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.
Reduction in yellowing using Color Compensation Technology (CCT) Reduced material consumption/cycle time/improved properties—nucleation Fast acting new generation nucleant for PE and PP; improved dimensional stability, thermal and mechanical properties Laser marking replacing ink printing/labels Solvent-free, high-speed identification for Nd/YAG laser Antiblock for PE/PP film Non-migrating additive system maintaining high gloss and printability Antioxidants for PE, PP, TPE Thermal protection during converting/ downstream sterilization Brand protection/ anticounterfeit Range of covert and non-covert systems Volatiles/odor absorber for PE/PP Physical absorption of a wide range of molecules responsible for odor, VOC and potential extractables/ leachables in plastics Healthcare use limitations apply—see below.
https://www.avient.com/industries/healthcare/labware-diagnostics/ivd-devices
Functional additives to provide features such as low friction, UV protection, solvent-free laser markings and component assembly welding
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Additionally, plastic prefilled syringes can be color-coded for easy identification and customized to meet specific opacities in polypropylene (PP) resin, while laser marking additives can help create precise, solvent-free markings.
https://www.avient.com/sites/default/files/2020-09/surround-processing-guide-2020.pdf
TEMPERATURE Material Rear °F (°C) Center °F (°C) Front °F (°C) Nozzle °F (°C) Melt °F (°C) Mold °F (°C) Nylon 6,6 14% NiCF 540–570 (280–300) 530–560 (275–290) 530–560 (275–290) 540–570 (280–300) 540–570 (280–300) 200–300 (90–150) Nylon 6,6 30% SS 540–570 (280–300) 530–560 (275–290) 530–560 (275–290) 540–570 (280–300) 540–570 (280–300) 200–300 (90–150) PBT 14% NiCF 510–410 (265–280) 490–540 (255–280) 480–530 (250–275) 480–530 (250–275) 480–530 (250–275) 150–250 (65–120) PC 14% NiCF 540–570 (280–300) 540–570 (280–300) 530–560 (275–290) 530–560 (275–290) 530–560 (275–290) 150–250 (65–120) ABS 14% NiCF 470–520 (240–270) 460–520 (240–270) 460–520 (240–270) 460–530 (240–275) 460–530 (240–275) 100–200 (40–90) PP 14% NiCF 440–480 (225–250) 440–480 (225–250) 430–470 (220–245) 420–460 (215–240) 420–460 (215–240) 125–175 (50–80) DRYING Material Temperature °F (°C) Time Minimum Moisture Maximum Moisture Nylon 6,6 14% NiCF 180 (80) 4–5 hours 0.05% 0.20% Nylon 6,6 30% SS 180 (80) 4–5 hours 0.05% 0.20% PBT 14% NiCF 250 (120) 6-8 hours 0.02% 0.03% PC 14% NiCF 250 (120) 3–4 hours 0.02% 0.02% ABS 14% NiCF 200 (90) 2–4 hours 0.05% 0.10% PP 14% NiCF 180 (80) 2–4 hours 0.20% 0.30% Equipment • Feed throats smaller than 2.5" may cause bridging due to pellet size - Larger feed throats will be more advantageous with long fiber EMI shielding resins • General purpose metering screw is recommended - Mixing/barrier screws are not recommended • L/D ratio - 18:1–20:1 (40% feed, 40% transition, 20% metering) • Low compression ratio - 2:1–3:1 • Deep flights recommended - Metering zone 3.5 mm - Feed zone 7.5 mm • Check ring - Three-piece, free-flowing check ring • General purpose nozzle (large nozzle tips are recommended) - Minimum orifice diameter of 7/32" - Tapered nozzles are not recommended for long fiber EMI shielding resins • Clamp tonnage: - 2.5–5 tons/in2 Gates • Large, free-flow gating recommended - 0.25" x 0.125" land length - 0.5" gate depth Runners • Full round gate design • No sharp corners • Minimum of 0.25" diameter • Hot runners can be used PROCESSING Screw Speed Slower screw speeds are recommended to protect fiber length Back Pressure Lower back pressure is recommended to protect fiber length Pack Pressure 60–80% of max injection pressure Hold Pressure 40–60% of max injection pressure Cool Time 10–30 seconds (depends on part geometry and dimensional stability) PROCESS CONSIDERATIONS Recommended – retain fiber length (maximize conductivity) • Low shear process • Low screw speed and screw RPM • Slow Injection speed • Fill to 99–100% on first stage of injection - Reduces potential nesting of fibers at gate location - Improves mechanical performance near gate location - Promotes ideal fiber orientation Resin Rich Surface • Achieved when using a hot mold temperature and longer cure times ≥ Max mold temperature recommendation • Improved surface aesthetic • Reduced surface conductivity • Could reduce attenuation performance in an assembly Fiber Rich Surface • Achieved when using a cold mold temperature and shorter cure times ≤ Minimum mold temperature recommendation • Improved surface aesthetic • Reduced surface conductivity • Could improve attenuation performance in an assembly www.avient.com Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
When a chemical stress cracking agent diffuses into a polymer network it can increase the chain mobility and free volume of the system.
MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.
https://www.avient.com/resource-center/knowledge-base/article/overmolding-guide?ind%5B0%5D=6599
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https://www.avient.com/resource-center/knowledge-base/article/overmolding-guide?pname%5B0%5D=91
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https://www.avient.com/resource-center/knowledge-base/article/overmolding-guide?rtype%5B0%5D=1164
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https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues-0?rtype%5B0%5D=1164
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https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues-0?ind%5B0%5D=6595
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