| HS Code | 720448 |
| Productname | PURASORB PL 10 Medical Device Poly(L-lactide) |
| Chemicalname | Poly(L-lactide) |
| Synonym | Poly(L-lactic acid) |
| Casnumber | 26100-51-6 |
| Chemicalformula | (C3H4O2)n |
| Polymertype | L-lactide homopolymer |
| Appearance | White to off-white granules |
| Form | Granules/pellets |
| Inherentviscosity | 0.9–1.1 dL/g (chloroform, 25 °C) |
| Glasstransitiontemperature | 55–65 °C |
| Meltingpoint | 170–180 °C |
| Density | 1.24–1.30 g/cm³ |
| Solubility | Soluble in chloroform, dichloromethane, dioxane; insoluble in water and ethanol |
| Residualmonomer | ≤0.5% |
| Watercontent | ≤0.5% |
| Heavymetals | ≤10 ppm |
| Storage | Store sealed, cool, dry, protected from moisture; long-term storage typically at -20 °C |
| Degradationproduct | Lactic acid |
| Medicalgrade | Medical device grade |
As an accredited PURASORB PL 10 Medical Device Poly(L-lactide) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | PURASORB PL 10 Medical Device Poly(L-lactide) is supplied in 1 kg moisture-barrier foil bags inside fiber drums. |
| Container Loading (20′ FCL) | 20′ FCL loading: PURASORB PL 10 Medical Device Poly(L-lactide), palletized, dry, moisture-protected, securely strapped, and stowed in a ventilated container. |
| Shipping | PURASORB PL 10 Medical Device Poly(L-lactide) ships as a non-hazardous, non-regulated solid in sealed moisture-barrier foil bags, often under nitrogen, packed in fiber drums. Store cool, dry, and protected from heat/moisture. No UN number, hazard class, or special transport documentation is required; follow supplier instructions. |
| Storage | Store PURASORB PL 10 in a tightly closed, original container in a cool, dry, well-ventilated place. Keep refrigerated at 2–8°C, protected from moisture, heat, light, and oxidizing agents. Use a desiccant; for long-term storage, use an inert atmosphere. Equilibrate to room temperature before opening to avoid condensation. Store away from incompatible materials and ignition sources. Follow the manufacturer’s SDS. |
| Shelf Life | PURASORB PL 10 has a 2-year shelf life when stored unopened, cool, dry, and protected from moisture, heat, and light. |
Injection moulding of PURASORB PL 10 for cruciate ligament interference screws and glenoid suture anchors proceeds from pellets that are vacuum-dried at 80°C for 4–6 h to a residual moisture level below 250 ppm; line-side dryers with a dew point of −40°C are mandatory when floor relative humidity exceeds 60%. The material is metered into a 20:1 to 25:1 L/D single-screw injection unit with barrel zones set between 180°C and 205°C, nozzle 195°C, and mould temperature maintained at 20–35°C to retain an amorphous skin that improves thread detail. Formulation control for neat PL 10 specifies 100 wt% resin at the press; calcium phosphate fillers, when used for acid buffering, are added at 10–30 wt% β-tricalcium phosphate, but loadings above 30 wt% reduce melt strength and produce nozzle drool and shot-weight drift greater than ±1.0%. Injection pressure is kept at 800–1,100 bar, holding pressure 400–600 bar, and back pressure 5–10 bar; screw rotation below 120 rpm avoids shear-induced chain scission. Incoming lot IV is confirmed at 0.9–1.1 dL/g per ISO 1628-1:2009; post-moulding IV retention above 90% is used as a batch-release proxy for molecular weight stability. Regulatory conformance for these load-bearing resorbable fixation devices is defined by ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, USP <88> Class VI, ASTM F1925-22, ASTM F2502-17, and ISO 13781:2017; terminal sterilisation is normally ethylene oxide validated under ISO 11135:2014 with residual limits per ISO 10993-7:2008. The downstream terminal product set includes ACL interference screws, tibial and femoral screw sizes from 7 mm to 11 mm, glenoid suture anchors, and small osteochondral fixation pins. Field data from moulding lines show that failure to keep the hot runner volume below 2 mL generates black specks and increases free lactide monomer, which shifts degradation onset.
