| HS Code | 158676 |
| Product Name | RTP 2099 X 126217 Z |
| Material Type | Impact Modified Bio-Based Polylactic Acid (PLA) |
| Impact Modification | Yes |
| Fda Compliance | Yes |
| Bio Based Content | ≥ 90% |
| Density | 1.24 g/cm³ |
| Melt Flow Rate | 10 g/10 min (190°C/2.16 kg) |
| Tensile Strength | 38 MPa |
| Tensile Elongation At Break | 10% |
| Flexural Modulus | 2.4 GPa |
| Flexural Strength | 62 MPa |
| Notched Izod Impact | 53 J/m |
| Unnotched Izod Impact | No Break |
| Heat Deflection Temperature At 0 45 Mpa | 55°C |
| Heat Deflection Temperature At 1 8 Mpa | 49°C |
| Vicat Softening Temperature | 60°C |
| Processing Method | Injection Molding |
| Drying Temperature | 80°C |
| Drying Time | 2-4 h |
| Melt Temperature | 190-220°C |
| Mold Temperature | 25-60°C |
| Color | Natural |
As an accredited RTP 2099 X 126217 Z Impact Modified FDA Compliant Bio-Based Polylactic Acid factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | RTP 2099 X 126217 Z is supplied in 25 kg sealed, moisture-resistant bags, palletized and stretch-wrapped for safe storage and transport. |
| Container Loading (20′ FCL) | 20′ FCL loading of RTP 2099 X 126217 Z Impact Modified FDA Compliant Bio-Based Polylactic Acid; palletized, shrink-wrapped, secured for export. |
| Shipping | RTP 2099 X 126217 Z is shipped as non-hazardous, bio-based PLA resin pellets in moisture-barrier lined bags, boxes, or supersacks. Transport at ambient temperature in clean, dry vehicles. Keep sealed, avoiding heat, moisture, and contamination. Not DOT/IMDG regulated; SDS and packing list accompany shipment. |
| Storage | Store RTP 2099 X 126217 Z Impact Modified FDA Compliant Bio-Based Polylactic Acid in a cool, dry, well-ventilated area. Keep containers tightly closed, away from moisture, direct sunlight, heat, and ignition sources. Segregate from strong oxidizers, acids, and bases. Avoid dust. Do not store near food or drink. Maintain labeled containers and follow the manufacturer’s SDS and local regulations. |
| Shelf Life | Shelf life: approximately 12–24 months if kept unopened in original packaging, cool, dry, away from moisture, heat, sunlight. |
Rigid sheet extrusion followed by plug-assisted thermoforming is one of the few downstream routes where the rheological demand for sag resistance and the mechanical demand for hinge-fold durability intersect on the same production line. On sheet lines running 500–700 kg/h, the impact-modified PLA is pre-dried in desiccant dryers at 80°C for 4 h to a residual moisture content below 0.010% (100 ppm) because hydrolysis at melt temperatures above 190°C reduces molecular weight and produces surface splay on polished rolls. The governing food-contact documentation for this application includes FDA Food Contact Notification FCN 178 for polylactic acid, Commission Regulation (EU) No 10/2011 as amended with an overall migration limit of 10 mg/dm², EN 13432:2000 for industrial compostability, and ASTM D6866-21 Method B for bio-based carbon verification. Sheet extrusion is performed on a single-screw extruder with an L/D ratio of 30:1, a barrier screw equipped with a melt pump, flat die temperature 200–210°C, and roll stack temperatures 35–50°C; the sheet gauge is controlled between 0.30 mm and 0.60 mm with transverse gauge variation below ±0.02 mm. The compound is fed at 100% pelleted material, with clean post-industrial regrind limited to 25 wt% of the total melt stream because recycled PLA reduces extensional viscosity and promotes sagging in the thermoforming oven. If a processor blends with unmodified PLA for cost reduction, the impact-modified compound should remain at or above 70 wt% to keep clamshell hinge impact above 40 J/m when measured per ASTM D256-10. The thermoforming step requires sheet surface temperature held at 70–80°C, below the cold-crystallization onset of 95–105°C, and plug temperature maintained at 70–90°C with a low-thermal-conductivity plug material to reduce sticking. Terminal product types include hinged clamshells for refrigerated deli items, fruit punnets, sushi trays, and refrigerated prepared meal bases; draw ratios are kept below 3:1 on multi-cavity rotary tools unless assisted pre-stretch from plug geometry is validated. The impact-modified formulation raises notched Izod impact relative to unmodified PLA from approximately 16 J/m to 40–80 J/m, which is the principal mechanical advantage for clamshell hinges and tray corners at refrigerated temperatures.
