Case study

INFINO® High flowability EtO sterilization PC ML-1020R for Dialyzer Filter


INFINO® High flowability EtO sterilization PC ML-1020R for Dialyzer Filter

Excellent material solution with excellent flowability for the molding of complex structures

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The Challenges

The Dialyzer Filter is a product that allows the patient's blood to flow through a dialysis machine, screens out the waste with a filter and injects the blood back into the patient's body. 

This product has a very complicated structure to smoothly circulate the blood, whose components include a lid for fluid infusion, a joint part on both sides of the screw and an internal double backflow prevention mechanism. As a result, it is difficult to achieve high precision and moldability during the production process. At the same time, what is needed is a high-quality material optimized for the Dialyzer Filter. The material should come with various biocompatibility certifications as well as durable material properties and transparency against EtO (Ethylene Oxide) sterilization treatment.

The Solutions

To meet these demands, LOTTE Chemical proposes INFINO®  PC ML-1020R material solution. 

LOTTE Chemical’s INFINO®  PC ML-1020R has achieved a high level of flowability and dimensional stability, thereby providing necessary moldability for the precision production of complex structures used in the Filter and solutions to the above-mentioned technical issues.

In general, the materials used in the Dialyzer Filter require USP Class V certification to prevent infections that can occur when it handles the circulation of blood, but INFINO®  PC ML-1020R material from 

LOTTE Chemical has secured USP Class VI certification, which is higher than Class V, as well as ISO-10993 (biological evaluation of medical devices) to ensure product safety. In addition, the use of high-purity and stable raw materials means that the production process generates near-zero impurities, making it possible to maintain the product without compromising transparency and material properties even after EtO (Ethylene Oxide) sterilization treatment.

LOTTE Chemical has registered INFINO®  PC ML-1020R with the US FDA DMF (Drug Master File), fully complying with the related pharmaceutical regulations for raw material information and process units in a way that enhances the credibility about the quality of the material.

Key Features

• High-flowability & Transparent

• Biocompatibility certification  (ISO-10993, USP Class VI)

• EtO Sterilization material

• To ensure Food contact test report (FDA, EN10) 

• To register USA FDA DMF (Drug Master File) 

Customer Benefits

• High flowability material(Surface quality optimization)

• Excellent dimensional stability and moldability → To ensure injection stability

Woosuk Chei│ Application Development Senior Manager

T +82-31-596-4672

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※ The content above is information regarding a case that has been applied to a certain customer. It does not make any explicit or implicit guarantee or warranty regarding the safety or utility of the service. Furthermore, the content of this document is not legally binding and suitability issues regarding final use must be determined by the user, and the user alone is responsible for the outcome. The values and information specified in this document may change without prior notice for quality enhancement of the product. LCC-C-122019