https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
FDA/EU compliance information available upon request
REMAFIN™ EP White Colorants
for Pharmaceutical Packaging
REMAFIN™ EP is a range of PE and PP based
masterbatches designed for protecting oral,
topical, parenteral, ophthalmic and nasal
pharmaceuticals by opacifying primary and
secondarypharmaceutical packaging.
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.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
https://www.avient.com/epic-special-effects-tips
10009PFXHDC Epic HD Clear 2 - 30 parts
Epic SFX Bases: Mix by weight Sculpture Base 50%, Plush Base 30%, Cork Base 20%.
https://www.avient.com/investor-center/news/avient-announces-third-quarter-2024-results
September 30
September 30
September 30
https://www.avient.com/resources/safety-data-sheets?page=6968
KDS PINK SWIRL 231C 30% PCR
SILVER MB 30% PCR
PP FR 8-6 LMS-1000
https://www.avient.com/resources/safety-data-sheets?page=2475
PP-H-30T BLACK
GRV-NY-032-SS-Nat
PP FR 8-6 LMS-1000
https://www.avient.com/resources/safety-data-sheets?page=1290
PG 60235.00 BU PP
GRV-PV-029-CM-RED #4
PP GARGOYLE GRAY
https://www.avient.com/resources/safety-data-sheets?page=902
PG 52726 PU PP
PG 53248 PU PP
GRV-UR-060-CU-Nat
https://www.avient.com/resources/safety-data-sheets?page=2305
90% PP/10% ELVALOY
80% PP 20% ELVALOY
X GRV-1314-1B (4.5 high SS)
https://www.avient.com/resources/safety-data-sheets?page=2518
GRV-NY-112-W-NAT
TOFFEE TO BE PP DC
PP FR 8-6 LMS-1000
https://www.avient.com/resources/safety-data-sheets?page=2585
X GRV-15790-01
522946 RED PP
PP FR 8-6 LMS-1000