With robust bio-compatibility pre-testing, healthcare quality systems and change control standards in place, these ‘medical grade’ concentrates and pre-color formulations can help minimize risk and avoid high costs of non-compliance. ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission

Halogen free, flame retardant TPEs formulated to provide good flexibility, lower moisture absorption, good insulation, and RoHS compliance. OnFlex™ Thermoplastic Elastomers met soft-touch design requirements and met FDA compliance

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. 

Is there a benchmark of carbon emissions you need to reach? Reducing your carbon footprint can help reach carbon neutrality commitments to your stakeholders.

At the same time, manufacturers also need to consider product safety and regulatory compliance.

The hose manufacturer decided to explore other material options that would meet requirements such as excellent colorability, good surface appearance, high flow for optimal productivity, and of course, compliance with U.S.

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). •    Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF). •    Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).  

RoHS Compliance

Regulatory compliance for aqueous, acidic, alcohol and fatty food applications are available with GLS thermoplastic elastomers.

However, until recently, these bio-based polymers were used in packaging and consumer plastic products, and most were not assessed for compliance with healthcare regulations.