and products. The use of biocompatible plastics in the medical field is aimed at promoting healing and recovery without causing adverse effects such as injuries, allergic reactions or toxic reactions.
For plastic to be considered medical-grade, its biocompatibility with living human cells, tissues and organs must be verified through rigorous testing. Testing a material’s biocompatibility varies depending on the type of device and whether it will come in no contact, short contact or prolonged contact with the human body.
The U.S. Food & Drug Administration (FDA) highly regulates medical devices to ensure their safety and effectiveness. Before a company can legally sell a medical device in the U.S., the device must gain FDA approval by meeting stringent design, material, process and packaging regulations. The FDA recognizes ISO 10993 and USP Class VI as respected consensus standards and test methods used to evaluate the biocompatibility of medical devices to manage biological risk.
How does Americhem Healthcare help its customers achieve ISO 10993-5 compliance?
Americhem Healthcare follows the guidelines and requirements of ISO 10993 as the basis for selecting the most appropriate medical-grade plastic for a customer’s unique application, carefully considering the end product’s expected duration of contact with biological tissues. Our material scientists augment those resins with product additives to achieve specific desired properties. Americhem is highly experienced with sourcing and processing biocompatible plastics that comply with the ISO 10993-5 standard. We perform a variety of tests, including ISO 10993-5 in vitro cytotoxicity tests, on final compounds to verify our materials’ biocompatibility with the human body. Our regulatory and material specialists work closely with our customers, providing all required documentation to prove the finished materials used to manufacture their products are ISO-certified compounds.
Can Americhem Healthcare help global customers achieve different types of regulatory compliance?
Absolutely! Our specialists have in-depth knowledge of healthcare and medical device certification standards around the globe. They can provide advice, guidance and documentation to ensure you receive medical approval in your particular market and country. We routinely develop custom plastic for healthcare devices that adheres to FDA, ASTM, ISO, MEDDEV, CMDR and ARGMD standards, among others.
What types of polymers are suitable as medical-grade plastics?
There are many types of plastics with suitable inherent properties and medical grades that can be used in healthcare and medical device applications. Americhem can customize the following medical-grade polymers with the exact features and performance requirements required for your application:
- Polyethylene (PE)
- Polypropylene (PP)
- Polyvinyl chloride (PVC)
- Polyurethane (PU)
- Polyether ether ketone (PEEK)
- Polyethylene Terephthalate (PET)
- Polyamide (PA)
- Polycarbonate (PC)
- Polyetherimide (PEI)
- Polystyrene (PS)
- Polyethersulfone (PES)
- Polymethyl methacrylate (PMMA)
- Polysulfone (PS)
- Acrylonitrile butadiene styrene (ABS)
What are some of the advantages of medical-grade plastics?
Many healthcare and medical device products come in direct contact with the human body, inside and out. Plastic or other materials that are not designed to be biocompatible can pose a great risk to patients and have devastating consequences. Biocompatible plastics are often specified over metal and other materials because they have inherent properties that make them more suitable for the manufacturing and use of medical products.
- Greater Safety – Medical-grade plastic for medical devices and healthcare undergoes stringent testing such as ISO 10993-5 cytotoxicity testing which employs cell culture techniques to determine whether the materials and their extracts cause cell damage, inhibition or death.
- Infection Resistant – Some medical-grade plastics contain infection-resistant properties that can be enhanced with antimicrobial additives to resist the growth of bacteria on surfaces.
- Durable, Chemical Resistant and Heat Resistant – Inherent properties like durability, chemical resistance and heat resistance can be optimized with different combinations of high-grade additives.
- Versatile – Medical-grade plastics are highly moldable, allowing them to be manufactured into different shapes. From disposable medical products to implantable devices, biocompatible plastic has become the material of choice for a broad range of applications.
- Cost-effective – Medical-grade plastics have a generally low material cost. They are designed to endure over time and will not corrode like metal or shatter like glass. Their ability to withstand repeated sterilizations enables operational savings.
