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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.
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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
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/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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.
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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.
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.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are available on request • Production under ISO 13485 / GMP quality system with change control management • Fingerprinting of raw materials and routine batch testing • Extractability evaluated in hexane, isopropanol, and water according to ISO 10993 part 18 REGULATORY SUPPORT • Raw materials are pre-tested to biologically- evaluated raw materials using ISO 10993-1 and USP chapters , Class VI • DMF/MAF documentation filed with the FDA for all standard colors APPLICATIONS MEVOPUR LQ formulations can be applied in demanding applications including: • Medical devices such as catheter tubing & connectors, syringe tips, and needleless connectors • Skin contact devices such as wearables or soft-touch surfaces of medical devices PRODUCT BULLETIN MEVOPUR™-LQ YELLOW (PMS1205C) Product Code FZ1M415005 MEVOPUR™-LQ TRANS YELLOW Product Code FZ1M415006 MEVOPUR™-LQ BLUE (PMS292C) Product Code FZ5M415008 MEVOPUR™-LQ TRANS BLUE Product Code FZ5M415009 MEVOPUR™-LQ RED (PMS198C) Product Code FZ3M415008 MEVOPUR™-LQ TRANS RED Product Code FZ3M415009 MEVOPUR™-LQ GREEN (PMS346C) Product Code FZ6M415008 MEVOPUR™-LQ TRANS GREEN Product Code FZ6M415009 MEVOPUR™-LQ VIOLET (PMS2655C) Product Code FZ4M415003 MEVOPUR™-LQ TRANS VIOLET Product Code FZ4M415004 CUSTOM-MADE Individual options Customized colors are also available to meet your needs, please contact us.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
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/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. for API handling Permanent/non-migrating; fast decay time independent of % relative humidity Antistatic masterbatch for PE films Cost effective, long-lasting, migrating type but with biological evaluation Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Please be aware that there are certain applications Avient’s Mevopur products have not been designed for, nor are they promoted or intended for use in: including, but not limited to long-term or permanent implants, birth control devices, or plastic surgery.
https://www.avient.com/sites/default/files/2020-09/stan-tone-hcc-product-bulletin-1.pdf
By varying ingredient ratios, a wide range of viscosities and color control are achieved to enhance metering capability and distribution.
KEY CHARACTERISTICS • Indoor or outdoor lightfastness • Heat stability • Non-phthalate pigments available • Additional options available using custom plasticizers APPLICATIONS Stan-Tone HCC dispersions are suitable for use in a variety of applications, including: • Coated fabric • Vinyl sealants • Adhesives • Wall coverings • Toys • Sporting goods • Footwear • Silk screen Stan-Tone Code Pigment Type Approx. % Pigment Specific Gravity Color Index Heat Stability Lightfastness WHITE HCC-12144 Titanium Dioxide, Anatase 61 1.89 PW-6 1 I/O C HCC-12145 Titanium Dioxide, Rutile 70 2.09 PW-6 1 I/O YELLOW HCC-12148 (a) Diarylide AAOT GS 35 1.09 PY-14 3 I HCC-12516 (a) Diarylide AAMX RS 30 1.07 PY-13 3 I HCC-12149 (a) Diarylide HR RS 22 1.04 PY-83 2 I/O (Mass) HCC-12194 Iron Oxide 70 2.08 PY-42 2 