| HS Code | 382276 |
| Productname | PURASORB PLC 7015 |
| Manufacturer | Corbion |
| Productgrade | Medical Device Grade |
| Chemicalname | Poly(L-lactide-co-caprolactone) |
| Monomerratio | 70:30 L-lactide:caprolactone (molar) |
| Casnumber | 65408-67-5 |
| Inherentviscosity | 1.5 dL/g in chloroform at 25°C |
| Appearance | White to off-white granules |
| Form | Granules or pellets |
| Glasstransitiontemperature | Approximately 15°C |
| Solubility | Soluble in chloroform, dichloromethane, and THF; insoluble in water |
| Storage | Store in a cool, dry place protected from moisture |
| Typicalapplication | Implantable medical devices and drug delivery systems |
As an accredited PURASORB PLC 7015 Medical Device Lactide-Caprolactone Copolymer factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | PURASORB PLC 7015 is packaged in 1 kg sealed, moisture-barrier foil bags under nitrogen for medical device lactide-caprolactone copolymer protection. |
| Container Loading (20′ FCL) | PURASORB PLC 7015 medical-device lactide-caprolactone copolymer, in moisture-protected drums on pallets, securely loaded into a clean, dry 20′ FCL container. |
| Shipping | PURASORB PLC 7015 is shipped as a non-hazardous, moisture-sensitive solid in sealed, nitrogen-purged foil pouches with desiccant. Transport cool and dry, typically refrigerated or on dry ice if specified. Protect from heat, moisture, and contamination; follow supplier packaging and storage instructions. Use appropriate secondary containment and label as non-dangerous goods. |
| Storage | Store in original, tightly sealed containers under cool, dry conditions, protected from moisture, heat, light, and oxidizing agents. Keep under inert gas if supplied. Recommended storage is refrigerated at 2–8°C. Allow sealed containers to equilibrate to room temperature before opening to prevent condensation. Avoid prolonged storage above 25°C and follow the supplier’s safety data sheet. |
| Shelf Life | Shelf life is 24 months from date of manufacture when stored unopened at 2–8°C, dry, protected from moisture and light. |
Where a braided multifilament absorbable suture requires a low-friction surface layer that resists axial shear during needle insertion and does not develop knot tack after ethylene oxide sterilisation, PURASORB PLC 7015 is applied as a solution coating from 2.0–4.0% w/v solute in a 70:30 dichloromethane:acetone carrier. The resin specification midpoint is 1.5 dL/g inherent viscosity measured at 0.1 g/dL in chloroform at 25 °C; the 70:30 L-lactide:ε-caprolactone molar ratio is fixed by the grade designation. The target coating add-on is 2.0–5.0 wt% of the finished suture mass. Coating is executed on a continuous horizontal dip-coating line with a closed-loop solvent recovery condenser at 45–55 °C; the coated braid then passes through a three-zone drying tunnel at 55–70 °C and vacuum drying at 0.05–0.10 kPa for 18–24 h. Residual moisture is held below 0.10 wt% because the ester backbone is moisture-sensitive above the glass transition. The processing conflict is humidity-dependent hydrolysis at ambient relative humidity above 60%; uncontrolled moisture uptake in the coating solution reduces molecular weight and increases surface tack. Industrial compliance is anchored to ISO 10993-1:2018 for biological evaluation planning, ISO 10993-5:2009 for cytotoxicity, ISO 10993-6:2016 for local effects after implantation, and ISO 10993-7:2008 for ethylene oxide residuals. Terminal product type: coated synthetic absorbable braided suture for general soft tissue closure.
