Medical Device Qualified Supplier Directory

 

Enplas Company Profile

 

www.enplaslifetech.com/
E: [email protected]
T: (828) 633-2250

Address
230 Sardis Road, Asheville, North Carolina, 28806, United States
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Qualifications: ISO 13485

Markets Supplied: Worldwide

 

Enplas is a global leader in Engineering Plastic solutions. Our life science business supports many bio-technology market leading clients' development and mass production efforts for their customized plastic consumables. Products include microfluidics, cartridges, fluid control sealing interface components and assemblies, and other components for in-vitro diagnostic (IVD) e.g. PCR, NGS, single-cell analysis, immunoassay, etc.

We are happy to support customers’ life science product development with our capabilities listed below, or any other – please inquire any time.

Microfluidics: Micro-features and channels with minimum channel depth 5 micro meters / surface roughness < Ra 0.1 micro meter can be designed with our novel IP. Thermal bonding film lamination available as well. Enplas can also optimize the microfluidics design to achieve your targeted fluid function or droplet generation. We have the know-how to control droplet size by controlling the channel shapes and dimensions. See more at http://enplas.co.jp/english/business/bio/. 

Fluid sealing interface: Chip-to-world interface manufactured with thermoplastic elastomer (TPE). TPE Overmolding available to ensure reliable sealing and cost reduction from eliminating assembly process. Interfaces can be customized to fit between any component, be it chip to pipette / cartridges / other chips, between reagent bottle cap lids and containers, or cartridge to tubes, etc.

Other components and assembly: Cartridges, valves, fittings, containers etc. can be manufactured and assembled with microfluidics or fluid sealing interfaces. Both injection molding and assembly will be carried out in our class 7 cleanrooms (lowest particle count 500). We handle engineering grade or transparent materials such as PP, PC, COP, COC, PMMA, and many others. Endotoxin-free products are available too.

Life Science Prototype and Production in the U.S.: We have multiple locations in the U.S. conducting R&D, prototype, mass production and assembly for life science products. Our facility in Asheville, North Carolina has comprehensive capability from Design for Manufacturability (DFM) support, tool design, in-house mold making, cleanroom injection molding, cleanroom assembly, inspection, and Just-in-Time (JIT) inventory. Provides quick turnaround on prototype or mass production quality tooling for being a one-stop shop for all services, with engineering and manufacturing expertise. Other global life science R&D, prototype and mass production sites include Cambridge, UK, and multiple locations in Japan.

Quality Assurance: Our U.S. life science production facility is ISO 13485 certified, and has a rigorous quality assurance system established. Enplas utilizes state of the art equipment to ensure precision metrology. Strict inspection procedures are in place for quality control and accurate traceability.  

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