Materials for
Healthcare Applications
The brand names ALPHAMED, EVOPRENE, MEXIFLEX, VINASTAB, and VYTHENE are trademarks of Alphagary/Mexichem.
Flexible and rigid PVC (polyvinyl chloride) compounds formulated with food-contact ingredients for extrusion and molding applications such as tubing (oxygen, blood, food, etc.), oxygen masks, connectors and various other medical and dental devices.
The EVOPRENE R-99 series are flexible TPE (thermoplastic elastomer) compounds for extrusion & molding applications, formulated with indirect food-grade ingredients US FDA 21 CFR, EU 10/2011, 1935/2004. Designed for healthcare medical and pharma applications that require biocompatibility and cytotoxicity testing.
Flexible TPU (thermoplastic urethane) compounds that are alloys of vinyl and polyurethane, designed for applications requiring higher elongation values (ability to stretch). Materials are tough, flexible, transparent and kink resistant, and are ideal for applications exposed to repeated pressure and movement (for example, hemodialysis tubing)
Additives for PVC
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.