CSA International is an independent product safety certification organization that helps achieve compliance with US and Canadian standards.  As an intermediate supplier, Avient’s manufacturing facilities are not required to register with nor be directly held to the FDA’s specific good manufacturing practice requirements. FDA Drug Master Files and Medical Application Files. 

Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.   Following the mass balance chain-of-custody approach, the amount of bio-based content is tracked through segregated bookkeeping and provided in the sustainability declaration for the Mevopur healthcare bio-based portfolio. We’ve shown that increasing the sustainability of healthcare products without compromising regulatory compliance is possible if we all work together.

These unique MEVOPUR™ concentrates use pre-tested ingredients and prescribed manufacturing practices to help customers achieve compliance with pharmaceutical packaging regulations through 2025 and beyond.  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. They are also approved for food contact in accordance with US FDA and EU norms.

Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. Documentation supporting relevant product safety and compliance data is available to all customers. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).

Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. Documentation supporting relevant product safety and compliance data is available to all customers. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).

Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. Documentation supporting relevant product safety and compliance data is available to all customers. Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).

The new materials have been pre-tested for compliance with the United States FDA requirements under 21 CFR 177.2600 for repeated-use applications and the European standard 10/2011 for food contact. However, compliance does not depend solely on the right polymer formulation, but also on the design of the finished article.

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. 

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. 

We also navigate the complex regulatory landscape, helping you meet the latest safety and compliance standards.  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.