Because impact-modified PLA has low melt strength relative to PET, the injection blow moulding route is constrained by the preform reheat window rather than by injection pressure alone. Preforms are injection moulded from 100% compound on a two-stage injection blow moulding system; qualified regrind from rejected preforms may be incorporated at up to 15 wt% only if the regrind was not exposed to moisture above 0.025% (250 ppm) before re-drying. Melt temperature at the preform injection nozzle is controlled at 200–220°C, the hot runner manifold at 210°C, and the preform mould is chilled to 10–15°C to reduce spherulite formation; injection pressures of 800–1,200 bar are typical for 24–48 cavity preform tools. Reheat is performed in infrared ovens with quartz lamps tuned to 3.0–4.5 µm wavelengths, and surface temperature is held at 85–95°C because a ±5°C deviation measurably shifts the blow-up ratio and sidewall thickness distribution by more than 20%. Blow moulding is completed at 10–12 bar into chilled moulds at 35–40°C. Compliance for food-contact bottles includes FDA Food Contact Notification FCN 178, Commission Regulation (EU) No 10/2011 as amended, and the overall migration limit of 10 mg/dm²; mechanical evaluation includes ASTM D638-14 for tensile yield, ASTM D256-10 for notched Izod impact at 4°C, and ISO 8295 for coefficient of friction on sidewalls. Terminal product types are 250–500 mL single-serve cold-chain juice and dairy beverage bottles filled below 4°C; carbonation is limited to below 2.0 volumes because PLA permeation and creep under pressure are unsuitable for high-carbonation soft drinks. Published data for this exact RTP grade in injection blow moulding is limited, so preform reheating parameters must be verified against the lot certificate and mold-flow simulation using rheological data generated per ISO 1133-1:2022 at 210°C/2.16 kg.
Injection-moulded disposable cutlery produced from this compound runs on high-speed cells with 180–250 t clamp force and 32–64 cavity hot-runner tools. The material is processed at 100% pellet feed; if a cost-reduction blend with unmodified PLA regrind is used in the same melt stream, the regrind fraction is limited to 20 wt% because higher fractions reduce spoon bowl stiffness and fork tine fracture resistance when tested per ASTM D790-17. Colour masterbatch or processing aid addition is kept at 1–2 wt% and the carrier resin must be PLA-based to preserve EN 13432:2000 compostability. Melt temperature is maintained at 190–210°C, mould temperature 25–40°C, injection speed 150–250 mm/s, holding pressure 600–1,000 bar, back pressure 5–10 bar, and cooling time 10–18 s depending on wall thickness. The compliance file includes FDA Food Contact Notification FCN 178, Commission Regulation (EU) No 10/2011 as amended, EN 13432:2000, and ASTM D6866-21 Method B for bio-based carbon content. Terminal finished product types are 4–6 g forks, spoons, knives, and sporks for cold and warm foodservice up to 80°C, with the caveat that exposure to boiling water or microwaves is outside the operational boundary because heat deflection temperature under 0.455 MPa is typically 52–58°C per ASTM D648-18. The impact-modified grade is selected over conventional PLA because cutlery under bending load at tine roots shows improved resistance to crack initiation; notched Izod values are typically 40–80 J/m per ASTM D256-10, while flexural modulus remains in the 2.5–3.5 GPa range.
Rollstock extrusion of impact-modified PLA for foodservice cup lids uses a flat die at 800–1,200 mm effective width with die gap set to 0.5 mm and air knife polishing rolls at 40–55°C. The compound is run at 100% pellets, with edge trim and reject rollstock reintroduced at a maximum of 20 wt% through a closed-loop granulator and desiccant re-dryer because moisture uptake above 0.010% (100 ppm) reduces heat-seal strength and produces die-lip buildup. Addition of antiblock masterbatch is limited to 1–2 wt% using a PLA carrier; the masterbatch must carry the same FDA Food Contact Notification FCN 178 and Commission Regulation (EU) No 10/2011 migration documentation. Sheet thickness is controlled between 0.20 mm and 0.40 mm, and post-extrusion corona treatment is set to 38–42 dyn/cm for printing and heat-seal lacquers. Compliance for this application includes FDA Food Contact Notification FCN 178, Commission Regulation (EU) No 10/2011 as amended, EN 13432:2000, and ASTM F88/F88M-21 for seal strength on finished lidding pairs. The downstream process consists of in-line thermoforming of lid skirts and scoring; punch-and-die sets are heated to 60–70°C to prevent micro-cracking at score lines. Terminal product types are 80 mm and 95 mm rigid cup lids for PLA-lined cold beverage cups, portion cup lids for dairy desserts, and tamper-evident dairy sleeve lids. The operational boundary is cold-chain use; exposure above 55°C under load causes creep and lid doming.