An injectable in situ-forming depot is prepared by dissolving PURASORB PLC 7015 at 20–35 wt% in N-methyl-2-pyrrolidone or dimethyl sulfoxide, with an active pharmaceutical ingredient loaded at 10–30 wt% relative to polymer mass. The terminal dosage form is a single-dose prefilled syringe or vial that forms a biodegradable solid implant upon contact with aqueous tissue fluid at 37 °C. During subcutaneous or intratumoral injection through a 21G needle, solvent exchange removes the water-miscible solvent and triggers phase inversion; the rate of demixing controls burst release of the payload. When rapid demixing occurs, a more porous depot forms and release increases within the first 24 h. When dimethyl sulfoxide is used, water uptake is slower than with N-methyl-2-pyrrolidone, producing a denser outer skin and lower early release; however, solution viscosity also rises and injection force must be revalidated for needles narrower than 21G. Terminal sterilisation is performed by gamma irradiation at 25–40 kGy after aseptic filling because the concentrated solution cannot be sterile-filtered. Compliance requirements include residual solvent limits per ICH Q3C(R8) and USP <467>, biological evaluation per ISO 10993-1:2018, local tissue reaction per ISO 10993-6:2016, and systemic toxicity per ISO 10993-11:2017. The 70:30 L-lactide:ε-caprolactone ratio is process-critical: insufficient caprolactone content raises depot stiffness and creates fractured implant edges; published data for this specific configuration is limited, so pilot stability should include dimensional change after 48 h in phosphate-buffered saline at 37 °C and pH 7.4.
Melt processing of PURASORB PLC 7015 into a fixation screw is carried out on a co-rotating twin-screw extruder with L/D 44:1 and segmented kneading blocks configured for low-shear mixing. Barrel temperatures are set from 140 °C at the feed throat to 180 °C at the die; melt pressure is maintained at 8–14 MPa and screw speed is held at 150–250 rpm. Prior to compounding, pellets are vacuum-dried at 80 °C for 4–12 h to moisture ≤0.10 wt%. The dried compound is then injection molded on a reciprocating screw machine with clamp force 100–180 tonnes, screw diameter 22–30 mm, injection pressure 100–150 MPa, and mold temperature 15–25 °C. The formulation is processed neat because the 30% ε-caprolactone fraction acts as an internal flexibilizer; if radiopacity is required, 10–20 wt% barium sulfate is compounded in a separate masterbatch and let down to the final implant. A narrower processing window exists at the upper temperature limit: residence above 180 °C for more than 5 min accelerates caprolactone-rich segment scission, visible as a torque reduction of more than 5% and a decrease in die swell. The terminal product type is a bioresorbable interference screw or pin for cruciate ligament or small joint reconstruction. Compliance standards are ISO 13485:2016 for manufacturing quality systems, ASTM F1635-16 for in vitro degradation testing, ASTM D638-14 for tensile properties, ISO 1133-1:2022 for melt flow behaviour, and ISO 10993-13:2010 for identification and quantification of degradation products.
| Test endpoint | Standard designation | Boundary applied |
|---|---|---|
| Biological evaluation planning | ISO 10993-1:2018 | Cytotoxicity, implantation, systemic endpoints |
| Cytotoxicity | ISO 10993-5:2009 | Extract dilution series on L929 cells |
| Local effects after implantation | ISO 10993-6:2016 | Intramuscular or subcutaneous implant, 12–26 weeks |
| In vitro degradation | ASTM F1635-16 | Phosphate-buffered saline at 37 °C, pH 7.4 |
| Tensile properties | ASTM D638-14 | Specimen gauge length 25 mm, 23 °C, 50% RH |
| Ethylene oxide residuals | ISO 10993-7:2008 | Simulated use extraction per standard |
For peripheral nerve defects exceeding 10 mm, a hollow tubular conduit made from PLC 7015 is electrospun from 8–12% w/w solution in hexafluoroisopropanol or a 70:30 dichloromethane:dimethylformamide mixture. The solution is fed at 0.5–1.5 mL/h through a 21G blunt needle under 15–25 kV, while a rotating cylindrical mandrel with diameter 3–6 mm collects the fibre mat to a wall thickness 200–600 μm. Residual solvent is removed under vacuum at 0.05 kPa for 48 h; the conduit is then cut to 20–40 mm lengths and sterilised. The formulation is a neat polymer matrix; where a bioactive protein or peptide is immobilised on the luminal surface, the coating add-on is 0.1–1.0 wt% of total conduit mass and is applied after vacuum drying to avoid protein denaturation from residual solvent. The terminal product type is an absorbable nerve guidance conduit for peripheral nerve repair. Compliance requirements include ISO 10993-5:2009 for cytotoxicity, ISO 10993-6:2016 for local implantation response, and ASTM D882-18 for tensile properties of thin plastic sheeting. A known constraint is that the caprolactone-rich amorphous phase lowers kinking resistance relative to stiffer PLLA conduits; suture retention strength must therefore be verified on the finished conduit at 37 °C in saline, because published data for this specific configuration is limited.