Conversion of PURASORB PL 10 into orbital floor plates and midface osteosynthesis plates uses compression moulding or sheet extrusion followed by low-temperature thermoforming. The pellets are dried at 80°C under 10 mbar vacuum for 4 h, pressed at 185–195°C into sheets between 0.5 mm and 2.0 mm, and quenched rapidly to produce an amorphous sheet with less than 5% crystallinity. Thermoforming is performed at 60–70°C, just above the 55–60°C glass transition, using aluminium tooling heated to 65°C; forming above 75°C induces spherulitic growth that raises modulus but reduces ductility at screw holes. The addition ratio for these devices is 100 wt% PL 10; no plasticiser, nucleant, or impact modifier is commonly added because plate contouring relies on the amorphous state. If radiographic visibility is needed, barium sulfate can be compounded at 5–10 wt%, but the 10 wt% filler level reduces elongation at break in published PLLA composite data by approximately 20–50%, which should be confirmed on device geometry. Intraoperative shaping on the sterile back table uses a heated saline bath at 55°C for 30–60 s; field observations indicate that reheating beyond five cycles increases opacity and causes localised stress whitening near plate holes. Regulatory requirements include ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ASTM F2502-17, ISO 13485:2016, and packaging validation under ISO 11607-1:2019. Finished devices are typically platelet-shaped orbital floor implants, L-shaped and straight midface plates, and 2.0 mm or 2.4 mm diameter self-tapping resorbable screws. These plates are not indicated for load-bearing mandibular reconstruction because the flexural modulus of amorphous PL 10 is lower than cortical bone and drops further during hydrolysis.
Because radial strength after laser cutting depends on molecular orientation frozen during cold drawing, tube extrusion from PURASORB PL 10 for fully resorbable vascular scaffolds is controlled more tightly than injection moulding. Published data for PURASORB PL 10 in vascular scaffold tube stock is limited; the processing window below reflects general PLLA coronary scaffold platform data and should be re-qualified on device-specific tooling. Pellets are dried to below 200 ppm and fed to a 24:1 L/D single-screw extruder with barrel temperatures of 180–210°C and a precision annular die at 190°C. The melt is drawn over a 1–2 mm mandrel and quenched in a water bath at 15–20°C to set tube dimensions; wall thickness is controlled to 150–180 µm for coronary designs and outer diameter to 3.0 mm. The formulation is 100 wt% PL 10 because any low-molecular-weight plasticiser or copolymer above 5 wt% reduces radial strength below the acute recoil limit in ASTM F2079 and ISO 25539-2:2020. Sectioning by femtosecond laser at 1030 nm with pulse duration below 800 fs keeps the heat-affected zone below 5 µm; nanosecond UV laser processing is an alternative, but thermal input above 2 J/mm² produces edge voids that act as crack initiators during crimping. Crimping onto the delivery balloon is performed at 50–55°C to avoid crazing below the 55–60°C Tg. In vitro degradation testing follows ISO 13781:2017; hemocompatibility is tested per ISO 10993-4:2017; implantation response is evaluated under ISO 10993-6:2016; and absorbable stent guidance falls under ASTM F3036. Ethylene oxide sterilisation per ISO 11135:2014 is preferred; gamma sterilisation above 15 kGy produces measurable IV loss and shifts radial strength durability. Terminal products are fully resorbable coronary scaffolds and below-knee peripheral scaffolds. A process conflict occurs in die lip residence time: residence above 3 min at 190°C increases free lactide above 0.5 wt% and requires offline IV checks before tube release.
