To support customers’ Device Master File submission for healthcare materials, Avient has developed and submitted a type III Drug Master File (FDA) for these colorants.

Beyond food and beverages, drugs, cosmetics, and any other consumer goods used or applied by humans, the regulation extends to manufacturing processes and the compliance of packaging products.

Food and Drug Administration (FDA).

Food and Drug Administration (FDA) food contact requirements and the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) European regulation.

According to conference co-chairman Bernard Powell, senior product manager for PolyOne’s distribution business, the conference will offer the medical community an opportunity to focus narrowly on the benefits of elastomers in healthcare for application areas such as medical devices, pharmaceutical packaging, drug delivery devices, prosthetics, and orthopedics.

Seeking a partner that could provide consistency and local sourcing in North America and Asia, as well as establish drug master files for the United States and China, the Andwin Scientific team met with Avient, which has a range of technologies engineered to meet health care industry needs and regulations.

Food and Drug Administration’s (FDA) draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” recommends the use of appropriate human factors analysis, testing and validation during the design phase of medical devices to reduce user-related hazards and errors.

Bringing associate members on board with a strong track record of delivering specialty solutions broadens our technical knowledge base,” explains Cheryl Kreindler, ZDHC Program Manager. PolyOne is committed to environmentally sound practices, services and solutions that deliver value for our customers and the wider industries we serve,” added John Van Hulle, president of global color, additives and inks for PolyOne.

CORE™ Non-Phthalate Plastisols delivered a non-phthalate plastisol formulation that improved processing and met regulatory requirements These additives are created to enhance bioplastics so you can continue delivering top-end products to the market.

Most TPEs fall into the Food and Drug Administration’s Generally Recognized as Safe (GRAS) category. At Avient, we use a collaborative approach to deliver the specialty polymer formulations, services and sustainable material solutions specific to your application and property needs.