| HS Code | 250112 |
| Product Name | Evonik VESTAMID Care ML16 Medical Grade Nylon 12 |
| Density | 1.01 g/cm³ |
| Melting Temperature | 178 °C |
| Glass Transition Temperature | 40 °C |
| Tensile Modulus | 1600 MPa |
| Yield Stress | 45 MPa |
| Yield Strain | 5 % |
| Elongation At Break | >50 % |
| Flexural Modulus | 1400 MPa |
| Charpy Impact Notched | 5 kJ/m² |
| Water Absorption | 0.7 % |
| Melt Volume Rate | 8 cm³/10min at 230 °C, 5 kg |
As an accredited Evonik VESTAMID® Care ML16 Medical Grade Nylon 12 factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | VESTAMID® Care ML16 Medical Grade Nylon 12 is supplied in 25 kg moisture-protective, sealed bags ensuring purity and safe handling. |
| Container Loading (20′ FCL) | 20′ FCL loading of Evonik VESTAMID Care ML16 Medical Grade Nylon 12, palletized in sealed, moisture-protective bags for safe transport. |
| Shipping | VESTAMID® Care ML16 ships as sealed, moisture-protected bags or drums to preserve medical-grade purity. Store in a cool, dry area away from direct sunlight and heat sources. Avoid prolonged exposure to humidity; handle with clean gloves. Standard freight is suitable; protect from physical damage during transit. |
| Storage | Store VESTAMID® Care ML16 in its original, unopened packaging in a cool, dry, well-ventilated area. Keep away from direct sunlight, heat sources, and moisture. Maintain moderate temperatures and protect from contamination. Ensure containers are sealed when not in use. Avoid prolonged exposure to humidity to prevent degradation. |
| Shelf Life | Store in original sealed packaging, cool and dry. Shelf life is typically two years from date of manufacture. |
Thin-wall intravascular catheter shafts position VESTAMID® Care ML16 as the outer jacket over a lubricious liner and metallic reinforcement because the polyamide 12 backbone retains hoop strength at wall thicknesses below 0.25 mm while resisting cyclic flexural cracking. The material must be conditioned to a residual moisture content below 0.10% before melt extrusion; industrial operations achieve this with a closed-loop desiccant dryer at 80±5°C for 4–8 h and a dew point not exceeding -40°C. On a single-screw extruder with a grooved feed zone, 24:1–30:1 L/D ratio, and 3.0:1–3.5:1 compression ratio, the melt temperature at the breaker plate is held between 220°C and 245°C; excursions above 250°C thermally soften the PTFE liner and collapse the lumen during vacuum sizing, while operation below 215°C produces elevated melt pressure, surface melt fracture, and die-lip build-up. The downstream process is a two-stage jacketing line: first the stainless-steel or LCP braid layer is tension-wound over a 0.025–0.076 mm PTFE liner, then the pressure tooling applies the ML16 jacket at 0.08–0.35 mm nominal wall thickness through a laser micrometer closed-loop control at ±0.01 mm tolerance. For monolayer jackets, the compound is processed neat at 100 wt% ML16; radiopaque variants meter a PEBA-carrier barium sulfate concentrate at 15–25 wt%, and flexibility-adjusted grades blend ML16 with polyether block amide at 20–40 wt% depending on Shore D target. Compliance is documented under ISO 10555-1 for intravascular catheter shaft construction, ISO 10993-1:2018 for biological evaluation selection, ISO 10993-4:2017 for blood-contact testing, and USP <88> Class VI for systemic toxicity endpoints. Finished parts are used as outer shafts for central venous catheters, peripherally inserted central catheter lines, and diagnostic angiography guide catheters where pushability and kink resistance are load-bearing requirements.
