https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.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 concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience 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 • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2020-09/crtm-panel-product-bulletin-2020.pdf
VALUE SOLUTION Improve quality, reduce weight and lower manufacturing costs with CRTM panels Sandwich panels manufactured with the CRTM automated pultrusion process demonstrate consistent mechanical properties with superior strength, and are well suited for a wide variety of applications. The unique manufacturing process yields uniform quality throughout the panel, ensuring complete resin impregnation, high fiber volume content, low void content, uniform thickness, and core bonding throughout. Unlimited lengths and a continuous manufacturing process also provide significant cost savings over traditional composite panel manufacturing techniques.
https://www.avient.com/sites/default/files/2021-04/onflex-s-garden-hose-hand-grip-case-study.pdf
The use of 2K (two-component) molding—in which the base resin is injected and allowed to set up for a short time, and then is overmolded by injecting the TPE—streamlines the manufacturing process. For this manufacturer, another appealing aspect of working with this material was Avient’s dedicated TPE production line in Spain, which is used solely to manufacture TPEs for overmolding applications. Lower system costs = higher margins: By reducing waste from part deformation, the Avient TPE allowed the manufacturer to leverage efficient, fast 2K molding for system cost reduction.
https://www.avient.com/sites/default/files/resources/Marine%2520Panels%2520Application%2520Bulletin.pdf
Because the manufacturing process is continuous, it also provides significant cost savings over traditional composite panel manufacturing techniques. Working together, we can help optimize your marine manufacturing system to raise throughput, increase efficiency and achieve repeatable quality.
https://www.avient.com/sites/default/files/2021-04/bergamid-seat-fastener-case-study.pdf
HellermannTyton, a global leader in designing and manufacturing fastening solutions for the automotive industry, wanted to improve upon the bent steel plate it was using to fabricate a complicated seat fastening device for a leading automotive manufacturer. The new seat securement part has already been adopted by one OEM customer, and we are confident that other manufacturers will come to us for this lightweight, cost-efficient solution.”
https://www.avient.com/sites/default/files/2021-06/fl.a4.datasheet-technora.pdf
Manufacturer Teijin™. TECHNORA® TECHNORA® DATA Standard Modulus * Equilibrium moisture regain @ 55% RH ** Creep @ 40%-58% ultimate tensile strength *** Shrinkage in dry air @ 177 C for 30 minutes LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.
https://www.avient.com/sites/default/files/2021-06/fl.us-.datasheet-vectranr-lcp.pdf
Manufacturer Kuraray™. LIQUID CRYSTAL POLYMER (LCP) LIQUID CRYSTAL POLYMER (HM) BARE FIBER PERFORMANCE * Equilibrium moisture regain @ 55% RH ** Creep @ 40%-58% ultimate tensile strength *** Shrinkage in dry air @ 177 C for 30 minutes ABOUT FIBER-LINE® LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
KEY CHARACTERISTICS • Globally harmonized formulations are manufactured at four ISO 13485 certified medical sites, providing global consistency and increased security of supply • Documented change control available • A range of standard colors eliminates color matching to expedite development time • The portfolio includes compliant colors for use in: - Needle hub applications: ISO 6009 - Ophthalmic container closures (American Academy of Ophthalmology) REGULATORY SUPPORT • A library of pre-tested raw materials including: - 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* HEALTHCARE APPLICATIONS • Medical devices such as catheters, surgical and dental instruments, and drug delivery devices • Pharmaceutical packaging including vials and bottles • Diagnostics for blood analysis or In Vitro Diagnostics (IVD) PRODUCT BULLETIN & COLOR CARD * FDA/EU compliance information available upon request; exceptions may occur Color Pantone Reference PE Base PP Base Transparent PP Base PEBA Base PC Base Transparent PC Base* ABS Base* White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 Colors may vary from actual color shown. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.
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. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, and with all applicable laws and regulations. 1.844.4AVIENT www.avient.com
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. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.