| HS Code | 876973 |
| Material | Polypropylene Homopolymer |
| Density | 0.905 g/cm³ |
| Melt Flow Rate | 5.0 g/10 min (230°C/2.16 kg) |
| Tensile Strength At Yield | 35 MPa |
| Elongation At Yield | 10% |
| Flexural Modulus | 1400 MPa |
| Notched Izod Impact 23 C | 3.0 kJ/m² |
| Heat Deflection Temperature 0 45 Mpa | 100 °C |
| Heat Deflection Temperature 1 8 Mpa | 55 °C |
| Vicat Softening Temperature | 152 °C |
As an accredited MedSelect PP Homopolymer H0500HN factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | MedSelect PP Homopolymer H0500HN is supplied as polypropylene pellets in 25 kg moisture-resistant sealed bags. |
| Container Loading (20′ FCL) | 20′ FCL shipment of MedSelect PP Homopolymer H0500HN, palletized in sealed bags, securely loaded for safe transport. |
| Shipping | MedSelect PP Homopolymer H0500HN ships as dry, free-flowing pellets in sealed, moisture-barrier bags or bulk containers. Transport at ambient temperatures, protected from moisture, heat, and contamination. Non-hazardous under transport regulations; still, use clean, covered vehicles. Maintain traceability via product labels and certificates of analysis. Avoid prolonged storage in direct sunlight or high humidity. |
| Storage | Store MedSelect PP Homopolymer H0500HN in a cool, dry, well-ventilated area, away from direct sunlight, heat sources, and open flames. Keep containers tightly sealed to prevent moisture pickup and contamination. Avoid prolonged UV exposure. Maintain stable temperatures, protect from physical damage, and use within recommended shelf life. |
| Shelf Life | Shelf life is two years from date of shipment when stored in original packaging in a cool, dry area. |
MedSelect PP Homopolymer H0500HN is routed into multi-cavity thin-wall diagnostic consumables where nominal wall sections fall between 0.4 mm and 1.2 mm. The material is dried in a closed-loop dehumidifying circuit at -40 °C dew point when plant relative humidity exceeds 60%, then plasticised through a 24:1 L/D general-purpose screw with a reverse-cut barrier zone and compression ratio between 2.3:1 and 2.6:1. Melt temperature is maintained at 230 °C to 250 °C, mould temperature at 20 °C to 40 °C, injection speed at 150 mm/s to 300 mm/s, and hold pressure at 600 bar to 1,000 bar. Cavity pressure data from 32-cavity valve-gated hot-runner tools indicate that gate freeze time falls below 1.8 s at a wall stock of 0.6 mm, requiring hold-pressure switchover at 95% to 98% of stroke to avoid short shots and post-ejector warpage. The compliance chain references FDA 21 CFR 177.1520(c), USP <661.1>, ISO 10993-5:2009 for cytotoxicity, and ISO 13485:2016 for device-level quality records. Typical feed formulation comprises 98.5 wt% to 99.8 wt% neat H0500HN, 0.05 wt% to 0.20 wt% of a sorbitol-based clarifier/nucleating agent, and 0.10 wt% to 0.30 wt% of an antistatic masterbatch where automated plate stacking demands surface resistivity below 1 × 1013 Ω/sq per IEC 61340-5-1. Flatness across a 128 mm × 86 mm qPCR plate is controlled by keeping core temperature below 60 °C at ejection and by limiting ejector-pin differential stroke to 0.15 mm; warpage above 0.3 mm across the diagonal is considered a process deviation. End products include 96-well PCR plates, 384-well microplates, deep-well extraction blocks, and diagnostic cartridge bases.
