https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Color can be combined with additives to
enhance performance and protection
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE
TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Available as pre-colored formulation or
concentrate and for use in different polymers
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU**
APPLICATION BULLETIN
* Design note: Effect colors require careful consideration of part design and
polymer flow paths to minimize visible flow lines.
https://www.avient.com/sites/default/files/2020-08/stan-tone-wdn-product-bulletin.pdf
%
Solids
Color
Index
pH
Typical
Weight
Lbs/Gal
WHITE
10WDN03
Titanium Dioxide,
Rutile
60 73 PW-6 9 16.7
YELLOW
12WDN01 Diarylide AAOT GS 35 43 PY-14 8.8 9.4
12WDN02 Diarylide HR RS 37 44 PY-83 8.8 9.6
12WDN03 Arylide GY RS 38 45 PY-74 8.8 9.2
81WDN01 Iron Oxide 55 63 PY-42 8.8 14.5
ORANGE
15WDN01 Pryazolone YS 40 45 PO-13 8.8 9.2
15WDN03 Dianisidine RS 35 37 PO-16 8.8 9.2
15WDN06 DNA Orange RS 31 43 PO-5 8.8 9.7
RED
22WDN01 Lithol Rubine BS 33 40 PR-57 8.8 9.8
21WDN01 Naphthol BS 35 43 N/A 8.8 9.5
25WDN01 Red 2B, Ca BS 34 41 PR-48:2 8.8 9.6
28WDN01 Red 2B, Ba YS 36 44 PR-48:1 8.8 9.5
82WDN02 Iron Oxide 57 66 PR-101 8.8 16
BLUE
40WDN01 Phthalocyanine RS 35 46 PB-15 8.8 9.7
40WDN03 Phthalocyanine GS 38 43 PB-15:3 8.8 9.8
GREEN
WDN-27822 Phthalocyanine BS 42 53 PG-7 8.8 10.5
VIOLET/MAGENTA
24WDN02 Carbazole 35 48 PV-23 8.8 9.6
24WDN03 Quinacridone 31 39 PV-19 8.8 9.6
24WDN05 Quinacridone 30 41 PR-122 8.8 10
BLACK
90WDN01 Carbon Black 45 49 PB-7 8.8 9.3
WDN
RS = Red Shade YS = Yellow Shade BS = Blue Shade GS = Green Shade HR = Heat-Resistant
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates and
ready-to-use formulations
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
FUNCTIONALITY TARGET APPLICATIONS
DRUG
DELIVERY
DEVICES
SYRINGES &
NEEDLES DIAGNOSTICS CATHETERS
Clarifying PP
Sorbitol-free for transparent
applications with reduced migration
and improved thermal stability
Lubricant—
permanent/
non-migrating
Fast acting reduction in friction
for wide variety of polymers such
as PP, ABS, POM, PC
Protection from
UV in transparent
applications for PP,
PE, PETG, COP
UV blocking in 290-450nm with
no impact on clarity; can be
combined with colors (e.g., amber)
Antistatic ready-to-
use solution for PP,
ABS, PC/ABS
Permanent/non-migrating;
fast decay time independent
of % relative humidity
Gamma/e-beam
sterilization
protection of the
polymer
Preserving the properties of
PP and COC/COP; reduction
in yellowing using Color
Compensation Technology (CCT)
Reduced material
consumption/cycle
time—nucleation
Fast acting new generation
nucleant for PE and PP; improved
thermal and mechanical properties
allows wall thinning; reduction of
tolerance/dimensional problems
between different colors
Laser marking
replacing ink
printing/labels
Solvent-free, high-speed
identification for Nd/YAG laser
for PE,PP, ABS, PC, POM
Antioxidants for
PE, PP, TPE
Thermal protection during
converting/downstream sterilization
Brand protection/
anticounterfeit
Covert and non-covert systems
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Available for use in a wide range of polymers
including polyolefins, styrenics, polycarbonate
and alloys, polyester, POM
• Functionality can be combined with colorants
into convenient combination concentrates or
formulations
REGULATORY SUPPORT
• Pre-tested raw materials:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
FUNCTIONALITY TARGET APPLICATIONS EBM/IBM CONTAINERS CLOSURES FILM
COMBINATION
DEVICES
Clarifying PP
Sorbitol-free—possibilities in
packaging ocular solutions
Slip/torque reduction
Slip for PE, PP films, processing aid,
torque reduction for closures
Protection from UV in
transparent packaging