- Recyclable – Certain medical-grade plastics can be remelted and reused during the manufacturing process to eliminate waste, and many are recyclable after the product’s end of life.
IMPROVED OUTCOMES THROUGH UNBIASED SELECTION OF MATERIALS
When it comes to engineering medical-grade compounds, Americhem Healthcare’s unbiased approach to material selection means we will work with virtually any biocompatible resin to develop a solution that’s right for you. We source, process and deliver the best materials to ensure the safety and efficacy of your healthcare or medical device product.
HAVE A CUSTOM MEDICAL-GRADE PLASTIC NEED? AMERICHEM CAN DEVELOP A UNIQUE FORMULA AND LOCK IT DOWN
Americhem’s tailored approach creates unique advantages for medical device OEMs with definitive product goals. We design all of our medical-grade compounds to our customers’ exacting specifications, creating custom materials for medical devices that meet the highest demands for quality, performance and value. With our extensive compounding expertise, we can enhance any medical-grade plastic with product additives and reinforcements that consistently and positively impact the plastic’s physical, chemical and mechanical properties.
Whether it’s high purity, high clarity, low friction, UV resistance, flame resistance, chemical resistance, impact resistance, temperature resilience, flexibility, antimicrobial protection, antistatic protection, electrical stability, high tensile strength or some other critical requirement, you can depend on Americhem’s material experts to create a custom formulation that can be locked to preserve the integrity of repetitive manufacturing.
UNLEASH THE IMPACT OF COLOR IN BIOCOMPATIBLE PLASTICS
Color plays a highly functional role in today’s medical devices, allowing manufacturers to emphasize key interaction points, aid with color coding, differentiate device elements, affect emotions and build brand identity.
As experts in color technology, Americhem offers a complete line of ColorRx® pre-colored compounds tested to meet the latest FDA biocompatibility standards. Our chemists will work with you to customize an innovative ColorRX® formula that matches your exact needs and delivers proven, long-lasting color.
BIOCOMPATIBLE PLASTIC COMPOUNDS FOR DIVERSE APPLICATIONS
Americhem Healthcare partners with a wide range of medical OEMs, developing innovative biocompatible plastic solutions for implant devices, surface devices, externally communicating devices and surgical tools. Explore how we create custom medical-grade compounds used in medical device housings and enclosures, labware and diagnostics equipment, respiratory and oxygen delivery products and surgical instruments.
MEDICAL DEVICE HOUSING & ENCLOSURES
From dimensional stability to antistatic and electrical interference, we offer a wide range of engineered compounds that meet biocompatibility standards for life-changing products like pacemakers, cochlear implants, bone screws, sutures, stents and controlled drug delivery systems.
LABWARE & DIAGNOSTICS
With a full range of ISO 10993-5 compliant biocompatible plastics, pigments and additives, Americhem can meet the unique requirements of advanced products related to hematology, histology, pathology, cytology, microbiology, blood bank and other diagnostic services offered by today’s clinical laboratories.
RESPIRATORY & OXYGEN DELIVERY
Americhem aids in the design and production of life-saving oxygen delivery systems, providing specially engineered biocompatible plastics for products like nasal cannulas, medical tubing and contoured face masks that maintain adequate oxygenation and reduce skin irritation and tissue pressure with a soft-touch feel.
Americhem’s biocompatible plastics for surgical instruments offer heat resistance, chemical resistance, slip resistance, antimicrobial protection, radiopacity, sterilization capability and more. Their unique attributes make them ideal for blood pumps, robotic components, forceps, retractors, needle holders, curettes, and trays, to name a few.
Don’t see your particular market category here? Chances are you can leverage our engineered compounding experience, proprietary product lines and product development support to meet your application needs.
PURCHASE YOUR MEDICAL-GRADE PLASTICS FROM AMERICHEM
Americhem Healthcare has the experience, technical capabilities and manufacturing capacity you want in your supplier of medical-grade compounds. We’ll collaborate with you to consistently meet the ever-increasing demands of the healthcare and medical device industry. Contact us today to take advantage of everything that Americhem has to offer.