| Код ТН ВЭД | 400332 |
Как аккредитованный завод EMS-Grivory Grilamid XE 3997 nat PAMACM12, мы соблюдаем строгие протоколы качества - каждая партия подвергается строгим испытаниям для обеспечения последовательных стандартов эффективности и безопасности.
| Упаковка | Supplied as natural pellets in a sealed moisture-proof 25 kg bag. Store dry, protect from moisture, and reseal after use. |
| Погрузка контейнера (20-футовый контейнер) | 20′ FCL of EMS-Grivory Grilamid XE 3997 nat PAMACM12, packed on pallets in sealed moisture-protective packaging, loaded securely and containerized for transport. |
| Доставка | EMS-Grivory Grilamid XE 3997 nat PAMACM12 is a polyamide resin shipped as solid granules in sealed, moisture-resistant packaging. Transport is non-hazardous, but keep dry and avoid excessive heat. Standard ground or air freight is suitable; store in a cool, ventilated area away from direct sunlight. |
| Хранение | Store Grilamid XE 3997 nat in its original, sealed container in a cool, dry, well-ventilated area away from direct sunlight, heat sources, and moisture. Keep the packaging tightly closed when not in use to prevent water absorption and contamination. Avoid contact with strong oxidizers. Follow manufacturer guidelines for shelf-life management. |
| Срок годности | Store sealed in original packaging, cool and dry. Typical shelf life is two years from manufacture date. |
In transparent medical fluid-management components, the amorphous PAMACM12 backbone eliminates spherulite-induced light scattering across wall thickness changes between 1.0 mm and 3.5 mm, allowing light transmission above 92% at 2 mm when measured according to ISO 13468-2. The grade is pre-dried in a closed-loop desiccant dryer with a dew point of -40°C to a residual moisture of 0.08 wt% or lower before being melt-compounded; hopper residence above 4 h at 80°C may oxidise pellet surfaces and increase yellowness. Moulding is performed in an ISO Class 8 cleanroom with barrel settings of 230/260/275/275°C for rear, middle, front and nozzle zones, an air-shot melt temperature of 265°C to 285°C, and a polished P20 mould block held at 70°C to 90°C. Regrind from sprues and cold runners is limited to 10 wt% of the shot mass because higher fractions increase the incidence of splay and platelet surface marks in transparent walls; external release agents are excluded from the granulate recipe to preserve cytotoxicity and sensitisation results under ISO 10993-5:2009 and ISO 10993-10:2010. Typical terminals are three-way stopcock bodies, luer-activated valve housings, Y-site injection ports and transparent syringe-pump manifold shells, all of which require tapered luer surfaces conforming to ISO 80369-7:2016 and a biological evaluation plan that also includes USP <88> Class VI extraction at 121°C for 1 h. No phthalate plasticisers, halogens or bisphenol-A are added to the neat resin.
| Parameter | Set point / acceptable band |
|---|---|
| Residual moisture after desiccant drying | ≤ 0.08 wt% |
| Dew point of drying air | -40°C to -30°C |
| Barrel temperature, rear/middle/front/nozzle | 230/260/275/275°C |
| Measured melt temperature | 265°C to 285°C |
| Mould temperature, polished P20 insert | 70°C to 90°C |
| Holding pressure | 45 MPa to 70 MPa |
| Back pressure, hydraulic | 0.5 MPa to 1.5 MPa |
| Screw rotation speed | 60 rpm to 120 rpm |
| Maximum melt residence time | 8 min |
| Recommended clamp force per projected area | 0.4 kN/cm² to 0.7 kN/cm² |
In ophthalmic frame production, flow-induced birefringence in rim fronts with a wall thickness of 2.0 mm to 4.0 mm responds more strongly to mould wall temperature than to holding pressure alone, because the amorphous PAMACM12 matrix retains frozen-in chain orientation when the cavity surface is below the effective glass-transition band. A mould temperature of 70°C to 90°C combined with a holding pressure of 45 MPa to 70 MPa produces a uniform stress-optical signature under polarised light; dropping the mould temperature to 60°C while raising holding pressure to 95 MPa does not compensate for rapid skin solidification and may increase gate blush around a 0.8 mm pin-point gate. Transparent tinted formulations are prepared with soluble organic dyes at 0.05 wt% to 0.2 wt% pre-dispersed in the same PAMACM12 carrier; pigment-based masterbatches above 1.0 wt% raise haze beyond 1.5% at 2 mm under ASTM D1003. The injection screw should have an L/D of 20:1 to 25:1 and a shallow compression zone to limit shear heating; screw surface temperature is monitored by infrared pyrometer to stay below 285°C. Finished frame fronts and temples are conditioned at 23°C and 50% RH for 24 h before dimensional audit to ISO 12870:2016, where nose pad clamping strength and temple retention must be validated on the fully assembled frame rather than on the raw moulding.