| Process variable | Lower control limit | Upper control limit | Failure mode beyond boundary |
|---|---|---|---|
| Residual moisture before extrusion | 0.05% | 0.10% | Hydrolytic viscosity loss and surface splay above upper limit; overdrying embrittlement below lower limit |
| Melt temperature at adapter | 220°C | 245°C | Melt fracture below lower limit; liner softening and lumen collapse above upper limit |
| Jacket wall thickness | 0.08 mm | 0.35 mm | Die-lip accumulation below lower limit; void formation above upper limit |
Injection-molded luer fittings and stopcock bodies manufactured from VESTAMID® Care ML16 shift the dominant failure mode from melt fracture to solidification shrinkage and dimensional nonconformance under ISO 80369-7:2016. The material is dried to residual moisture below 0.10% using the same 80±5°C desiccant profile and processed on an injection molding machine with a 20:1–25:1 L/D screw and a check-ring non-return valve to prevent melt decompression. Melt temperature is set between 235°C and 250°C; mold wall temperature is maintained at 50–70°C with turbulent-flow water channels, because lower mold temperatures freeze the crystalline skin before pack-out and produce gate blush, while higher mold temperatures extend cycle time without measurable improvement in crystallinity. The formulation is employed neat at 100 wt% ML16; a PA12-carrier color masterbatch may be metered at 1–3 wt%, and impact-modified connector bodies incorporate polyether block amide at 8–15 wt% where drop-impact performance after steam sterilization must be preserved. Injection speed is profiled with a short initial fast filling phase at 60–90 mm/s screw velocity to penetrate the core before the gate freezes, followed by a reduced velocity at 15–25 mm/s during the packing stage; hold pressure is maintained at 60–100 MPa hydraulic-specific pressure until the gate seals. Biocompatibility evidence is anchored to ISO 10993-5:2009 for cytotoxicity, ISO 10993-10:2010 for irritation and sensitization, ISO 10993-11:2017 for systemic toxicity, and USP <88> Class VI; dimensional verification uses ISO 80369-7:2016 Annex B gauge geometries and is performed after 24 h conditioning at 23±2°C and 50±5% RH. The terminal components are Luer lock hubs, rotating male luer connectors, three-way stopcock bodies, and female luer caps used in infusion therapy and hemodynamic monitoring circuits.
In medical device packaging, VESTAMID® Care ML16 is converted as a cast barrier layer inside multilayer films for thermoformed rigid blisters and flexible pouches, where the governing standard is ISO 11607-1:2019 for sterilized device packaging. The resin is dried below 0.10% moisture and extruded at 230–250°C through a flat die onto a chill roll held at 30–60°C; the film remains amorphous enough for the subsequent thermoforming step. In a three-layer A/B/A film, ML16 constitutes 20–35 wt% of the total film mass as the core or seal layer, with polyolefin skins; monolayer cast film processed at 100 wt% ML16 is limited to thermoforming depths below 10 mm because increasing draw ratio reduces corner wall thickness below 0.05 mm. Thermoforming on a plug-assisted forming line is conducted at sheet temperatures of 130–160°C using heated plugs at 120–140°C to limit sticking; the formed cavities are then sealed to uncoated Tyvek or paper lidstock at 135–160°C. Regulatory compliance includes ISO 11607-1:2019 for seal strength and barrier integrity, ISO 10993-5:2009 for extractables-driven cytotoxicity, and ASTM F1980-21 for accelerated aging of sterile barrier systems. Terminal products include rigid blister trays for pre-filled syringes, flexible pouches for catheters, and formed packaging inserts for orthopedic implant kits.