For injectable soft-tissue volume restoration, PURASORB PL 10 is converted into spherical microparticles by oil-in-water emulsion solvent evaporation, not by melt processing. PL 10 pellets are dissolved in dichloromethane at 5–10% w/v; the organic phase is dispersed into an aqueous continuous phase containing 0.5–1.0 wt% poly(vinyl alcohol) and stirred at 300–500 rpm in a jacketed reactor held at 25°C. Vacuum is applied gradually to 500 mbar to remove solvent; the slurry is wet-sieved to isolate the 40–63 µm fraction, washed with water for injection, and lyophilised for 24–48 h. The addition ratio for the final injectable suspension is a dispersed solid load of 150 mg PL 10 microparticles per 5 mL vehicle; the vehicle is typically 0.9% sodium chloride with 0.5–1.0 wt% carboxymethylcellulose. Particle size below 40 µm increases macrophage uptake, while above 63 µm increases patient-reported nodule palpability; this range is therefore a release criterion. Residual dichloromethane is measured by headspace gas chromatography according to ISO 10993-18:2020 and assessed under ISO 10993-17:2023; levels above 600 ppm are rejected because the toxicological threshold derived under ISO 10993-17:2023 is approached. Cytotoxicity is evaluated per ISO 10993-5:2009, irritation and delayed hypersensitivity per ISO 10993-10:2010, and risk management per ISO 14971:2019. Terminal sterilisation is by ethylene oxide under ISO 11135:2014; gamma radiation above 15 kGy induces measurable viscosity loss and is not recommended for PL 10 microparticles. Field-scale batches show that solvent evaporation rate above 2 L/h causes particle coalescence and bimodal size distribution; therefore the jacket temperature ramp is limited to 0.5°C/min. The terminal finished products are injectable PLLA suspensions used for volume restoration in facial lipoatrophy, depressed dermal scars, and age-related midface volume deficits. Bulk PLLA mass loss is reported in literature as occurring beyond 24 months; clinical persistence must be confirmed in the manufacturer’s clinical evaluation plan.
PL 10 filament for fused filament fabrication is extruded from pellets at 175–190°C through a 2.0 mm die, cooled in air, and pulled to 1.75 ± 0.05 mm diameter; spooled filament is dried at 60°C for 12 h before printing. The FFF toolpath uses a nozzle temperature of 200–220°C, heated bed at 55–60°C, chamber temperature 25–35°C, layer height 0.10–0.20 mm, and print speed 30–50 mm/s to limit extrusion backpressure. Formulation remains 100 wt% PL 10 for most patient-specific implants; hydroxyapatite may be compounded at 5–10 wt% for osteoconductivity, but above 10 wt% nozzle clogging on 0.4 mm nozzles occurs and requires larger 0.6 mm orifices plus melt filtration. Post-print annealing at 100°C for 2 h under vacuum increases crystallinity and reduces stress concentrators between raster contacts. The printed construct is then machined or hand-finished to remove support remnants. Published data for PL 10-specific fused filament mechanical anisotropy is limited; in amorphous PLLA prints, tensile strength perpendicular to build direction is commonly 40–50% lower than injection-moulded stock, so load-bearing defect reconstruction requires isotropic design compensation. Regulatory conformance includes ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO/ASTM 52900:2021 for additive manufacturing terminology, and ISO 13485:2016. Terminal products are patient-specific cranial defect plates, orbital reconstruction implants, and pre-surgical cutting guides. Process limitation: warping at bed edges above 40 mm length is controlled with a 10 mm brim and a sealed chamber held below 35°C; open-frame printers are unsuitable when floor relative humidity exceeds 60% because filament hydrolyses during printing.