At a 25 kGy gamma irradiation dose validated under ISO 11137-2:2013, transparent PAMACM12 pump-housing windows exhibit measurable yellowing when oxygen ingress and internal free radicals are not controlled by barrier packaging and post-irradiation annealing. The recommended logistics chain specifies double-sealed aluminium foil-laminate pouches with an oxygen scavenger and a desiccant, filled under nitrogen; pre-irradiation thermal conditioning at 60°C for 4 h in the sealed pouch reduces b-value increase by helping recombine short-lived radiolysis products, but exact b-value shift for Grilamid XE 3997 nat at 25 kGy must be established on the device master file because published multi-dose data for this specific natural grade are limited. Terminal components are insulin pump display windows, wearable injector housing covers, infusion pump cassette latching arms and optical fluid-detection lenses. After gamma treatment, tensile yield stress and elongation at break are re-tested to ISO 527-2 with Type 1A specimens at 50 mm/min; a reduction in elongation at break greater than 15% relative to unirradiated controls triggers a packaging revision. When ethylene oxide is selected as an alternative sterilisation route, residual ethylene oxide and ethylene chlorohydrin must meet limits specified in ISO 10993-7:2008, and forced-air aeration at 50°C to 55°C for 12 h is typically used to reduce residuals.
Pneumatic filter-regulator-lubricator bowl replacement becomes technically unavoidable when polycarbonate bowls show environmental stress cracking caused by isopropanol wipedown combined with compressor oil carryover at temperatures above 50°C. Injection-moulded PAMACM12 bowls withstand brief exposure to aliphatic compressor oil aerosols and 2 wt% to 10 wt% isopropanol/water cleaning solutions with markedly lower cracking tendency; the part is qualified by immersion testing in ISO 175 for 72 h at 60°C in a synthetic compressor oil/water emulsion containing 2 wt% isopropanol. The bowl is injection-moulded from natural tube stock with a wall thickness of 2.5 mm to 5.0 mm, polished core and cavity inserts at 70°C mould temperature, and an internal weld line shifted to the bowl base by a ring gate. Service boundaries must be verified against the equipment manufacturer's pressure-cycling requirements; continuous operation at 8 bar to 10 bar supply pressure and 40°C to 60°C bowl temperature is common in industrial compressed-air preparation units, but UV exposure, ozone and de-icing additives require paired gasket validation. Terminal assemblies include transparent bowls for FRL units, oil-mist separator housings and inspection windows on coalescing filters installed downstream of screw compressors.
