Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols. All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings. 

Geon(TM) DB5323 Neutral TT Imp-Iso No-Stab Geon(TM) DB5324 Neutral TT Imp-Iso Stab

Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards. Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.

MAUVE DOOR, ISO FIX COVER HAZEL DOOR, ISO FIX COVER V2

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with: •    ISO 10993-1 and USP parts , (including class VI) •    European Pharmacopoeia, monograph 3.1.15 •    USP and •    elemental analysis, as per ICH Q3D

Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library