for PP, PE, PETG, COP
UV blocking in 290–450nm with
no impact on clarity
Antistatic ready-to-use
solution for PE films e.g.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS
• Designed for Nd:YAG lasers operating between
1060-1070 nm
• Available for different polymers including
PP, PE, PC, PBT, POM, ABS, MABS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Can be designed for dark marking on natural
or white/light colored background or light
marking on black/dark background
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing sites, providing global
consistency and increased security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without animal-
derived substances
• Standard concentrates in a PE carrier and
on request in PP
• Pre-colored formulations can be supplied in
specific resins selected for the application
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III)
• Food contact established with FDA/EU*
APPLICATION BULLETIN
DRUG TYPE COLOR DESCRIPTION
PANTONE
REFERENCE
AVIENT PRODUCT
CODE PE BASED
Adrenergic agonist
combinations
Light Green 373 C PE6M176349
Adrenergic agonists Purple 2583 C PE4M176057
Anti-infectives Tan 467 C PE8M176130
Anti-inflammatory,
nonsteroidal
Grey Cool Grey 4 C PE7M176184
Anti-inflammatory,
steroids
Pink 197 C PE3M176237
Anti-inflammatory,
immunomodulators
Olive Green 5763 C On request
Beta-blockers Yellow Yellow C PE1M176160
Beta-blocker combinations Dark Blue 281 C PE5M176272
Carbonic anhydrase inhibitors Orange 1585 C PE2M176089
Cytotoxic Black 6 C PL9M176008
Miotics Dark Green 348 C PE6M176267
Mydriatics and cycloplegics Red 1797 C PE3M176236
Prostaglandin analogues Turquoise 326 C PE5M176273
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2021-10/gls-tpes-with-antimicrobial-technologies-product-bulletin.pdf
PRODUCT BULLETIN
VERSAFLEX™ GP
2810-40N AM
VERSAFLEX™ CE
3120-65* AM
ONFLEX™ LO
7120-45 AM
Applications
Personal care grips
Consumer packaging
Consumer electronics
Charging stations
HVAC seals
Cup holder mats
Color Natural Natural Natural
Durometer, Shore A 45 66 45
Specific Gravity
(kg/m3)
0.87 1.14 1.13
Tensile Strength
(PSI)
650 1200 585
Elongation % 700 600 685
Modulus @ 300%
|(PSI)
260 585 300
Injection Moldable Yes Yes Yes
OM Substrate PP PC, ABS, PC/ABS, COPE PP
TECHNICAL PROPERTIES
*UL listing does not apply; testing can be completed if required by the customer
Copyright © 2021, Avient Corporation.
https://www.avient.com/sites/default/files/2022-01/Avient Sarl%2C Germany Branch Extract Dec 23 2021.pdf
Handelsregister B des Amtsgerichts Mannheim Nummer der Firma:
Seite 1 von 2
HRB 731450
Nummer
der
Eintragung
a) Firma
b) Sitz, Niederlassung, inländische
Geschäftsanschrift, empfangsberechtigte
Person, Zweigniederlassungen
c) Gegenstand des Unternehmens
Grund- oder
Stammkapital
a) Allgemeine Vertretungsregelung
b) Vorstand, Leitungsorgan, geschäftsführende
Direktoren, persönlich haftende Gesellschafter,
Geschäftsführer, Vertretungsberechtigte und
besondere Vertretungsbefugnis
Prokura a) Rechtsform, Beginn, Satzung oder Gesellschaftsvertrag
b) Sonstige Rechtsverhältnisse
a) Tag der Eintragung
b) Bemerkungen
1 2 3 4 5 6 7
1 a)
PolyOne S.à r.l., Germany Branch
b)
Gaggenau
Geschäftsanschrift:
Adolf-Dambach-Straße 2, 76571 Gaggenau
Zweigniederlassung der "PolyOne S.à r.l."
mit Sitz in Pommerloch / Luxemburg
(Registre de commerce et des sociétés
B226205)
c)
Den Vertrieb und den Großhandel von
Fertigerzeugnissen, die unter anderem aus
ein- und mehrschichtigen
thermoplastischen Platten,
Polymermischungen und Farbkonzentraten
sowie klaren thermogeformten
Kunststoffbehältern bestehen, wobei die
Tätigkeiten für die das Gesetz besondere
Qualifikationen oder Erlaubnisse
vorschreibt, die von der
Zweigniederlassung nicht erfüllt oder
gehalten werden, ausdrücklich
ausgeschlossen sind.