A drug-eluting absorbable stent coating is prepared from PLC 7015 at 1–3% w/v in a 90:10 tetrahydrofuran:methanol carrier, with an antiproliferative agent loaded at 25–50 wt% relative to polymer. The coating is deposited by ultrasonic spray at 40–60 kHz, feed rate 0.1–0.3 mL/min, and nozzle-to-strut distance 10–15 mm; target strut-side coating thickness is 2–10 μm. After spray coating, the stent is vacuum-dried at 0.10 kPa and 30–35 °C for 48 h before crimping onto a balloon catheter. The critical process conflict is the crimping step: strut curvature imposes compressive strain above 20% on the coating surface, and any brittle fracture creates particulate release during deployment. The 30% caprolactone fraction reduces crystallinity and shifts the mechanical response from rigid crazing toward shear yielding under these strain rates; however, residual solvent above 0.05 wt% plasticises the coating and increases tack, causing coating transfer to the crimp jaws. The terminal product type is a drug-eluting bioresorbable vascular stent coating. Compliance standards include ISO 10993-1:2018 biological evaluation planning, ISO 10993-4:2017 hemocompatibility, ISO 10993-7:2008 ethylene oxide residuals, and ASTM F2477-19 for stent expansion and bending. Published data for this specific configuration is limited; stent coating adhesion should be verified by scanning electron microscopy after simulated deployment at 37 °C in 0.9% saline.
Barrier membranes for dental guided bone regeneration are cast from 5–8% w/v PLC 7015 in dichloromethane or melt-pressed at 140–160 °C into sheets of 100–300 μm. The polymer is used neat because the caprolactone-rich amorphous phase provides room-temperature ductility without plasticiser; if an osteoconductive particulate is added, the total filler content is limited to 5–15 wt% to preserve membrane tear resistance. Solvent-cast films are dried under a nitrogen sweep at 25–30 °C for 24 h, then vacuum dried at 0.10 kPa for 48 h to residual solvent below 0.10 wt%. The dried membrane is trimmed, pouch sealed, and terminally sterilised. The terminal product type is an absorbable non-woven or solid barrier membrane for periodontal regeneration. Compliance anchors are ISO 10993-1:2018, ISO 10993-6:2016 for submucosal implantation, and ASTM D638-14 for tensile strength and elongation at break. The operational boundary is hydration-dependent stiffening: once placed in the wound, absorbed water at 37 °C plasticises the amorphous phase, so the initial dry handling modulus is not representative of in situ flexibility; mechanical test specimens should be conditioned in phosphate-buffered saline at 37 °C for 1 h before tensile testing.
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PURASORB PLC 7015 Medical Device Lactide-Caprolactone Copolymer is supplied as an amorphous granulate for melt conversion into absorbable implant components. The product code communicates a 70:30 molar ratio of L-lactide to ε-caprolactone and a nominal inherent viscosity midpoint of 1.5 dL/g determined at 0.1 g/dL in chloroform at 25°C according to ISO 1628-1. The ε-caprolactone units interrupt L-lactide sequence regularity, thereby suppressing crystallinity under common melt-quench conditions. The resulting polymer matrix has a lower tensile modulus than semi-crystalline poly(L-lactide) and a longer hydrolytic degradation class than 50:50 poly(DL-lactide-co-glycolide). These differences are class-level and do not substitute for device-specific mechanical and degradation data.