Diesel low-pressure fuel system sight glasses are produced as 5 mm-thick transparent discs insert-moulded into glass-fibre-reinforced polyamide filter heads. The PAMACM12 disc provides visual confirmation of water accumulation in the lower bowl without requiring fuel-circuit depressurisation. Screening in biodiesel-containing diesel blends is carried out to SAE J1645 style fuel immersion; for MACM12-based transparent polyamide, industrial exposure data show weight change below 3% after 30 days at 60°C in a B7 diesel/water two-phase mixture, while grade-specific data for Grilamid XE 3997 nat in B100 are limited and require separate assessment because fatty acid methyl esters swell amorphous polyamide over extended exposure. The disc is gated at a trapezoidal edge gate of 1.0 mm thickness and 4.0 mm width; the mould runs an oil-heated insert at 80°C, and a clamp force of 1,200 kN is adequate for a single-cavity tool with projected shot area 45 cm². After demoulding, the disc is annealed in an oil bath at 80°C for 3 h under nitrogen to relax machine-direction orientation. Terminal products are water-in-diesel sensor inspection windows, lift-pump bypass indicators, and low-pressure fuel filter cartridge status lenses.
Chromatography-grade demineralised water at 85°C is sufficiently aggressive to hydrolyse short-chain semi-crystalline polyamides, but the C12 dodecanedioic acid segment in PAMACM12 reduces water uptake and hydrolytic chain scission. Conductivity sensor bypass loops use extruded PAMACM12 transparent tube with an internal diameter of 20 mm and wall thickness of 3.0 mm, joined by thermal butt fusion or flared unions. Long-term service at 85°C and 0.2 MPa internal pressure is validated by immersion in demineralised water to ISO 175:2010 with tensile tracking to ISO 527-2; acceptance criteria require the tensile strain at break to remain above 80% of the original value after 500 h for general industrial use, while continuous service above 90°C is not recommended because the amorphous phase loses dimensional stability under load. The extrusion line uses a grooved-barrel single-screw extruder with L/D 30:1, a screen pack of 60/100/60 mesh, and a vacuum vent of -0.09 MPa to remove residual moisture during direct extrusion. Terminal outputs include pH analyser isolation chambers, conductivity cell sight tubes, and transparent segments on cooling water additives dosing lines. Strong mineral acids below pH 3 and primary amine-based water-treatment additives above 1.0 wt% must be avoided because they degrade the amide linkage or precipitate surface haze.
Short-term beverage dispenser components benefit from the absence of tributyl citrate plasticisers and bisphenol-A in natural PAMACM12, but regulatory approval for food-contact use must be established on the exact grade through migration testing rather than transferred from generic polyamide approvals. Injection-moulded sight-window retainers and valve plugs are tested to EU Regulation 10/2011 with food simulants A, B and D2 for overall migration and specific migration of 1,6-diamino-2,2,4-trimethylhexane if applicable, using the standard time-temperature protocols for repeated-use articles. For a 70°C hot-water contact of 2 h, the overall migration limit is 10 mg/dm²; for longer hot-fill cycles above 70°C, creep modulus under load must be rechecked because the amorphous PAMACM12 matrix softens progressively. The moulded components are pre-dried to 0.06 wt% residual moisture and run in an all-stainless-steel screw and barrel to eliminate iron oxide specks in transparent parts. Terminal products are beverage dispenser water-line inspection windows, coffee machine flow-indicator bodies, and dairy sampling valve sight glass retainers. No statement of FDA 21 CFR 177.1500 compliance is made automatically; the distributor should supply a food-contact declaration covering the exact natural grade and lot.