Multi-lumen microcatheter tubing manufactured with VESTAMID® Care ML16 as the inner lumen layer is extruded through a compound die where the PA12 layer is co-extruded with a Shore-D polyether block amide outer body, and the polyamide-12 layer reduces guidewire friction without requiring a separate silicone coating. Formulation addition is specific to the inner layer only: 100 wt% ML16 in the luminal surface layer, representing 10–20% of the total wall thickness; the outer PEBA layer contains 100 wt% PEBA with a barium sulfate load of 15–25 wt% if fluoroscopic visibility is specified. The coextrusion line uses two 20:1–24:1 single-screw extruders feeding a multi-lumen crosshead with 0.2–0.5 mm individual lumen mandrels; melt temperatures are kept at 220–240°C for ML16 and 210–230°C for PEBA to maintain a viscosity ratio near 1:1 at the confluence. Vacuum sizing at -0.03 to -0.06 MPa and air-gap distance below 40 mm are maintained to prevent interlayer delamination, because air-gap stretching above 40 mm produces molecular orientation at the interface and reduces burst strength. Compliance is assessed under ISO 10555-1 for catheter tubing, ISO 10993-1:2018 for categorization, ISO 10993-18:2020 for extractables and leachables chemical characterization, and ASTM D638-14 for tensile property retention after sterilization. Terminal finished products include triple-lumen catheter inner tubes, microcatheter shafts for guidewire exchange, and multi-lumen perfusion tubing for minimally invasive delivery of contrast media.
VESTAMID® Care ML16 is used in overmolded hand grips and instrument handles where a glass-fiber-free nylon 12 surface is required for resistance to repeated steam sterilization and for low thermal conductivity during prolonged procedures. The resin is processed neat at 100 wt% ML16 in the overmolding stage; if color coding is required for instrument identification, a PA12-compatible masterbatch is added at 0.5–2 wt%, and vibration-welding or adhesive bonding is not required because the insert molding process creates mechanical locking through knurled or cross-drilled features on the stainless steel shank. Injection molding is performed with a melt temperature of 235–255°C and a mold temperature of 60–90°C to reduce differential shrinkage between the metal insert and the polymer; the insert is preheated to 80–100°C before overmolding. Clamp force must be calculated at 4–6 kN/cm² projected area, and pack pressure is held at 70–110 MPa specific pressure to prevent sink marks around the insert. Compliance for reusable surgical instruments includes ISO 17665-1:2006 for moist heat sterilization, ISO 10993-1:2018 for skin-contact biological evaluation, ISO 10993-5:2009 for cytotoxicity, and ISO 10993-10:2010 for skin irritation; mechanical performance is verified by ASTM D638-14 for tensile property retention. Terminal products include handles for laparoscopic graspers, orthopedic rasp handles, and reusable instrument grips for surgical staplers.
Competitive Evonik VESTAMID® Care ML16 Medical Grade Nylon 12 prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Evonik VESTAMID® Care ML16 Medical Grade Nylon 12 is an unfilled, plasticizer-free polyamide 12 (PA12) homopolymer formulated for medical device applications requiring low moisture uptake, ductility, and narrow melt-viscosity control during microextrusion. The ML16 designation identifies a medium-flow grade within the VESTAMID® Care portfolio; its melt volume-flow rate is reported as 16 cm³/10 min under ISO 1133-1 at 235°C and 5 kg when pellets are dried below 0.1% moisture. The PA12 repeat unit contains a longer methylene sequence than PA6 or PA66, reducing amide-group density and equilibrium moisture absorption; the dry-as-molded glass transition is near 45°C under ISO 11357-2, and the melting peak is near 178°C under ISO 11357-1/-3. This rheological profile permits thin-wall tube drawdown without external plasticizers. Typical applications include single- and multi-lumen catheter shafts, introducer tubing, luer components, and injection-molded connector housings. The material is tested for cytotoxicity according to ISO 10993-5, for irritation and delayed-type hypersensitivity according to ISO 10993-10, and for acute systemic toxicity according to ISO 10993-11, with supplier change-control documentation maintained for medical-grade continuity.
