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ELIX@EOS ELIX TEAM
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Healthcare

ELIX medical grades meet the stringent requirements of the Medical Device Industry and include two USP Class VI and ISO 19993 biocompatibility grades, which have registered device and drug master file approvals for use in medical and food-contact applications, both in the European and US markets.

We offer leading solutions for the medical industry with emphasis on regulatory compliance, product safety and a global supply strategy. ELIX counts among our customers with the leading European and US medical injection molders and global pharmaceutical companies.

Benefits

ELIX medical grades offer many benefits for healthcare applications:

  • Balance of good processability (optimum flow) and mechanical properties.
  • Excellent surface quality with high gloss finish and customized colours.
  • Full compliance with medical regulations.
  • Sterilisation (gamma radiation, ethylenoxide) and excellent mechanical property retention under typical sterilisation doses of 25-50Gy.
  • Hydrolytic stability over time at elevated temperatures.
  • Resistance to a broad range of chemicals and body fluids.
  • Tough and durable.
Healthcare
Healthcare

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APPLICATIONS

INFUSION SYSTEM

  • Connectors
  • Caps
  • Spikes
  • Slide Clamps
  • Roller Clamps

RESPIRATORY DEVICES

  • DPI (Dry Powder Inhaler)
  • MDI (Metered Dose Inhaler)

AUTO INJECTION

  • Lancing Devices
  • Insulin Pen
  • Auto Injection Pens

OTHERS

  • Housing for Medical Devices
  • Closed System Transfer Device

M203FC

MAJOR BENEFITS

High gloss

High flow

TYPICAL APPLICATIONS

Respiratory devices, Auto Injection devices, Medical Housing

VIEW PRODUCT

M205FC

MAJOR BENEFITS

High gloss

High rigidity

TYPICAL APPLICATIONS

Infusion System

VIEW PRODUCT

M545TF

MAJOR BENEFITS

High gloss

High flowability

TYPICAL APPLICATIONS

Food contact applications

Toys

Cosmetics packaging

VIEW PRODUCT

REGULATORY COMPLIANCE

General

   DMF – Type III

   Letter of Authorization

Pharmacopoeia

Europe

    EU, 7 th Edition Chap 3.2.2.

   “Plastics Containers and Closures”

Japan

   JP, 16 Edition, G7

   “Plastics Containers for Pharmaceutical Use”

US

   USP Class VI

   Up to 30 days human contact duration

Biocompatibility – ISO 10993-1

   Biocompatibility Tests for Cytotoxicity, in Vitro Hemocompatibity etc

Food contact

   EU Regulation no. 10/2011

   FDA regulation 21CFR

   Germany, BfR - Recommendations

Others

   REACH compliant products

   RoHS 2011/65/EU complaint products

   BSE/TSE absence of the risk

   Non use of endocrine effective substances

ELIX commitment with the Healthcare Industry

Product Formulations: No-change agreement of up to three years*

Quality Assurance of Raw Materials & Intermediates / Dedicated Quality Management Team:

  • Special raw material supplier selection and homologation process.
  • Specific inwards testing on all raw materials.
  • Specific intermediate selection for medical grades.
  • Specific testing of final products for medical grades (e.g., residual monomers).
  • Continuous improvements in all processes.
  • Close cooperation with customers to meet exacting quality standards.

Sample Storage: Extended sample storage for three years.

Colour Development:

  • Special selection and listing of FDA- and EU-FC-approved pigments and additives.
  • Fast and competent colour development.
  • European database of more than 120 matched colours.
  • Recognised as industry benchmark in the medical industry.

Highly Experienced Technical Service:

  • Technical support all along the value chain (processing, design, production).
  • Long-term experience.
  • Trouble Shooting online and in-house at the customer’s facility.

* In connection with long-term supply agreement.

CONTACT US

For inquires please contact our sales team.