| Application scenario | Food-contact compliance | Compostability / bio-based verification | Mechanical or analytical test designations |
|---|---|---|---|
| Thermoformed refrigerated trays and clamshells | FCN 178, (EU) No 10/2011 | EN 13432:2000, ASTM D6866-21 Method B | ASTM D256-10, ASTM D638-14 |
| Injection blow-moulded cold-chain bottles | FCN 178, (EU) No 10/2011 | EN 13432:2000 | ASTM D638-14, ASTM D256-10, ISO 1133-1:2022, ISO 8295 |
| Injection-moulded disposable cutlery | FCN 178, (EU) No 10/2011 | EN 13432:2000, ASTM D6866-21 Method B | ASTM D790-17, ASTM D648-18 |
| Extruded rollstock cup lids | FCN 178, (EU) No 10/2011 | EN 13432:2000 | ASTM F88/F88M-21 |
| Single-serve capsule bodies and lidding rings | FCN 178, (EU) No 10/2011 | EN 13432:2000 | ASTM D1238-20, ISO 1133-1:2022 |
| Extrusion blow-moulded dry-food jars | FCN 178, (EU) No 10/2011 | EN 13432:2000 | ASTM D638-14, ASTM D256-10 |
Single-serve coffee capsule bodies and lids manufactured from impact-modified PLA are moulded in 16–32 cavity hot-runner tools with wall thicknesses of 0.4–0.8 mm. The material is processed at 100% pellets; hot-runner purgings and short shots are re-introduced as regrind at up to 15 wt% only after sorting to eliminate charred resin and moisture exposure above 0.015% (150 ppm). Melt temperature is set at 210–230°C, mould temperature 30–45°C, injection pressure 1,000–1,500 bar, holding pressure 600–900 bar, and cooling time 6–10 s. The gate must freeze before holding pressure is released; otherwise, voids occur at the capsule rim seal, reducing burst resistance. Compliance documentation includes FDA Food Contact Notification FCN 178, Commission Regulation (EU) No 10/2011 as amended, EN 13432:2000 for compostable capsule systems, and ASTM D1238-20 for melt flow rate measured at 210°C/2.16 kg. Terminal product types are 5–7 g coffee capsule bodies and lidding rings for compostable pod systems; brewing temperatures of 85–95°C are tolerated only for short contact times because the PLA compound softens above 55°C. The application is structurally feasible only when the capsule body is supported by an outer shell or brew chamber; published data for this specific RTP grade in capsule geometry is limited, so mold-flow analysis must be calibrated against capillary rheometry data rather than generic PLA values.
| Application scenario | Maximum residual moisture | Melt / die temperature | Mould, roll or sheet temperature | Maximum regrind fraction |
|---|---|---|---|---|
| Thermoformed sheet | 0.010% (100 ppm) | 200–210°C | 70–80°C sheet surface | 25 wt% |
| Injection blow moulded preforms | 0.025% (250 ppm) | 200–220°C | 10–15°C preform mould | 15 wt% |
| Injection-moulded cutlery | 0.010% (100 ppm) | 190–210°C | 25–40°C mould | 20 wt% |
| Extruded cup lid rollstock | 0.010% (100 ppm) | 200–210°C | 40–55°C rolls | 20 wt% |
| Single-serve capsule bodies | 0.015% (150 ppm) | 210–230°C | 30–45°C mould | 15 wt% |
| Extrusion blow-moulded dry-food jars | 0.010% (100 ppm) | 190–215°C | 30–40°C mould | 10 wt% |
For dry-food jars below 500 mL, extrusion blow moulding of impact-modified PLA is run on a 20:1 L/D extruder with 40–60 mm screw diameter and an accumulator head set to 190–215°C. The compound is fed at 100%; post-consumer regrind is not used in the food-contact layer, and post-industrial regrind is limited to 10 wt% because die swell consistency and parison sag become variable at higher recycled content. Blow moulding is performed at 6–9 bar into moulds maintained at 30–40°C, with drop time 2–5 s depending on jar height. Compliance includes FDA Food Contact Notification FCN 178, Commission Regulation (EU) No 10/2011 as amended, and EN 13432:2000. Terminal product types are 150–500 mL dry-food jars for tea, spices, and powdered beverage mixes; hot fill is restricted to below 55°C because sustained wall load at higher temperatures causes creep and thread deformation.