Electrospun guided bone regeneration (GBR) membranes from PL 10 use a solution of 10–14 wt% polymer in 70:30 v/v chloroform:dimethylformamide; the solution is fed at 0.5–1.0 mL/h through a 21-gauge blunt needle charged to 18–25 kV, with a grounded collector maintained at 2000 rpm rotating drum speed. Electrospinning under 40% relative humidity is avoided because water vapour de-stabilises the Taylor cone and creates bead-on-string defects. The 10–14 wt% solution concentration is the formulation addition parameter: below 10 wt% fibre diameter falls below 500 nm and membrane tensile strength drops, while above 14 wt% fibre diameter rises above 1.5 µm and pore size declines below the 10–20 µm window required for fibroblast exclusion. The collected membrane is vacuum-dried at 40°C for 48 h to reduce residual solvent, then cut into 20 mm × 25 mm and 30 mm × 40 mm sheets. Regulatory conformance includes ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and dental barrier standards such as ISO 22794:2009; if the membrane incorporates no pharmacologic agent, the device is classified as a Class IIb resorbable dental barrier under MDR or transitional 93/42/EEC. Terminal products are GBR membranes for periodontal defects, alveolar ridge preservation, and fenestration coverage around dental implants. The membranous form is not suitable for tensile fixation; suturing must be limited to pre-formed holes to prevent tear propagation along fibre alignment.
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PURASORB PL 10 Medical Device Poly(L-lactide) is a semicrystalline, hydrolytically degradable homopolymer based on the L-lactide repeat unit. The grade designation PL 10 corresponds to a nominal intrinsic viscosity of 1.0 dL/g measured in chloroform at 25 °C and 0.1 g/dL. This places the material at the lower-molecular-weight end of the PURASORB poly(L-lactide) portfolio, where higher numerical suffixes indicate higher nominal intrinsic viscosity. The polymer is manufactured under a quality management system certified to ISO 13485:2016 and is intended for conversion into resorbable medical device components, including short-term tissue fixation, thin-wall injection-molded implants, suture anchors, and solvent-processed drug delivery matrices. Because the material is designated as a medical device polymer, biological evaluation of the final sterilized device is normally conducted according to ISO 10993-1:2018, with the endpoint matrix defined by contact duration and route. Each lot is traceable and accompanied by a certificate of analysis that reports intrinsic viscosity, residual lactide, residual catalyst, and residual solvents. Compared with industrial-grade polylactide, PURASORB PL 10 excludes intentional additives, plasticizers, and nucleating agents and is controlled to narrower monomer and oligomer limits. Published data for every final-device configuration is limited; performance must be verified on the target geometry under validated manufacturing conditions.
The principal lot-release parameter is intrinsic viscosity because solution viscosity in chloroform is more reproducible across batches than melt flow for low-moisture medical PLLA. The nominal midpoint of 1.0 dL/g is not a specification in isolation; the allowed variation around the midpoint is defined in the supplier release specification and is verified by dilution viscometry using Ubbelohde-type or equivalent capillary viscometers. Residual solvent controls follow ICH Q3C and USP <467> concepts where the polymer is used in drug delivery implants; residual chloroform, dichloromethane, or dioxane from solvent-based conversion must be below the limits applicable to the final drug product. Residual lactide and residual tin are monitored because free lactide forms acidic degradation products in vivo, while tin residues are associated with accelerated chain scission. High-purity medical PLLA suppliers frequently control residual lactide below 0.5 wt% and residual tin below 20 ppm; however, the current PURASORB PL 10 certificate of analysis should be consulted for exact lot-specific limits. Thermogravimetric analysis under nitrogen at 10 K/min is used to measure volatile content, and differential scanning calorimetry is used to confirm the semicrystalline character after annealing. The polymer is not specified by a single molar mass value because the Mark-Houwink relationship for PLLA in chloroform carries an uncertainty that is larger than the batch variation at a fixed intrinsic viscosity.
