OnFlex™ Thermoplastic Elastomers met soft-touch design requirements and met FDA compliance Avient's TPEs and engineered materials for auto-injector pens offer excellent chemical and impact resistance, good self-lubrication functions, durability to extend product life, and compliance with biocompatibility and food-contact safety regulations. 

Achieving this certification signifies Avient's dedication to maintaining the highest standards of quality, safety, and regulatory compliance in the production of materials and solutions for the healthcare sector. The ISO 13485 certification signifies that these products are manufactured and delivered with the highest level of quality and compliance.  

Product designers in the kitchenware and houseware industry are looking for materials that can meet the increasing demand for food safety and compliance, while also seeking more sustainable content,” said Flight Xu, general manager of Specialty Engineered Materials Asia for Avient, “Our innovative TPEs can meet the regulatory challenges, including FDA, EU10/2011 and China GB standard, and enhance safety without compromising performance or design freedom. These materials have good weather resistance, enhanced flexibility and good sealing performance, and include FDA-compliant and medical grades

The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging. Other regulatory compliance documentation is available upon request as well. This compliance testing, combined with the support of our healthcare experts, can make transfers of projects involving custom products from one region to another easier and faster.

The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging. Other regulatory compliance documentation is available upon request as well. This compliance testing, combined with the support of our healthcare experts, can make transfers of projects involving custom products from one region to another easier and faster.

Regulatory Compliance This is occurring globally and can range in the level of compliance required.

These scavengers can also lead to the formation of non-intentionally added substances (NIAS) that can accumulate and pose compliance risks. Importance of Quality and Compliance By addressing the gaps that limit recyclability and providing compliance with regulatory standards, the industry can move toward a more sustainable future.

These scavengers can also lead to the formation of non-intentionally added substances (NIAS) that can accumulate and pose compliance risks. Importance of Quality and Compliance By addressing the gaps that limit recyclability and providing compliance with regulatory standards, the industry can move toward a more sustainable future.

These scavengers can also lead to the formation of non-intentionally added substances (NIAS) that can accumulate and pose compliance risks. Importance of Quality and Compliance By addressing the gaps that limit recyclability and providing compliance with regulatory standards, the industry can move toward a more sustainable future.

The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging. Other regulatory compliance documentation is available upon request as well. This compliance testing, combined with the support of our healthcare experts, can make transfers of projects involving custom products from one region to another easier and faster.