| Standard / regulation | Method or clause | Application boundary |
|---|---|---|
| ISO 10993-5:2009 | Biological evaluation — cytotoxicity | Medical connectors, pump housings |
| ISO 10993-10:2010 | Skin sensitisation and irritation | Wearable device housings, spectacle frames |
| ISO 10993-7:2008 | Ethylene oxide residuals | EtO-sterilised pump cassettes |
| ISO 11137-2:2013 | Radiation sterilisation dose | Gamma-sterilised transparent windows |
| ISO 80369-7:2016 | Luer conical fittings | Three-way stopcocks, manifolds |
| ISO 12870:2016 | Spectacle frame mechanical requirements | Ophthalmic frame fronts and temples |
| ISO 13468-2 | Total luminous transmittance | Transparent optical covers |
| ASTM D1003 | Haze and luminous transmittance | Spectacle components, medical windows |
| ISO 175:2010 | Chemical immersion test | Fuel, compressed-air, water-treatment contact |
| ISO 527-2 | Tensile properties | Load-bearing transparent components |
| ISO 179-1/1eA | Charpy impact, notched | Medical and automotive snap-fits |
| EU Regulation 10/2011 | Food-contact migration testing | Beverage dispenser components |
| FDA 21 CFR 177.1500 | Polyamide resin food-contact article | To be confirmed for exact grade and lot |
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EMS-Grivory Grilamid XE 3997 nat is an unreinforced, natural-colour, amorphous polyamide moulding compound based on PAMACM12. The polyamide backbone is formed from bis(4-amino-3-methylcyclohexyl)methane and dodecanedioic acid, yielding a transparent cycloaliphatic polyamide with no significant crystalline melting point. The grade is supplied as a neat, unpigmented resin intended for injection moulding of thin-wall technical, optical, medical, and pharmaceutical contact components. The designation “nat” identifies the natural colour state and is not itself a compliance statement. Representative physical data place the density at 1.01 g/cm³ when measured according to ISO 1183-1, a glass transition temperature of approximately 152 °C under ISO 11357-2, and a melt volume-flow rate of 12 cm³/10 min at 275 °C/5 kg according to ISO 1133-1. The dry-as-moulded tensile modulus is approximately 2200 MPa and the conditioned tensile modulus is approximately 1900 MPa under ISO 527-1/-2.
The amorphous morphology gives the product an optical clarity that semi-crystalline polyamides cannot provide. In processed parts, the absence of spherulitic scattering centres produces low haze and high transmitted-light clarity across wall sections typical of diagnostic housings, fluid-handling manifolds, and pump bodies. The material also has lower mould shrinkage anisotropy than many semi-crystalline grades. Representative shrinkage values fall near 0.8 % longitudinal and 0.9 % transverse under ISO 294-4, which supports predictable tool compensation in multi-cavity moulds. The moisture uptake is moderate for a polyamide: approximately 1.1 % at 23 °C/50 % RH and 3.5 % at saturation in water under ISO 62. These values are lower than those of unreinforced PA6 or PA66, which typically absorb 8.5–9.5 % water at saturation, and the stiffness shift from dry to conditioned states is correspondingly smaller.
The substituted cyclohexane rings in the MACM diamine disrupt chain packing sufficiently to suppress crystallisation during melt cooling. Under ISO 11357-3, the material does not display a conventional semi-crystalline melting endotherm. The amorphous structure allows light transmission through unoriented and moderately oriented wall sections without the opacification that occurs when spherulites form in PA6 or PA66. This structural difference also changes the mechanical and thermal response under load. The glass transition temperature of around 152 °C produces a heat deflection temperature under 1.80 MPa of approximately 125 °C by ISO 75-1/-2, with a 0.45 MPa HDT/B value near 140 °C and a Vicat B50 softening temperature near 145 °C under ISO 306. These thermal benchmarks are higher than those of typical aliphatic PA12 and PA6 but lower than the deflection temperature of semi-crystalline PA66 under high load. The polymer therefore tolerates short hot-water or steam exposure, but it is not a replacement for high-heat semi-aromatic polyamides or PEEK in continuous high-load thermal environments.
Mechanically, the grade offers a ductile failure mode. Notched Charpy impact strength is reported at approximately 8 kJ/m² dry and 9 kJ/m² conditioned according to ISO 179-1/1eA. The yield stress is approximately 80 MPa dry and 70 MPa conditioned under ISO 527-1/-2, while elongation at yield is near 7 % dry and 8 % conditioned. These values are lower than those of impact-modified polycarbonate and higher than those of unmodified PMMA. The combination of moderate stiffness, high optical clarity, and resistance to aliphatic hydrocarbon and alcohol contact makes the material suitable for transparent covers, flow meters, filter housings, and diagnostic components.