Because the resin is amorphous and its glass transition is near or below body temperature under typical thermal histories, water uptake is more uniform than in semi-crystalline poly(L-lactide); hydrolysis proceeds through the bulk matrix rather than being concentrated at crystal boundaries. This does not permit prediction of in vivo mass loss from resin data alone. In vitro degradation testing under ASTM F1635-16 or ISO 10993-13 on the finished geometry is required. The product is an implant raw material, not a sterilised finished device. Device manufacturers must perform biological evaluation according to ISO 10993-1 and risk management under ISO 14971.
| Parameter | Value | Test method |
|---|---|---|
| L-lactide/ε-caprolactone molar ratio | 70:30 | 1H NMR |
| Inherent viscosity midpoint | 1.5 dL/g | ISO 1628-1 |
| Physical form | Amorphous granulate | ISO 11357-2 |
Batch-release documentation should be checked against the current certificate of analysis for residual monomer, residual tin, residual solvent, water content, and sulfated ash. Published data for this specific configuration is limited in peer-reviewed compilations; the supplier-controlled limits are the binding values for the device master record.
Residual moisture is the principal process variable before melt conversion. If water is present during extrusion or injection molding, hydrolytic chain scission reduces molecular weight and shifts the degradation profile. The amorphous pellet surface softens at low temperatures; drying therefore must remain below the sintering point of the granulate. A vacuum dryer or desiccant dryer with a dew point of -40°C or lower is used to reduce moisture below 250 ppm before processing. Water content is measured by Karl Fischer titration according to ISO 15512. When ambient relative humidity exceeds 60%, dried granulate is transferred to the feed throat under dry nitrogen purge.
Typical pilot-scale drying conditions of 40°C to 50°C for 8 to 12 h are used for low-Tg polyester copolymers; actual time depends on pellet bed depth, vacuum level, and dryer dew-point stability. Production-scale rotary vacuum dryers have shown slower moisture removal at fill volumes above 70% of working capacity because reduced pellet movement limits surface exposure. Published data for PLC 7015 at full commercial dryer loading is limited; qualification runs should include moisture mapping at multiple bed depths.
Incoming granulate is not assumed dry. A moisture specification on the certificate of analysis is not sufficient after a hopper has been opened in humid conditions. The feed system should include an enclosed hopper with nitrogen cap and a material dryer interlocked to stop extrusion when dew point or hopper temperature falls outside qualified ranges.
Melt conversion is performed on single-screw or twin-screw extruders with an L/D ratio of 24:1 to 40:1 or on injection molding machines with a shut-off nozzle to minimize drool. Barrel temperatures for the amorphous grade are typically held between 120°C and 160°C; because the material does not exhibit a sharp melting plateau, shear heating contributes significantly to the actual melt temperature. Production-scale single-screw extruders have shown melt-temperature overshoot when screw speed is increased without lowering barrel set points; torque control is therefore used below the maximum drive load. Capillary rheometry at shear rates of 10³ s⁻¹ to 10⁴ s⁻¹ is required to predict nozzle and gate pressure drop because a single ISO 1133-1 melt flow rate value does not capture shear-thinning behaviour.
Mold temperatures of 10°C to 25°C are commonly used to cool the amorphous melt against a chilled tool; higher mold temperatures may prolong cycle time because the polymer remains flexible above its glass transition. Residence time should be kept below 10 min at barrel temperatures above 180°C to limit lactide monomer regeneration and molecular-weight loss. Screw profiles for twin-screw compounding should use low-to-moderate kneading intensity; high-shear mixing elements can generate excessive viscous heating and reduce inherent viscosity. Published data for PLC 7015 in high-shear twin-screw operations is limited.