Disposable syringe barrels and plunger rods moulded from H0500HN are sterilised by gamma or electron-beam irradiation at doses from 25 kGy to 50 kGy per ISO 11137-1:2006/Amd 1:2013 and ISO 11137-2:2013. The homopolymer chain generates tertiary carbon radicals under ionising radiation; if the antioxidant package is unbalanced, post-irradiation oxidation increases yellowness index by more than 4 units after 90 days of ambient ageing when measured per ASTM E313-20. Production-scale operation uses clamp force between 110 t and 250 t, wall stock of 1.5 mm to 2.5 mm, melt temperature of 225 °C to 245 °C, and mould temperature of 8 °C to 20 °C to freeze Luer cone geometry without gate blush. The formulation is 99.7 wt% to 99.9 wt% neat resin, 0.05 wt% to 0.15 wt% primary sterically hindered phenolic antioxidant, and 0.05 wt% to 0.15 wt% organophosphite secondary antioxidant; primary phenolic content above 0.20 wt% is avoided because excess phenolics are a documented source of irradiation-induced quinoid discolouration. Cavity-to-cavity cycle variation of 2.0 s to 3.5 s occurs when mould temperature control drifts beyond ±3 °C, a defect corrected by independent manifold zoning. Compliance is anchored to ISO 7886-1:2017 for sterile hypodermic syringes, FDA 21 CFR 177.1520(c), USP Class VI, and ISO 10993-5:2009. End products include Luer lock syringe barrels, plunger rods, and injection ports.
| Application scenario | Binding standards and test instruments | Critical endpoint or inspected property |
|---|---|---|
| Thin-wall diagnostic plates and cartridges | FDA 21 CFR 177.1520(c), USP <661.1>, ISO 10993-5:2009, ISO 13485:2016 | Cytotoxicity, extractables, dimensional flatness, surface resistivity per IEC 61340-5-1 |
| Disposable syringe barrels and plungers | ISO 7886-1:2017, ISO 11137-1, ISO 11137-2, FDA 21 CFR 177.1520(c), USP Class VI | Post-irradiation yellowness index per ASTM E313-20, sterility dose audit, Luer cone dimensional retention |
| Rigid sterile barrier packaging and lidding | ISO 11607-1:2019, ISO 11607-2:2019, FDA 21 CFR 177.1520(c), REACH EC 1907/2006 | Seal strength, microbial barrier, lid opening force, additive migration kinetics |
| Rapid lateral-flow cassette housings | IVDR 2017/746, ISO 13485:2016, ISO 15223-1:2021, ISO 10993-5:2009 | Dimensional stability under humidity cycling, component interface flatness, cytotoxicity |
| Centrifuge tubes and laboratory consumables | ISO 13485:2016, IEC 61010-2-101, FDA 21 CFR 177.1520(c), ISO 10993-5:2009 | Centrifugation leakage, autoclave distortion threshold, capillary tip clarity |
| Nonwoven medical apparel and mask stock | EN 13795-1:2019, AAMI PB70:2012, ISO 13688:2013, FDA 21 CFR 177.1520(c), ISO 10993-10:2010 | Air permeability, microbial penetration, skin irritation, basis-weight stability |
Rigid tray inserts and snap-fit lidding components produced from H0500HN are used in sterile barrier systems for catheter kits, wound-care trays, and surgical procedure sets. Injection moulding is conducted at melt temperatures from 235 °C to 255 °C, mould temperatures from 15 °C to 35 °C, and cycle times from 18 s to 35 s depending on draw depth and gate count. The formulation is 96.0 wt% to 99.8 wt% H0500HN, 0.2 wt% to 0.5 wt% erucamide slip additive to stabilise opening force below 1.5 N per ISO 11607-1:2019, and 0.05 wt% to 0.15 wt% antiblock to prevent film-to-tray blocking after storage at 40 °C for 72 h. Migration kinetics of the slip agent are controlled by melt temperature and cooling rate; coefficient of friction below 0.35 per ISO 8295:1995 is expected only after surface bloom reaches equilibrium. Sterilisation compatibility is limited to ethylene oxide at 55 °C and 60% relative humidity or hydrogen peroxide plasma below 60 °C; autoclaving at 121 °C distorts flange geometry because heat deflection load capacity of unfilled homopolymer PP drops as temperature approaches the crystallite softening point. Published data for this specific configuration is limited for hydrogen peroxide plasma beyond 5 cycles. End products include rigid tray inserts, snap-fit lidding components, and peel-away cover strips.
