https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured under change control principles
beyond CAS number (similar level as MEVOPUR
concentrates), reducing risk of change
• Free from animal-derived substances and
phthalates
• Suitable for blown film, injection molding,
blow molding and extrusion
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP chapters , including Class VI,
a requirement for ophthalmic and nasal drugs
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
- USP and USP light transmission
• Registered Drug Master File (Type III)
• Food contact compliance established with
FDA/EU*
APPLICATION BULLETIN
CARRIER
MATERIAL
PIGMENT
CONTENT/TYPE
LIGHT
FASTNESS
THERMAL
STABILITY
PRODUCT
CODE
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
Healthcare use limitations apply—see below.
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=3
Mevopur™ Polymer Colorants and Additives
Mevopur™ Bio-based Polymer Solutions for Healthcare
https://www.avient.com/resource-center?document_subtype=0&document_type=221&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=3
Mevopur™ Polymer Colorants and Additives
Mevopur™ Bio-based Polymer Solutions for Healthcare
https://www.avient.com/industries/healthcare/medical-devices-equipment/imaging-technology
Mevopur™ Healthcare Functional Additives
Mevopur™ Healthcare Colorants and Formulations
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性
生产符合高于CAS编号级别的变更控制原则
(与MEVOPUR母粒类似),降低变更风险
不含动物源性物质和邻苯二甲酸盐
适用于吹膜、注塑、吹塑和挤出
•
•
•
注册药品主文件(III型)
食品接触符合FDA/EU*要求
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章,包括VI级别,符合眼
科和鼻腔用药物要求
- 欧洲药典3.1.3/3.1.5(聚烯烃)
- 美国药典(聚乙烯)
- ICH Q3D 杂质元素
- USP和USP,透光率
•
•
•
载体材料 耐光性 热稳定性 产品代码颜料含量/类型
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
适用医疗保健使用限制—见下文。
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
Mevopur™ Healthcare Colorants and Formulations
https://www.avient.com/resources/safety-data-sheets?page=6879
RED HOUSING CMPD II
MEVOPUR-BLUE
RED PMMA
https://www.avient.com/resources/safety-data-sheets?page=7136
MEVOPUR VAL WHITE
The more complete the information, the more accurate the search result - e.g. a search that only includes the number "8700" or the word "RED" will yield very large results sets).
https://www.avient.com/resources/safety-data-sheets?page=7076
PP MEVOPUR WHITE
RED POM 3
RED PC/ABS
https://www.avient.com/resources/safety-data-sheets?page=7103
MEVOPUR VAL DK BLUE
The more complete the information, the more accurate the search result - e.g. a search that only includes the number "8700" or the word "RED" will yield very large results sets).