MELITEK manufacture and offer broad range of compounds for healthcare that are specially customized for pharmaceutical packaging, medical devices and diagnostics applications.
MELITEK´s innovative elastomer and polymer+ compounds are market and sold under the meliflex trade name.
On the subpages to the left or below, you can read more about the full meliflex product range, as well as how we produce, test and comply with regulatory standards.
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meliflex products are produced on dedicated high efficiency state-of-the-art production lines installed in a clean environment (unclassified). Each production line is segregated in separate over pressurized production rooms to avoid foreign contaminations and pellet flow is kept in closed system to limit exposure to environment.
MELITEK produces all our compounds in line with GMP (EC 2023/2006) and with a dedicated medical service concept which guarantees full lot traceability, change control management and extensive line clearance procedures to ensure high uniform quality.
Our quality policy is to deliver “Quality on Time” to our valued customers.
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meliflex offers an environmentally sound replacement for materials such as flexible PVC, Polyurethane and latex. Our meliflex materials are non-hazardous and easily disposable without concerns of dioxin emissions and hydrogen chloride which typically is a concern during the incineration of PVC.
At MELITEK, we believe that only by our Medical Service Package combined with rigorous lot testing of the final compound, we can ensure suitability for use for our customers. Reference meliflex materials are tested with independent international test institutes to certify that they comply with medical standards such as ISO 10993, USP and European Pharmacopoeia. Regulatory certification on customized grades are offered as per agreements with our customers.
/Secondary%20content/compliance%20smalt%20a.jpg "Regulatory compliance")