In production-scale tubing extrusion on single-screw extruders with screw diameters of 18–25 mm and 24:1 L/D, pre-drying at 80°C for 4–6 h in dehumidified air is required to keep pellet moisture below 0.10%; residual moisture above 0.15% at melt temperatures exceeding 250°C produces hydrolysis-induced splay and lumen wall defects. Three-zone screws with compression ratios of 2.5:1 to 3.0:1 are commonly used, and a Maddock mixing section improves homogenization without generating excessive shear heat. A reverse-temperature profile from hopper to die, with die temperature held between 220°C and 240°C, is used to control melt viscosity. Melt pressure at the breaker plate should remain below the screw's continuous thrust rating; for the 16 cm³/10 min MVR resin, pressure excursions above 400 bar (40 MPa) indicate insufficient melt temperature or a partially blocked screen pack. Drawdown ratios between 3:1 and 5:1 and an air gap of 5–15 cm are typical for catheter shafts with outer diameters from 1.0 mm to 3.0 mm. Batch-to-batch MVR variation of ±2 cm³/10 min can shift the stable drawdown window; lot-specific viscosity data should be used for extrusion line setup. In multi-lumen tubing, lumen concentricity is maintained by controlling melt flow balance across the tip; a melt pump after the screen changer dampens pressure pulses and improves dimensional stability.
During injection molding of connectors with wall sections between 0.5 mm and 2.0 mm, a melt temperature of 220–250°C, a mold temperature of 40–80°C, and a medium injection velocity are used to minimize gate blush and jetting. The material's low moisture absorption reduces dimensional change in humid environments; specimens conditioned at 23°C and 50% relative humidity absorb approximately 0.7% moisture under ISO 62, whereas PA66 can exceed 2.5%. This difference is relevant for click-fit luer features where post-molding expansion must remain below assembly tolerance bands. Multi-cavity runner balancing should use full rheological data rather than single-point MVR because the viscosity curve under injection shear rates is not Newtonian. For hot-runner systems, nozzle and manifold temperatures above 250°C require short residence times; prolonged hold at elevated temperature increases the risk of gate-stringing and thermal degradation.
VESTAMID® Care ML16 is unfilled and contains no glass or mineral reinforcement, so melt-processed surfaces are smoother and less abrasive than glass-filled PA12 grades used for structural hubs. Under ISO 527-1/-2, tensile modulus of typical unfilled ML16 is approximately 1500 MPa, whereas 30% glass-filled PA12 can exceed 6000 MPa; the lower modulus permits catheter shaft bending without kinking at small radii. ML16 is not a substitute for glass-filled grades in load-bearing stopcocks or high-pressure connectors because its unreinforced yield stress is approximately 46 MPa under ISO 527-1/-2, while 30% glass-filled PA12 can exceed 120 MPa tensile strength; tensile creep behavior under ISO 899-1 must also be compared. Compared with polyamide 11, ML16 has lower equilibrium water uptake and a slightly lower density near 1.01 g/cm³, which reduces weight per meter of tubing. Compared with PA6 and PA66, ML16 typically absorbs less moisture and therefore exhibits less cross-sectional swelling in high-humidity environments; chemical resistance to specific lubricants and disinfectants must be validated for the finished device. Unlike plasticized PVC, ML16 contains no ortho-phthalate plasticizers, eliminating a potential extractables class and simplifying chemical characterization under ISO 10993-18. The grade is stiffer than low-durometer polyether block amide elastomers; device designs requiring Shore D hardness below 40 may require blending with a softer copolymer. Published comparative extractables data between ML16 and glass-filled PA12 under ISO 10993-18 is limited; material-specific chemical characterization is recommended for final device submission.
Within the VESTAMID® Care portfolio, ML16 sits between lower-viscosity grades intended for high-flow micro-molded parts and higher-viscosity grades intended for large-diameter tubing or blow molding. Selection is normally made by comparing viscosity number under ISO 307, not solely MVR, because the two values respond differently to molecular-weight distribution. In thin-wall catheter shafts below 0.5 mm wall thickness, ML16 has produced fewer melt-fracture artifacts than higher-viscosity PA12 in some production trials; however published comparative data for this specific configuration is limited. Higher-viscosity grades provide greater melt strength to resist sagging in sizing tanks, while ML16 provides lower pressure drop across fine screens and multi-lumen tips.