Before injection moulding, the resin must be dried to a residual moisture content below 0.10 %, with moisture level confirmed by Karl Fischer titration according to ISO 15512. Drying in a desiccant-bed or vacuum dryer at 80 °C for 4–8 h is typical. Open hopper exposure at 60 % RH can restore enough surface moisture within 30 min to generate splay and silver streaking on 1.2 mm wall sections. In production-scale moulding of transparent components, silver streak is a common failure mode when the dryer dew point drifts above -20 °C, because dissolved water expands at the flow front and leaves visible surface defects. The material should be processed with a protective nitrogen or dry-air blanket when ambient humidity exceeds 60 % RH.
Melt temperature measured at the nozzle should be maintained between 250 °C and 280 °C, with the maximum recommended melt temperature near 300 °C. Above that threshold, thermal degradation of the polyamide chain can produce yellowing and reduced melt viscosity. At 270 °C, residence time should not exceed 5 min, especially in hot-runner systems with dead spots or heated sprue bushings. A low- to medium-shear screw with L/D between 18 and 22 and compression ratio from 1.5 to 2.0 is preferred. High-compression screws designed for semi-crystalline PA66 can generate excessive shear heating and cause local overheating of the amorphous melt. Injection units should be sized so the shot volume occupies 30–70 % of barrel capacity to avoid excessive residence time and melt inventory.
Mould temperature is a critical variable for optical parts. The preferred range is 40–80 °C, with 50–60 °C commonly selected for thin-wall diagnostic housings. Uniform mould cooling is necessary because asymmetric temperature fields create orientation gradients and visible birefringence. In multi-cavity tools, cavity-to-cavity melt-filling imbalance can shift shrinkage and create part-to-part variation in transmitted-light clarity. Gates should be positioned to avoid jetting, particularly in transparent parts with polished surfaces. A valve-gate hot runner may be used only if it is naturally balanced and free of stagnation zones; otherwise, cold sprue or edge gates with open nozzles reduce yellowing risk. Production experience with natural transparent polyamide shows that oversized hot-runner manifolds and long heated drops can generate discolouration before any mechanical property loss is measurable.
| Property | Standard | Value |
|---|---|---|
| Density | ISO 1183-1 | 1.01 g/cm³ |
| Glass transition temperature | ISO 11357-2 | 152 °C |
| HDT/A, 1.80 MPa | ISO 75-1/-2 | 125 °C |
| HDT/B, 0.45 MPa | ISO 75-1/-2 | 140 °C |
| Vicat softening temperature, B50 | ISO 306 | 145 °C |
| Tensile modulus, dry / conditioned | ISO 527-1/-2 | 2200 / 1900 MPa |
| Yield stress, dry / conditioned | ISO 527-1/-2 | 80 / 70 MPa |
| Yield strain, dry / conditioned | ISO 527-1/-2 | 7 / 8 % |
| Charpy notched impact, dry / conditioned | ISO 179-1/1eA | 8 / 9 kJ/m² |
| Water absorption, 23°C/50% RH / saturation | ISO 62 | 1.1 / 3.5 % |
| Mould shrinkage, longitudinal / transverse | ISO 294-4 | 0.8 / 0.9 % |
| Melt volume-flow rate, 275°C/5 kg | ISO 1133-1 | 12 cm³/10 min |
Moisture-conditioned values refer to specimens conditioned according to ISO 1110. The shift from dry to conditioned modulus reflects plasticisation of the amide network by absorbed water. In service, components that operate in humid environments or intermittent water contact should be evaluated with conditioned values rather than dry-as-moulded data. Dimensional change from water uptake is lower than for PA6 and PA66 but is not zero, and press-fit or snap-fit designs must tolerate small swelling or stress relaxation in water-rich environments.
