Product Grade/Solution
ELIX M203FC and ELIX M205FC grades.
Description
M203FC and M205FC are the two ELIX medical grades with registered device and drug master file approvals for use in medical applications. These materials are biocompatible with up to 30 days human contact duration according to USP Class VI and ISO 10993-1, and meet the stringent requirements of the medical device industry
In addition, ELIX assumes responsibility for pigment compliance, including more than 130 colours approved for use in medical device applications.
Typical Application
Infusion systems (connectors, caps, spikes, slide clamps, roller clamps), respiratory devices (DPI, MDI), auto injection (lancing devices, insulin pen, autoinjector pens), housing for medical devices, closed system transfer device.
R+D concept
“Our project aim was to offer leading solutions for the medical industry, with emphasis on regulatory compliance, product safety and a global supply strategy ”
Market Field
Medical applications.
Features Benefits
Full compliance with medical regulations, including the pigments and additives used.
No-change formulation agreement including colour recipe and extended sample storage for 3 years.
Balance of good processability and mechanical properties.
Sterilisation (gamma radiation, ethylenoxide) and excellent mechanical property retention under typical sterilisation doses of 25-50 KGy.
customised colours. grade. products.
Product stewardship service: surveillance on changes in medical regulatory framework and formulation optimisation within legislational limits.
Fast colour development, with special selection of FDAand UE-FC-approved pigments and additives.
Highly experienced technical service, offering remote/onsite injection moulding support.
New material developments and solutions for the medical sector (laser marking, antimicrobial, 3D printing).
Grades supplied to leading medical injection moulders and global pharmaceutical companies both in Europe and the USA.
Learn more about ELIX Innovation (Portfolio of Solutions): https://www.elix-polymers.com/portfolio-solutions For enquires please contact transferknowledge@elix-polymers.com