The material is incompatible with amine-based additives and strong alkaline fillers because these accelerate hydrolytic chain scission. For compounding, only moisture-free, neutral or acid-functional additives should be pre-blended. Melt filtration through a screen pack of 20 to 40 μm is used in some medical device extrusion lines to remove gels, but the filter housing must be designed to avoid dead spots where long residence time can generate degraded resin.
In monofilament suture lines, the amorphous PLC 7015 is extruded through a single-screw extruder with a 24:1 L/D and a water quench, then drawn at a draw ratio of 3:1 to 5:1 in a heated draw bath. Orientation increases tensile strength and reduces elongation; residual stress is relaxed in a subsequent off-line annealing step below the glass transition temperature. Published data for this specific configuration is limited; the draw ratio must be qualified on the target monofilament line. Production-scale experience in monofilament extrusion has shown die-lip build-up from low-molecular-weight fractions when barrel temperatures are too low; increasing die temperature within the qualified range reduces die-lip build-up.
In absorbable device design, PLC 7015 occupies an intermediate position between 50:50 poly(DL-lactide-co-glycolide) and poly(L-lactide) homopolymer. In vitro degradation per ASTM F1635-16 in phosphate-buffered saline at 37°C is geometry-dependent; small-diameter fibres, porous scaffolds, and thin films lose mass faster than large injection-molded parts. The absence of glycolide in PLC 7015 and the higher L-lactide content reduce the magnitude of the acidic degradation burst associated with glycolide-rich PLGA and extend bulk degradation. Exact mass-loss half-life values cannot be transferred across designs because surface-area-to-volume ratio, orientation, sterilization dose, and residual stress modify the hydrolysis rate.
Mechanical performance under load differs from PURASORB PL 18: the caprolactone comonomer reduces modulus and yield strength but increases strain capability. Testing of finished components under ISO 527-1 or ASTM D638-14 is required because resin-level tensile data do not predict device performance. The copolymer is more flexible than lactide homopolymer but should not be considered an elastomer without plasticisation; cyclic loading and creep properties must be evaluated for load-bearing applications. Published data for this specific configuration in cyclic fatigue is limited.
| Material class | Monomer ratio | Crystallinity | Relative degradation class | Representative PURASORB grade |
|---|---|---|---|---|
| Poly(L-lactide) | 100:0 | Semi-crystalline | Slow | PURASORB PL 18 |
| L-lactide/ε-caprolactone | 70:30 | Amorphous | Intermediate | PURASORB PLC 7015 |
| DL-lactide/glycolide | 50:50 | Amorphous | Rapid | PURASORB PDLG 5010 |
The table is a class-level guide only; it does not replace device-specific degradation studies. A supplier change from PURASORB PDLG 5010 to PLC 7015 is not a drop-in substitution because processing temperatures, drying conditions, and mechanical design margins must be re-established. Drug-eluting applications may require an additional biocompatibility assessment of the loaded and released drug substance under ISO 10993-4 for blood contact if the device reaches circulating blood.
Terminal sterilisation is selected after processing. Ethylene oxide cycles are generally used because the low-Tg amorphous copolymer can be processed without high heat; residual ethylene oxide and ethylene chlorohydrin limits are assessed under ISO 10993-7. Gamma irradiation at 25 kGy can reduce molecular weight and shift the degradation curve; dose mapping according to ISO 11137-1 on the packaged device is required. Steam sterilisation at 121°C is not appropriate because the temperature exceeds the glass transition and may distort the device. The final implant configuration must be qualified for cytotoxicity under ISO 10993-5, irritation under ISO 10993-10, systemic toxicity under ISO 10993-11, and chemical characterisation under ISO 10993-18. Incompatibility with alkaline buffers and amine-based drugs must be evaluated during formulation because these agents accelerate hydrolysis and alter the designed mass-loss profile.