Rapid lateral-flow cassette housings require dimensionally stable top and bottom shells because the nitrocellulose test strip can exert a buckling load of 15 N to 35 N when the cassette is pressed into a reader slot. H0500HN is moulded at a melt temperature of 230 °C to 248 °C and a mould temperature of 18 °C to 30 °C. The formulation is 98.0 wt% to 99.0 wt% neat resin plus 1.0 wt% to 2.0 wt% colour masterbatch on a homopolymer carrier; white cassette shells use 1.5 wt% to 3.0 wt% titanium dioxide masterbatch, which raises melt viscosity and requires injection speed increases of 10% to 20% to maintain fill without burn marks. Compliance is assessed under IVDR 2017/746, ISO 13485:2016, ISO 15223-1:2021, FDA 21 CFR 177.1520(c), and ISO 10993-5:2009. Flatness across a 60 mm cassette body is maintained within 0.1 mm using valve-gated cold-runner drops of 0.8 mm diameter and ejection below 55 °C surface temperature. On twin-platen machines, micro-flash appears at the cassette interface when clamp force is below 140 t for 32-cavity tools; the defect is eliminated when clamp force is raised to 160 t to 200 t and mould alignment is verified to ±0.02 mm. End products include lateral-flow antigen test cassette shells, buffer cap closures, and reader tray adapters.
| Processing variable | Thin-wall diagnostics | Syringe barrels and plungers | Spunbond nonwoven medical apparel |
|---|---|---|---|
| Melt temperature | 230 °C–250 °C | 225 °C–245 °C | 230 °C–250 °C |
| Tool/roll temperature | 20 °C–40 °C | 8 °C–20 °C | 145 °C–160 °C calender |
| Speed parameter | 150 mm/s–300 mm/s injection | 120 mm/s–250 mm/s injection | 10 g/m²–50 g/m² basis weight output |
| Pressure parameter | 600 bar–1,000 bar hold | 500 bar–900 bar hold | 50 N/mm–80 N/mm nip |
| Wall thickness or fibre web mass | 0.4 mm–1.2 mm | 1.5 mm–2.5 mm | 10 g/m²–50 g/m² |
| Critical upper threshold | Warpage 0.3 mm across diagonal | Yellowness index shift 4 units post-irradiation | Calender temperature 160 °C causing fibre flattening |
Laboratory centrifuge tubes of 15 mL and 50 mL nominal capacity are injection moulded from H0500HN with wall thickness from 1.0 mm to 1.6 mm. The melt is kept at 220 °C to 240 °C, the mould at 10 °C to 25 °C, and hold pressure at 500 bar to 800 bar. Because the homopolymer melt has a steep pressure-dependent viscosity response, non-return valve leakage above 0.5 mm stroke produces shot-to-shot weight variation exceeding 0.05 g, which appears as flash at the tube rim or sink marks opposite the bottom gate. The formulation is 99.0 wt% to 99.9 wt% H0500HN with 0.05 wt% to 0.15 wt% nucleating agent and 0.10 wt% to 0.20 wt% antistatic masterbatch; slip additives are avoided where tube labels must remain adhered after hot-fill contact. Compliance follows ISO 13485:2016, IEC 61010-2-101, FDA 21 CFR 177.1520(c), and ISO 10993-5:2009. Autoclave resistance is bounded: unfilled homopolymer PP distorts above 121 °C, so standard laboratory protocols restrict exposure to 15 min at 121 °C or 20 min at 115 °C unless the tube design includes a thicker collar and additional support. End products include 15 mL and 50 mL conical centrifuge tubes, flat-bottom culture tubes, and screw-cap adapters.
Where H0500HN is evaluated on spunbond nonwoven lines producing single-layer fabrics for medical caps, shoe covers, and isolation gown segments, the melt delivery system is set between 230 °C and 250 °C, spin-pack pressure is maintained below 150 bar, and melt pump throughput is adjusted to a basis weight of 10 g/m² to 50 g/m². Calender rolls are heated to 145 °C to 160 °C with nip pressure from 50 N/mm to 80 N/mm; above 160 °C, fibre flattening reduces air permeability below 200 L/m²/s at 200 Pa per EN ISO 9237:1995, producing a denser web that may breach breathability expectations for gowns. The formulation is 98.0 wt% to 99.5 wt% H0500HN and 0.5 wt% to 2.0 wt% colour masterbatch; where antistatic or hydrophilic concentrate is required, addition up to 3.0 wt% is accepted only after spin-pack pressure remains below 180 bar and fibre-diameter distribution stays within 15 μm to 25 μm as measured by optical microscopy. Compliance for medical apparel is assessed under EN 13795-1:2019, AAMI PB70:2012, ISO 13688:2013, and FDA 21 CFR 177.1520(c); biological evaluation follows ISO 10993-5:2009 and ISO 10993-10:2010 for skin contact. Published data specific to H0500HN in spunbond equipment is limited; the processing envelope above reflects standard industrial practice for controlled-rheology PP homopolymers in the same fluidity band. End products include nonwoven surgical caps, shoe covers, isolation gowns, and outer face-mask layers.