C I/O HCC-12503 Benzimidazolone GS 30 1.09 PY-151 2 I/O (Mass) HCC-5253 (b) Isoindolinone RS 30 1.12 PY-110 1 I/O ORANGE HCC-17394 Benzimidazolone RS 20 1.05 PO-36 2 I/O HCC-17747 Azo YS 30 1.11 PO-64 2 I/O HCC-33428 Dianisidine RS 29 1.06 PO-16 3 I/O (Mass) RED HCC-12156 (a) Red 2B, Ca Salt BS 30 1.12 PR-48:2 2 I/O (Mass) HCC-12160 (a) Red 2B, Ca Salt YS 33 1.12 PR-48:1 2 I/O (Mass) HCC-12158 (a) Pyrazolone YS 25 1.05 PR-38 2 C I/O (Mass) HCC-12159 Pigment Scarlet BS 38 1.21 PR-60:1 2 I/O (Mass) HCC-12196 Iron Oxide, Dark VBS 65 2.09 PR-101 1 I/O HCC-12197 Iron Oxide, Light BS 70 2.24 PR-101 1 I/O HCC-18653 Iron Oxide, Light VYS 70 2.23 PR-101 1 I/O HCC-11796 (a) Specialty Naphthol BS 32 1.06 PR-170 2 I/O (Mass) C HCC-12742 (a) Specialty Naphthol YS 30 1.07 PR-170 2 I/O (Mass) C HCC-2160 (b) Quinacridone BS 26 1.08 PV-19 2 I/O HCC-12309 Quinacridone YS 25 1.07 PV-19 2 I/O HCC-7707 Perylene Scarlet YS 25 1.04 PR-149 2 I/O HCC-15738 Diketo-Pyrrolo- Pyrrol YS 30 1.1 PR-254 1 I/O BLUE HCC-12164 Phthalocyanine GS 27 1.08 PB-15:3 1 I/O HCC-12166 Phthalocyanine RS 18 1.05 PB-15 1 I/O HCC-12168 Phthalocyanine RS-NC 32 1.11 PB-15:1 1 I/O HCC-12929 (c) Ultramarine 53 1.4 PB-29 1 I/O Stan-Tone Code Pigment Type Approx. % Pigment Approx. % Solids Color Index pH Typical Lightfastness GREEN HCC-12172 Phthalocyanine BS 17 1.07 PG-7 1 I/O HCC-12173 Phthalo Brominated VYS 25 1.16 PG-36 1 I/O HCC-10562 Phthalocyanine YS 30 1.15 PG-7 1 I/O HCC-12176 Chromium Oxide 80 2.8 PG-17 1 I/O VIOLET/MAGENTA HCC-17680 (c) Ultramarine Violet 50 1.46 PV-15 1 I/O HCC-2170 (b) Quinacridone Violet 30 1.09 PV-19 2 I/O HCC-14562 Quinacridone Magenta 25 1.06 PR-122 2 I/O HCC-26775 Benzimidazolone 20 1.03 PV-32 2 I/O HCC-33159 (a) Carbazole Violet 12 1.03 PV-23 2 I/O BROWN/TAN HCC-1286 (b) Iron Oxide, Tan HR 60 1.85 PBr-11 1 I/O HCC-12201 Iron Oxide, Light 71 2.21 PBr-6 2 C I/O HCC-12202 Iron Oxide, Dark 67.5 2.06 PBr-6 2 C I/O BLACK HCC-12203 Furnace-High Jet 18 1.06 PBk-7 1 I/O HCC-12204 Furnace-High Jet 6 1 PBk-7 1 I/O HCC-12205 Furnace-Low Jet 34 1.15 PBk-7 1 I/O HCC-12206 Furnace-Medium Jet 20 1.07 PBk-7 1 I/O HCC-18654 Furnace-Ultra High Jet 15 1.04 PBk-7 1 I/O HCC-14674 Iron Oxide 59 1.82 PBk-11 2 C I/O ALUMINUM HCC-12177 Aluminum 50 1.43 PM-1 2 I/O HCC RS = Red Shade YS = Yellow Shade VYS = Very Yellow Shade BS = Blue Shade VBS = Very Blue Shade GS = Green Shade NC = Non-Crystallizing HR = Heat-Resistant (a) = Potential Bleed / Migration (b) = ESO plasticizer (Epoxidized Soybean Oil) (c) = Pigment may fade in acidic environment LIGHTFASTNESS I = Indoor Only I/O = Indoor or Outdoor Mass = Outdoor Masstone Application Only C = Some Caution Advised HEAT STABILITY 1 = Above 400°F 2 = 350°F–400°F 3 = Below 350°F C = Some Caution Advised www.avient.com Copyright © 2020, Avient Corporation.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
https://www.avient.com/sites/default/files/2020-12/firecon-cpe-a-processing-guide.pdf
FireCon™ THERMOPLASTIC CPE-A PROCESSING GUIDE General Extrusion Guidelines FireCon™ Thermoplastic CPE-A is a flexible thermoplastic chlorinated polyethylene blend designed for industrial instrumentation, power, and control cables.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
https://www.avient.com/sites/default/files/2024-06/Cesa Flame Retardant Product Selection Guide %281%29.pdf
PE Control Conventional FR Cesa F-Series 1 Cesa F-Series 2 Time, Seconds H ea t R el ea se R at e kW /m 2 2000 1500 1000 500 0 1.844.4AVIENT www.avient.com Copyright © 2024, Avient Corporation.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment.
Some formulations are specific for use in U.S. and Canada.