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RTP 2099 X 126217 Z is an impact-modified polylactic acid (PLA) compound distributed in cylindrical pellet form for injection molding, sheet extrusion, and thermoforming. The alphanumeric designation locates the material within the RTP 2099 bio-based polyester series: “X” marks a specialty modification, “126217” is the internal formulation identifier, and “Z” indicates the impact-modified, FDA-compliant, bio-based variant. The base polymer is a semi-crystalline PLA with a melt transition generally cited between 160 °C and 180 °C. Published data for this specific configuration is limited; therefore, the following ranges represent comparable impact-modified PLA grades and should be confirmed against a lot-specific certificate of analysis. Specific gravity measured by ASTM D792-20 is typically 1.22–1.28. Tensile strength by ASTM D638-22 is typically 35–55 MPa, tensile modulus is 2.0–3.2 GPa, and notched Izod impact by ASTM D256-23 is 0.8–3.0 ft-lb/in (43–160 J/m). Bio-based carbon content measured by ASTM D6866-22 may fall between 70% and 95% depending on impact-modifier loading. The FDA-compliant designation applies to the compounded formulation as supplied and must be verified under the final article’s food-contact conditions of use.
The product is specified for cold-fill and room-temperature food-contact disposables, cosmetic packaging trays, single-use diagnostic housings, and non-retort covers where improved notched impact and renewable carbon content are required. It differs from neat PLA by sacrificing transparency and stiffness for toughness, and from glass-filled PLA by providing lower density and smoother molded surfaces. Use in hot-fill, microwave, or retort applications is not implied.
Predrying is the primary control variable. In production-scale desiccant dryers, PLA compounds are typically dried at 80 °C for 4 h to a residual moisture level below 250 ppm (0.025%). Dew point should be held at or below -40 °C. Failure to maintain this threshold leads to hydrolytic chain scission, measured as an increase in ISO 1133-1:2022 melt flow rate at 210 °C/2.16 kg and a drop in notched Izod impact. On compounding lines with 30:1–40:1 L/D co-rotating twin-screw extruders, wet pellets have produced visible splay, die-face instability, and batch-to-batch melt flow rate drift when ambient relative humidity exceeded 60% during hopper residence.
Melt temperature should be kept below 210 °C; above 220 °C, PLA undergoes lactide reformation and molecular weight reduction. Residence time at 200 °C should not exceed 3 min. A reverse temperature profile from feed to die is preferred because shear heating can generate additional energy at the screw tip. Rheologically, impact-modified PLA exhibits lower apparent viscosity than neat PLA at equivalent shear rates; the power-law consistency index may decline by 20–35% depending on elastomer content. This lowers screw torque but narrows the die pressure window. Vacuum venting at -0.08 MPa and screw speeds of 250–400 rpm are typical on 36:1 L/D lines.
With injection molding, a 25–35 mm general-purpose screw with 20:1–24:1 L/D and compression ratio 2.0:1–2.5:1 is applied. Barrel zones are often set from feed to nozzle at 175–200 °C, with the nozzle at 190–205 °C; mold temperatures between 20 °C and 40 °C maximize impact, while mold temperatures of 55–60 °C improve dimensional stability but may reduce notched Izod due to higher crystallinity. Back pressure of 0.3–0.8 MPa and screw recovery sufficient to fill the shot in 1.5–3.0 s avoid excessive shear heating. Hot runner systems should use free-flowing channels with no dead spots; PLA degradation in an idle hot runner above 200 °C for 5 min can produce black specks and acrid odor. For critical food-contact parts, hot runner nozzles with thermal jackets and quick purging are preferred over internally heated torpedo tips where residence time is harder to control.
Impact modification in PLA typically uses immiscible core-shell elastomer domains of 0.5–2.0 μm dispersed in the PLA matrix. The mechanism is shear yielding and cavitation; the modifier lowers the glass transition onset from roughly 60 °C for neat PLA but does not eliminate notch sensitivity. Under ASTM D256-23, unmodified PLA often reports notched Izod values of 0.2–0.5 ft-lb/in (11–27 J/m); the addition of 5–15 wt% impact modifier can raise this to 0.8–3.0 ft-lb/in (43–160 J/m). The exact value for 126217 Z must be taken from the certificate of analysis.