When radiopaque filler is required for catheter stripe or marker applications, barium sulfate is commonly compounded at 20–30 wt%. The filler increases melt viscosity and can lower the thermal-oxidative stability limit; pre-compounded radiopaque grades are usually preferred over dry-color addition at the press because dispersive mixing in a single-screw extruder is limited. If a masterbatch is used, the carrier resin should be fully miscible with PA12 and the screw should include a Maddock mixing section to avoid streaking.
The following values are representative for unfilled, unlubricated ML16 in the dry-as-molded state at 23°C unless otherwise noted. They are not specification limits; the current certificate of analysis and final device testing govern release criteria.
| Property | Test method | Typical value |
|---|---|---|
| Density | ISO 1183-1 | 1.01 g/cm³ |
| Melt volume-flow rate, 235°C/5 kg | ISO 1133-1 | 16 cm³/10 min |
| Melting temperature, DSC, 10 K/min | ISO 11357-1/-3 | 176–180°C |
| Tensile modulus, 1 mm/min | ISO 527-1/-2 | 1500 MPa |
| Yield stress, 50 mm/min | ISO 527-1/-2 | 46 MPa |
| Yield strain | ISO 527-1/-2 | 5% |
| Nominal strain at break | ISO 527-1/-2 | >50% |
| Charpy notched impact strength, 23°C | ISO 179-1/1eA | 6 kJ/m² |
| Charpy notched impact strength, -30°C | ISO 179-1/1eA | 5 kJ/m² |
| Shore D hardness, 15 s | ISO 868 | 70 |
| Moisture absorption, 23°C/50% RH | ISO 62 | 0.7% |
| Moisture absorption, water saturation, 23°C | ISO 62 | 1.4% |
Properties measured on gamma-sterilized components can deviate from dry-as-molded data due to oxidation and molecular-weight changes; device-specific testing at the final sterilization dose is required. Colorants and radiopaque fillers can shift tensile modulus, notched impact strength, and melt flow.
Biocompatibility documentation for VESTAMID® Care ML16 is typically structured around ISO 10993-1 endpoints appropriate for surface- or tissue-contacting devices with limited duration, including cytotoxicity (ISO 10993-5), irritation and delayed-type hypersensitivity (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). The grade may be tested to USP <88> Class VI when a compendial test is required. Regulatory change control and absence of animal-derived components are documented by the supplier; however, final sterilization validation remains the responsibility of the device manufacturer. For ethylene oxide sterilization under ISO 11135, residual gas aeration must be verified for multi-lumen catheter shafts because PA12 can retain low concentrations of ethylene oxide in amorphous regions after short aeration cycles. Gamma sterilization at standard doses can shift color and reduce notched impact strength; devices requiring multiple sterilizations should test mechanical retention after cumulative doses. Steam autoclaving at 121°C may hydrolyze amide linkages over repeated cycles and is therefore limited to cases where molecular-weight retention is verified by ISO 307 viscosity number after the maximum number of cycles.
| Requirement | Standard or method | Typical documentation |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | L929 MEM elution |
| Irritation | ISO 10993-10 | Intracutaneous reactivity |
| Delayed-type hypersensitivity | ISO 10993-10 | Guinea pig maximization or LLNA |
| Acute systemic toxicity | ISO 10993-11 | Extract injection |
| Endotoxin | USP <85> | LAL kinetic chromogenic |
| Physicochemical characterization | ISO 10993-18 | FTIR, GC-MS, ICP-MS |
Pellets are supplied in sealed, moisture-barrier packaging and should be kept dry at ambient temperatures below 30°C. Opened containers should be re-sealed under dry nitrogen if not consumed within 24 h. Drying in dehumidified air at 80°C for 4–6 h is required before processing; vacuum drying at 80°C for 6–8 h is also used. Extended residence times above 280°C or hot-runner temperatures above 290°C promote thermo-oxidative chain scission, visible as yellowing and a fall in ISO 179-1/1eA notched impact strength. Regrind use should be controlled by process validation; melt-flow drift from repeated heat histories may narrow the processing window. Avoid contact with strong mineral acids at elevated process temperatures because the amide linkage hydrolyzes, reducing molecular weight.
