Warehouse: Ensure smooth operations and timely deliveries

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).

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).

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).

MEDICAL EQUIPMENT MANUFACTURER C L O S E D S Y S T E M D R U G T R A N S F E R D E V I C E • A new material for a seal inside the next generation of closed system drug transfer device • Compliance with stringent regulatory standards: • Biocompatibility to ISO10993 • USP VI compliance • Provided regulatory support services and expertise throughout extensive medical approval process • Provided a custom formulation compliant with the highest healthcare regulatory standards • Enabled material to be manufactured and shipped globally Custom Versalloy™ HC 9220-90 Formulation KEY REQUIREMENTS WHY AVIENT?

Closed System Drug Transfer Device Custom Versalloy™ HC 9220-90 formulation provides regulatory compliance for drug transfer device 

Closed System Drug Transfer Device Custom Versalloy™ HC 9220-90 formulation provides regulatory compliance for drug transfer device 

Closed System Drug Transfer Device Custom Versalloy™ HC 9220-90 formulation provides regulatory compliance for drug transfer device 

Closed System Drug Transfer Device Custom Versalloy™ HC 9220-90 formulation provides regulatory compliance for drug transfer device 

Most TPEs fall into the Food and Drug Administration’s Generally Recognized as Safe (GRAS) category. Glass or other heavier materials can be replaced with a lighter, TPE-made product so you can fit more inventory on delivery trucks.