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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

 Mitsubishi Chemical Performance Polymers(MCPP-AP) Asia Pacific office in Singapore is now one of Asia’s Thermoplastic Elastomers(TPE) distributor in the region.   

  • Our plant in Yokkaichi, Japan is manufacturing high quality TPE for the region.
  • SEBS Rabalon TPE has good appearance and excellent flexibility with rubber-like elasticity, ease of processability, excellent weather and heat resistance with excellent hygienic properties with grades specially developed for medical and food applications.
    It also has excellent tactility(QE Series) abrasion and scratch resistance.
    Zelas are used for manufacturing Rubber/Silicon like Components, Syringe Gasket and Gasket for bottles and syringe bulbs or medical tubing etc.
  • Zelas polymers product range is comprised of 4 groups covering a wide range of properties, designed for film, tube and injected components for medical applications:
  • i) R-TPO for film manufacturing or Injection Molding

    ii) TPE: Modified elastomer with rubber/PVC like behavior for extrusion or Injection Molding

    iii) Tie Layer resin: adhesive/binder for multi-layer film extrusion

    iv) Barrier material for long shelf life film

  • This Olefin Base Zelas TPE has excellent heat resistance like homo-polypropylene but very flexible has good balance between heat resistance and transparency. They can be easily sealed and peeled (Infusion Double Bag) and has good compatibility with Polyolefin as a modifier.
  • Can be use in Medical Packaging like Infusion Solution Bag and other medical equipment, Food Packaging -Caps
  • Medical Zelas TPE all have Japanese Pharmacopeia XV testing and are widely used in the Japanese and Asian companies. We can recommend and help your company select the most appropriate grade for your company’s product application. 
  • Telfabloc is easy to process in Injection and extrusion. Rheology may also be adapted for hollow parts manufacturing(blow-extrusion, injection-blow) as well as blow-extrusion and recently developed 3D printing-FDM process.

See: www.mcpp-global.com under Zelas and Tefabloc

The industries that we service are Medical & Healthcare, Packaging, Consumers & Electronics.  

 

 

 

 

 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993