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MedSelect PP Homopolymer H0500HN is a polypropylene homopolymer grade directed toward injection-moulded single-use medical device components. The designation carries an inferred nominal melt flow rate of 5.0 g/10 min under ISO 1133-1:2022 conditions of 230 °C and 2.16 kg, while the HN suffix is typically interpreted as high nucleation in supplier nomenclature. These nomenclature interpretations are not a substitute for the technical data sheet and lot certificate. Published data for this specific configuration is limited; therefore, the mechanical, rheological, and regulatory envelope described below uses the class boundaries for nucleated medical-grade polypropylene homopolymers at this flow range. The grade is evaluated for components in contact with pharmaceutical fluids, diagnostic reagents, and bodily fluids when supported by ISO 10993-1:2018 biological evaluation and USP <661.1> plastic packaging testing. As a homopolymer, the material contains no intentional ethylene comonomer and is differentiated from random copolymers by higher crystallinity, higher flexural modulus, lower clarity, and reduced low-temperature impact resistance.
The main structural difference is comonomer content. Random copolymers typically incorporate 1 wt% to 8 wt% ethylene, which disrupts isotactic polypropylene crystallinity and shifts the ductile-brittle transition to lower temperatures. H0500HN as a homopolymer retains a higher crystallinity, measured indirectly by density in the range 0.900 g/cm³ to 0.910 g/cm³ under ISO 1183-1:2019. Clarified homopolymers use sorbitol-based clarifiers to increase contact transparency and may achieve haze below 10 % in 2 mm plaques, while non-clarified nucleated homopolymers remain translucent. The presence of a nucleating agent in H0500HN should be confirmed from the certificate of analysis because HN does not govern optical properties in the same manner as a clarifier grade. In automated diagnostic cartridges, the chief trade-off is between rigidity and impact tolerance at freezer storage temperatures.
| Property | Test method | H0500HN class | Random copolymer class | Clarified homopolymer class |
|---|---|---|---|---|
| Density | ISO 1183-1:2019 | 0.900–0.910 g/cm³ | 0.890–0.905 g/cm³ | 0.900–0.910 g/cm³ |
| Tensile yield stress | ISO 527-2:2012 | 30–38 MPa | 22–30 MPa | 32–40 MPa |
| Flexural modulus | ISO 178:2019 | 1200–1700 MPa | 700–1200 MPa | 1300–1800 MPa |
| Notched Izod impact at 23 °C | ISO 180/A | 2.0–4.0 kJ/m² | 6.0–15.0 kJ/m² | 2.0–4.5 kJ/m² |
These class boundaries illustrate why H0500HN is generally not interchangeable with random copolymer in applications requiring impact at -20 °C. The homopolymer serves where stiffness, dimensional stability, and creep resistance at ambient temperature override optical clarity. In contrast, clarified homopolymers offer high rigidity and reduced haze but may require higher processing temperatures due to clarifier shear sensitivity. Mould shrinkage also differs. Homopolymer PP typically exhibits mould shrinkage of 1.2 % to 1.6 %, while random copolymer may be 1.0 % to 1.4 % under ISO 294-4:2018. Tooling must be cut accordingly. Nucleated homopolymer can reduce post-moulding dimensional movement because crystallisation is faster and more uniform. However, the exact shrinkage of H0500HN should be measured on a cavity-matched test bar.
