Remafin™ EP White Colorants
Meets Pharma Packaging Compliance
The Remafin™ EP white colorants portfolio is specially designed for pharmaceutical packaging. The range is targeted for use in the production of pharma containers for parenteral, ocular, and nasal drugs. The colorant solutions are available in PP and PE (HDPE and LDPE) and produced with ingredients tested to European Pharmacopeia 3.1.3 and 3.1.5 as well as to USP chapters <87>, <88> including class VI (a requirement for ophthalmic and nasal drugs) and USP <671> and <661.2> (light transmission). High loading and optimized dispersion of pigments provide a cost-effective way to meet light transmission requirements while fully supporting regulatory compliance for packaging materials.
Avient also offers pre-tested colorants for caps and closures used in pharmaceutical packaging.
Impact
- Supports regulatory compliance for pharmaceutical packaging materials
- ISO 10993-1, USP <87> and <88> (class VI), USP <661.1>, European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP <671> and <661.2> evaluations reduce risk of non-compliance during regulatory submission
- Registered Drug Master File (DMF)
- Documented change control beyond CAS number
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