Before melt conversion, PURASORB PL 10 must be dried to prevent hydrolytic degradation during plastication. In production-scale injection molding and extrusion, residual moisture should be reduced below 250 ppm by vacuum drying at 60–80 °C for 4–12 h, depending on initial exposure and bed depth. Injection-molding machines with screw L/D ratios of 18:1 to 22:1 and clamp forces above 500 kN are typical for thin-wall parts. Twin-screw compounding lines with 30:1 L/D or greater are used for dispersion-intensive formulations, with vacuum venting applied to remove trace volatiles. Barrel temperatures for PLLA are ordinarily maintained between 180 °C and 200 °C; melt temperatures above 220 °C increase chain scission, lactide regeneration, and discoloration within typical residence times. Screw recovery time should be recorded because drift at constant backpressure and screw speed is an early indication of molecular weight loss or feed-bridge formation. Processors should avoid amine-containing additives, catalytic metal stearates, and prolonged exposure to humid ambient air because aminolysis and hydrolysis compete with the intended ester cleavage pathway. Published data for PL 10-specific melt viscosity at shear rates above 1000 s⁻¹ is limited; mold-filling behavior should be characterized on the target mold using in-mold pressure sensors rather than inferred from general PLLA rheology.
At the nominal intrinsic viscosity of 1.0 dL/g, PURASORB PL 10 has lower entanglement density and lower melt viscosity than PURASORB PL 18, PL 24, or PL 32, but it also has lower molecular weight and faster mass-loss kinetics in aqueous environments. Higher-IV PLLA grades are generally selected when the implant must retain mechanical strength beyond 26 weeks. PURASORB PL 10 is preferred for thin-wall injection-molded components, short-term tissue fixation, and solvent-processed drug delivery matrices where prolonged strength retention is not required. Compared with 50:50 poly(D,L-lactide-co-glycolide), the PLLA homopolymer is semicrystalline and exhibits a melting endotherm near 170–180 °C after annealing, whereas 50:50 PLGA is amorphous and typically undergoes faster hydrolytic mass loss. This distinction is process-relevant because PLLA can be annealed to raise heat-deflection temperature and modulus, while amorphous PLGA cannot be thermally crystallized. Against industrial PLLA, PURASORB PL 10 differs principally in purity, traceability, and biocompatibility documentation rather than in backbone chemistry. The L-lactide repeat unit is the same; the medical grade designation changes the user requirements under ISO 13485:2016, ISO 10993, and the applicable regulatory framework such as EU MDR 2017/745 or FDA 21 CFR Part 820.
Sterilization method selection for PURASORB PL 10 devices should account for the effect of radiation on the polyester backbone. Gamma irradiation at 25 kGy can reduce molecular weight by radical-mediated chain scission, shifting mechanical properties and degradation profile; this effect is measurable by intrinsic viscosity when dose is applied to dry or moisture-equilibrated specimens. Ethylene oxide processing is used for moisture-sensitive resorbable polymers and is validated under ISO 11135:2014, with residual ethylene oxide and ethylene chlorohydrin limits in the final device addressed by ISO 10993-7:2008. Electron beam irradiation may produce a narrower dose distribution but can generate local heating; published data for PL 10-specific electron beam dose response is limited. Post-sterilization aging under controlled conditions must be part of design validation because the polyester continues to equilibrate with ambient moisture and can undergo physical aging that reduces impact properties. When devices are packaged under nitrogen with desiccant, hydrolytic degradation is slowed, but residual oxygen should be monitored because oxidative degradation may superimpose on hydrolysis. Autoclaving PL 10 devices in the presence of water is not appropriate because combined heat and moisture above 100 °C rapidly reduces molar mass.
Annealing of injection-molded or extruded PURASORB PL 10 is used to increase crystallinity, reduce residual stress, and improve dimensional stability above the glass transition. The annealing window for poly(L-lactide) homopolymers is 100–120 °C for 1–4 h, provided the part is constrained in a fixture that prevents distortion. At temperatures below 100 °C, crystallization is slow; above 130 °C, uncontrolled spherulite growth can embrittle the part. Differential scanning calorimetry at 10 K/min shows a glass transition near 60–65 °C, a cold crystallization exotherm near 100–110 °C, and a melting endotherm near 170–180 °C. The annealing process consumes the cold crystallization exotherm and raises the heat-deflection temperature of the finished component. Annealed PLLA has higher tensile modulus but lower elongation at break than amorphous PLLA of the same molecular weight; this trade-off must be evaluated according to ISO 527-1:2019 or ASTM D638-22 on specimens cut from the actual device or molded under identical conditions. Melt flow rate may be measured by ISO 1133-1:2022 at 190 °C/2.16 kg for comparative purposes, but intrinsic viscosity remains the lot-release parameter. Published data for PL 10-specific modulus retention after annealing is limited; designers should not substitute values from higher-IV PLLA grades without confirming on the target lot.