The grade differs from unreinforced PA6 and PA66 in transparency, moisture uptake, and mould shrinkage behaviour. PA6 and PA66 are semi-crystalline and opaque to translucent, with higher water absorption and greater stiffness loss after conditioning. The amorphous character of PAMACM12 also avoids the pronounced post-shrinkage and anisotropy that can occur in semi-crystalline polyamides. Compared with polycarbonate, the product has lower density, better resistance to stress cracking in many alcohol-based disinfectant and aliphatic hydrocarbon environments, and lower notched impact strength. Polycarbonate remains superior for very high impact applications, but its density near 1.20 g/cm³ is approximately 16 % higher than that of XE 3997 nat. Compared with PMMA, the polyamide has markedly higher ductility and chemical resistance, but PMMA offers higher surface hardness and lower moisture uptake.
Relative to PA12, which is also low-density and low-water-absorbing, the present grade is amorphous and transparent, whereas PA12 is semi-crystalline and generally translucent to opaque. PA12 has a lower glass transition temperature and softens at lower service temperatures, while PAMACM12 retains rigidity to higher temperature because of its cycloaliphatic diamine structure. Relative to other EMS transparent polyamides, XE 3997 nat is positioned as a regulated-documentation natural grade with controlled consistency for medical and pharmaceutical converters. Direct substitution between transparent polyamide grades without revalidation is not recommended because additive packages, MVR, and lot-specific compliance statements may differ.
| Material | Density, g/cm³ | Water saturation, % | Thermal benchmark |
|---|---|---|---|
| Grilamid XE 3997 nat | 1.01 | 3.5 | Tg 152 °C |
| Unreinforced PA6 | 1.14 | 9.5 | Tg ~ 60 °C / Tm 220 °C |
| Unreinforced PA66 | 1.14 | 8.5 | Tg ~ 70 °C / Tm 260 °C |
| PA12 | 1.01 | 1.5 | Tg ~ 45 °C / Tm 178 °C |
| Polycarbonate | 1.20 | 0.35 | Tg ~ 145 °C |
| PMMA | 1.19 | 1.9 | Tg ~ 105 °C |
The comparative values are rounded typical industrial data and are not a substitute for testing on the final component. In particular, water saturation values depend on specimen thickness and conditioning protocol under ISO 62. Published data for highly specific end-use configurations of this grade may be limited, and the supplier should be asked for lot-specific certificates before design freeze.
Chemical-contact behaviour is generally assessed by ISO 175 or ISO 22088 for environmental stress cracking. The polyamide is resistant to many aliphatic hydrocarbons, oils, greases, dilute acids, and alkaline solutions at ambient temperature. It is not recommended for continuous contact with strong oxidising acids, phenols, concentrated formic acid, or chlorinated solvents at elevated temperature because such media can attack the amide linkage or swell the amorphous phase. Alcohol-based disinfectants that are known to stress-crack polycarbonate are less aggressive to this cycloaliphatic polyamide, but the claim must be validated on the final stressed geometry because gate areas, weld lines, and injection-moulded residual stress can concentrate attack.
Steam autoclaving at 121 °C for 20 min approaches the HDT/A of 125 °C. Unstressed parts generally tolerate this cycle, but parts under continuous load or snap-fit deflection may relax because the polymer is near its glass transition. Gamma irradiation at common sterilisation doses may cause slight discolouration, and published data for this specific grade after gamma exposure are limited. For applications requiring post-regulatory assembly, biocompatibility must be evaluated on the final device according to ISO 10993-1. The base polymer may have supplier declarations relevant to food contact or pharmaceutical use, but final-article compliance with EU 10/2011, FDA 21 CFR 177.1500, USP Class VI, RoHS 2011/65/EU, and REACH 1907/2006/EC requires customer-specific verification because colourants, processing aids, and production residues influence the final regulatory status.
The material is unsuitable for continuous load-bearing service above approximately 125 °C under 1.80 MPa because distortion becomes significant. In transparent optical parts with polished surfaces, abrasive contact and aggressive cleaning agents should be screened because polyamide surfaces are softer than PMMA or glass and can show micro-scratching that reduces clarity. Dry-air or vacuum drying, controlled melt residence time, balanced filling, and validation of conditioned mechanical properties are the principal engineering controls for this product.