12.000,00
EUR
a)
Jeder Geschäftsführer vertritt einzeln.
a)
10.09.2018
Kretzler
2 b)
Bestellt als
Geschäftsführer:
Fielding, Gary J., Chesire / Vereinigtes
Königreich, *20.09.1963
Bestellt als
Geschäftsführer:
Potoczny, Zaneta Gabriela, Mersch / Luxemburg,
*17.10.1974
Ausgeschieden als
Geschäftsführer:
Machin, Geneviéve Elizabeth, Luxemburg /
Luxemburg, *31.03.1972
a)
17.03.2020
Knauf
Abruf vom 27.12.2021 17:13
Handelsregister B des Amtsgerichts Mannheim Nummer der Firma:
Seite 2 von 2
HRB 731450
Nummer
der
Eintragung
a) Firma
b) Sitz, Niederlassung, inländische
Geschäftsanschrift, empfangsberechtigte
Person, Zweigniederlassungen
c) Gegenstand des Unternehmens
Grund- oder
Stammkapital
a) Allgemeine Vertretungsregelung
b) Vorstand, Leitungsorgan, geschäftsführende
Direktoren, persönlich haftende Gesellschafter,
Geschäftsführer, Vertretungsberechtigte und
besondere Vertretungsbefugnis
Prokura a) Rechtsform, Beginn, Satzung oder Gesellschaftsvertrag
b) Sonstige Rechtsverhältnisse
a) Tag der Eintragung
b) Bemerkungen
1 2 3 4 5 6 7
3 a)
Firma geändert; nun:
Avient S.à r.l., Germany Branch
b)
Daten der Hauptniederlassung geändert;
nun:
Zweigniederlassung der "Avient S.à r.l." mit
Sitz in Pommerloch / Luxemburg (Registre
de commerce et des sociétés B226205)
b)
Ausgeschieden als
Geschäftsführer:
Fielding, Gary J., Chesire / Vereinigtes
Königreich, *20.09.1963
Bestellt als
Geschäftsführer:
Merklein, Norbert, Kronberg im Taunus,
*03.05.1964
a)
Der geänderte Gesellschaftsvertrag der Hauptniederlassung
wurde zum Handelsregister eingereicht.
https://www.avient.com/sites/default/files/2022-10/Tossiat-IATF 16949-2016 POLYONE FRANCE SAS.pdf
and the applicable customer specific requirements
Revision:11
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
None
Bureau Veritas Certification Certificate N°: FR072877FR072877- IATF- IATF
IATF Certificate N°: 442787442787
Date Of Expiration: 01-February-202501-February-2025
Date Of Certification: 02-February-202202-February-2022
PRODUCT(S) DELIVEREDPRODUCT(S) DELIVERED
colour with additive concentrates for thermoplastic resins
and speciality compounds obtained by mixing and extrusion
PERMITTED EXCLUSION(S)PERMITTED EXCLUSION(S)
SCOPESCOPE
Design and manufacturing
Bureau Veritas Certification certify that the Quality Management System of the above organisation
has been audited and found to be in accordance with the requirements of
Route de la Vavrette, 01250, TOSSIAT FranceRoute de la Vavrette, 01250, TOSSIAT France
PolyOne France TossiatPolyOne France Tossiat
Awarded to
Certificate of ApprovalCertificate of Approval
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
REMOTE SUPPORT FUNCTION(S)REMOTE SUPPORT FUNCTION(S)
(The official document is in English.
Revision:11
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
Bureau Veritas Certification Certificate N°: FR072877FR072877- IATF- IATF
IATF Certificate N°: 442787442787
Date Of Expiration: 01-February-202501-February-2025
Date Of Certification: 02-February-202202-February-2022
Route de la Vavrette, 01250, TOSSIAT FranceRoute de la Vavrette, 01250, TOSSIAT France
PolyOne France TossiatPolyOne France Tossiat
Awarded to
Appendix to the Certificate of ApprovalAppendix to the Certificate of Approval
Name Address Scope
AVIENT
LUXEMBOURG
ROUTE DE BASTOGNE, 19, 9836,
POMMERLOCH Luxembourg
Logistic, Supplier Management,
Purchasing
PolyOne Europe
Logistics
7 rue Blériot, 4460, GRACE HOLLOGNE
Belgium
Warehousing
Polyone Europe ul.