At production scale, batch-to-batch viscosity variation can be amplified by insufficient feedstock control and by moisture ingress through open granulate containers. In an injection-molding cell with clamp force above 500 kN, adequate melt cushion stability and shot-to-shot mass consistency require that the granulate be fed from a dry-air hopper with dew point below -30 °C. For extrusion, a gear pump between the die and the screw is often used to stabilize output when melt viscosity is low; screen packs with 100 mesh or finer are selected to remove char particles but may increase residence time. Processors running PL 10 on equipment previously used for poly(L-lactide-co-glycolide) must purge thoroughly because residual PLGA lowers crystallinity and accelerates degradation of the subsequent PLLA melt. These operating boundaries are not product-specific to PL 10 but are derived from general semicrystalline polyester processing practice; published data for this specific configuration is limited.
In vitro degradation of PURASORB PL 10 is assessed under ASTM F1635-16 or ISO 13781:2017 using buffered media at 37 °C, with periodic measurement of mass loss, intrinsic viscosity, pH, and mechanical properties. Hydrolysis of the ester backbone produces lactic acid, which lowers local pH and accelerates autocatalytic degradation in the core of thick specimens; this autocatalysis can create a hollow-shell morphology in large monoliths. Therefore degradation data from a 1 mm injection-molded tensile bar cannot be applied directly to a 3 mm or 5 mm orthopedic pin because the diffusion path length for acidic oligomers changes. The test method requires reporting buffer replacement interval; increasing buffer replacement frequency removes soluble oligomers and slows the autocatalytic effect. For PL 10, published data for site-specific strength retention in large orthopedic geometries is limited; design validation should include mechanical testing after aging according to ASTM D638-22 or ISO 527-1:2019 at intervals that bracket the intended residence time. In vivo, enzymatic activity does not dominate PLLA degradation, but local vascularity, pH buffering capacity, and micromotion influence the overall resorption rate. The in vitro buffer model is therefore a comparative tool, not a direct predictor of resorption time.
Standards commonly applied to PURASORB PL 10 lot release and final device validation are summarized below.
| Standard or regulation | Title or scope | Application to PURASORB PL 10 |
|---|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes | Manufacturing and batch traceability |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | Final device biocompatibility endpoint selection |
| ISO 10993-7:2008 | Ethylene oxide sterilization residuals | Sterilization residue limits after EO processing |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for development, validation and routine control | EO sterilization validation |
| ASTM F1635-16 | Standard test method for in vitro degradation testing of hydrolytically degradable polymer resins and fabricated forms for surgical implants | Hydrolysis assessment |
| ISO 13781:2017 | Implants for surgery — Hydrolytically degradable polymers for surgical implants | Polymer characterization and degradation |
| ISO 527-1:2019 | Plastics — Determination of tensile properties — Part 1: General principles | Tensile property measurement |
| ICH Q3C | Impurities: Residual solvents | Residual solvent control for solvent-processed devices |
Solvent-based processing of PURASORB PL 10 for microspheres and drug-elution matrices requires separate control of dioxane, dichloromethane, or chloroform residuals because the lower intrinsic viscosity permits dissolution at lower solids content than high-IV PLLA. Emulsion processes using poly(vinyl alcohol) as surfactant require exhaustive aqueous extraction to remove residual surfactant from the polymer surface; otherwise the local inflammatory response may be altered. Solvent evaporation conditions, continuous phase pH, and drug loading are not fixed by the polymer grade and must be optimized because residual solvent levels influence glass transition and drug release lag phase. Published data for PL 10-specific solvent processing is limited.
