Healthcare
Materials designed for healthcare applications
Since the 1960s, we have worked closely with our customers, often custom-formulating a material to optimize performance and consistency. To help navigate ever-changing regulatory requirements, we provide experienced regulatory advice from product conception up through commercialization and for years after. Put our experience to work for you!
The brand names ALPHAMED, EVOPRENE, MEXIFLEX, VINASTAB, and VYTHENE are trademarks of Alphagary/Mexichem.
ALPHAMED
NFPA 262, UL 910 plenum
Polymers
Alphagary has designed and manufactured flexible and rigid ALPHAMED PVC compounds for healthcare device manufacturers since the 1960s. Based on customer requirements, the VYTHENE TPU-PVC series was introduced, targeted towards applications needing improved resiliency. In the mid-1980s, we introduced SUPERKLEEN, a series of PVC compounds formulated with bio-based plasticizers.
In the 1990s, Alphagary introduced EVOPRENE TPE compounds to the US marketplace. In 2021, we carved out an EVOPRENE R series dedicated strictly to medical, pharma, food contact, toy and other related applications.
Compounds are formulated with ingredients sanctioned for indirect food contact (US FDA 21CFR, EU 10/2011, 1935/2004).
TPE compounds
EVOPRENE R-99
Flexible
Extrusion and Molding
Additives
We know how important it is for additives to seamlessly integrate and deliver dependable performance. That's why we're proud to offer stabilizers and plasticizers produced with astonishing accuracy and formulated to work consistently.
For materials formulated with reduced carbon footprint, please speak with your Alphagary representative.
Typical Applications
We’ve designed a robust material portfolio, giving multiple polymer options (PVC, TPE, TPU) to engineers as you build healthcare devices. Compounds are designed to optimize performance and are manufactured to provide the consistency that is so critical for a wide variety of healthcare applications.
Put our experience to work.
Consistency with Every Blend
We understand how important it is for materials to perform consistently and reliably. That’s why we have adopted fixed practices that govern formulation integrity, process control and data acquisition. Customers trust us for this assurance so they can focus on creating dependable devices that are so critical to our health and wellbeing.
Formulated to be Sterilized
We’ve carefully formulated compounds to withstand typical sterilization procedures – including EtO, autoclave, gamma or e-Beam – without discoloring. Please let our technical sales team know which method(s) is important and we’ll steer you toward the most appropriate material.
Class VI Biocompatibility
To streamline risk evaluation and device approval process, we provide test results conducted on our compounds to USP Class VI Biocompatibility standards. Some materials have been tested to Cytotoxicity standards and others have received ISO 10993 evaluation.
Regulatory Expertise
We have full-time regulatory expertise to help navigate everchanging regulations. And we’re transparent with reporting information. In our Safety Data Sheets, made for each product, we report Substances of Very High Concern, phthalate content, and REACH, RoHS, and Prop 65 information along with the necessary safety precautions typically found on a safety data sheets. Our customers find this information very helpful as they answer regulations and apply for third-party approval.
Dedicated R&D Team
With fully appointed laboratory resources and decades of hands-on experience, we work closely with customers to choose the right candidates off-the-shelf or re-engineer based on performance requirements. Since our material portfolio includes PVC, TPE and blends, we have a broad range of solutions to choose from.