| Test method / standard | Property | Typical impact-modified PLA range | Relevance to 126217 Z |
|---|---|---|---|
| ASTM D638-22 | Tensile strength | 35–55 MPa | Lower than neat PLA due to elastomer domains |
| ASTM D638-22 | Tensile modulus | 2.0–3.2 GPa | Reduced stiffness for tougher cold-fill parts |
| ASTM D256-23 | Notched Izod impact | 0.8–3.0 ft-lb/in | Primary toughness specification |
| ASTM D648-18 | Deflection temperature at 0.455 MPa | 50–60 °C | Defines upper cold-fill limit |
| ISO 1133-1:2022 | Melt flow rate at 210 °C/2.16 kg | 5–30 g/10 min | Monitors hydrolysis and regrind degradation |
| ASTM D6866-22 | Bio-based carbon | 70–95% | Declines as modifier loading increases |
Regrind up to 20% is generally processable if the regrind is dried to the same moisture target and is free of polymer contamination. Above 30%, notched impact may decline by 10–20% because modifier domain coalescence and PLA molar mass reduction are cumulative. This is a critical threshold for food-contact articles; if the regrind source is not from the same FDA-compliant lot, the compliance status of the finished article can be invalidated. Processors running closed-loop regrind on injection molding machines should monitor melt flow rate and color shift after every 50 cycles; a melt flow rate increase of more than 2 g/10 min from virgin value indicates hydrolysis or residence-time damage.
FDA compliance for impact-modified PLA is not a single material property; it is a regulatory status attached to the specific formulation and its intended conditions of use. The base PLA may be covered by a Food Contact Notification or by 21 CFR 174.5 if the polymer is listed as an indirect additive. Unlike polyolefin resins that are regulated under 21 CFR 177.1520, PLA does not fall within that specific section unless a modifier or copolymer component independently qualifies. Therefore, the processor must obtain documentation from the supplier that the exact additives in 126217 Z—including impact modifier, stabilizer, and lubricant—are cleared for food-contact application. Published data for this specific configuration is limited; no migration testing under 21 CFR 174.5 is provided in this document.
End-use verification is performed under the intended food simulants and temperature conditions described in FDA Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances. For cold-fill and room-temperature single-use articles, extraction testing may be conducted with 10% ethanol as an aqueous food simulant; for fatty foods, 95% ethanol or edible oil simulants may be used. When the article is not subjected to temperatures above 40 °C, the compliance boundary is easier to demonstrate. Hot-fill, retort, or microwave use above 60 °C should not be assumed; PLA has a deflection temperature under load of 50–60 °C at 0.455 MPa by ASTM D648-18, which limits dimensional stability in hot food-contact.
Compared with unmodified PLA, the impact-modified version reduces tensile modulus from 3.0–3.6 GPa to 2.0–3.2 GPa while raising notched Izod impact. Optical transparency decreases because dispersed elastomer domains of 0.5–2.0 μm scatter light. Bio-based carbon content by ASTM D6866-22 may fall from 95% for neat PLA to 70–90% for impact-modified PLA, depending on modifier loading. Bio-based carbon content measured under ASTM D6866-22 is not equivalent to compostability certification, which would require ASTM D6400-21 or EN 13432:2000 testing.
Compared with glass-fiber reinforced PLA under ASTM D638-22, tensile strength is lower by 20–40% and deflection temperature is lower by 10–20 °C; however, density is lower at 1.22–1.28 g/cm³ versus 1.35–1.45 g/cm³, and surface finish is smoother. Compared with fossil-based high-impact polystyrene, the product offers renewable carbon but has lower continuous service temperature, is hygroscopic, requires predrying, and may exhibit more notch sensitivity at low temperatures. It also shows lower mold shrinkage, approximately 0.3–0.5% versus 0.4–0.7% for high-impact polystyrene, but lower melt strength in sheet extrusion.
Storage recommendations include sealed moisture-barrier containers, warehouse temperature at or below 30 °C, relative humidity at or below 50%, and FIFO inventory control within 12 months of compounding. Pellets exposed to ambient relative humidity above 60% for 1 h may require additional drying; material transferred through regrind hoppers should be blanketed with dry air. Contamination boundaries are strict: avoid any admixture of polycarbonate, nylon, or acetal above 0.5 wt% because differences in melt temperature create solid inclusions that block hot runner gates. Avoid purging with amine-containing cleaning agents; PLA ester linkages are sensitive to alkaline hydrolysis. Use a low-viscosity acrylic or styrenic purge compound before and after shutdown. These limits, rather than the renewable-carbon designation, control whether the product remains processable and FDA-compliant in production.