On production-scale injection moulding machines with 20:1 to 24:1 L/D three-zone general-purpose screws, the material should be processed at a melt temperature of 220 °C to 250 °C and a mould temperature of 20 °C to 60 °C. Lower mould temperatures are used where cycle-time reduction and dimensional control dominate; higher mould temperatures improve crystallinity and reduce moulded-in stress. When relative humidity in the storage or transfer environment exceeds 60 %, surface moisture should be removed by desiccant drying at 80 °C for 2 h to 4 h. Polypropylene homopolymer is not hygroscopic, but condensed moisture on cold granules entering the feed throat causes surface splay and inconsistent shot weight.
The critical processing conflict arises in thin-wall sections below 0.6 mm. At a nominal melt flow rate of 5.0 g/10 min, the process window can narrow to ±5 °C. Below the lower limit, short shots and flow hesitation marks appear because the melt front solidifies before cavity filling is complete. Above the upper limit, degradation accelerates and may produce gate blush, yellowing, and an increase in low-molecular-weight extractables. High-speed injection units with injection velocities of 200 mm/s to 400 mm/s are typically used for multi-cavity pipette-tip or cartridge tools; insufficient velocity is observed as non-uniform filling of end cavities. Hot-runner manifolds should be held at 230 °C to 250 °C, and the total residence time at full melt temperature should not exceed 5 min. Gate geometry affects shear heating; a nucleated grade can crystallise rapidly at elevated temperatures, reducing cycle time but increasing risk of gate-stringing if the gate is oversized.
Single-cavity medical device housings are moulded with clamp forces determined by projected area rather than by an absolute grade requirement. The injection pressure needed to fill a 1.0 mm wall section is routinely 80 MPa to 120 MPa; thinner sections can require the upper end or exceed it. In very fast cycles, accumulator-assisted hydraulics or electric injection units with sufficient screw recovery for the shot volume prevent feed-throat blockage. Failure patterns observed on medical moulding lines include interrupted screw recovery when back pressure is below 5 bar, gate blush when the hot drop exceeds 280 °C, and warpage when mould temperature varies by more than 10 °C across the cavity.
Gamma sterilisation of polypropylene homopolymer is controlled by radiation dose, dose rate, oxygen ingress, and the antioxidant package. At 25 kGy to 50 kGy, the polymer backbone undergoes chain scission and oxidative degradation that lowers elongation at break and notched impact resistance. In unstabilised homopolymer PP, retained elongation at break after 25 kGy can fall below 50 % of the unexposed value; a stabilised medical grade is intended to reduce this loss but not eliminate it. The manufacturer’s irradiation certificate should be reviewed for maximum cumulative dose. Components receiving multiple sterilisation exposures may embrittle beyond the acceptable design margin.
Electron-beam sterilisation at similar doses can produce less oxidative damage when oxygen diffusion is limited, but the short exposure time does not remove the need for post-irradiation property validation. Autoclave sterilisation at 121 °C or 134 °C may be constrained by the heat deflection temperature of 80 °C to 95 °C under ISO 75-2/B; parts under load can deform. Ethylene oxide sterilisation is often performed below 55 °C, but residual gas and humidity conditions must be validated. The grade may be acceptable for one sterilisation method and not another because stabiliser consumption differs under each condition. For this reason, a single sterilisation compatibility statement without a stated dose, method, and maximum repeat count is insufficient for regulatory review.
In liquid-handling consumables such as pipette tips and microtitre plates, the flexural modulus of 1,200 MPa to 1,700 MPa provides the rigidity required for ejection and stacking. Automated pipetting systems such as 96-channel air-displacement liquid handlers impose repeated axial ejection forces; excessive flexibility causes tip-to-tip dimensional scatter, while excessive brittleness causes cracking at the ejector boss. The grade is dimensionally stable in aqueous and polar reagent environments because the saturated hydrocarbon backbone has very low moisture absorption, typically below 0.03 % under ISO 62:2008. This low water uptake reduces the risk of hydrolytic degradation and supports consistent dimensions in humidity-controlled diagnostic instruments.
The primary limitation is low-temperature impact. Polypropylene homopolymer exhibits a ductile-brittle transition that can occur between 0 °C and 10 °C, depending on molecular weight, nucleating agents, and part geometry. Components intended for storage at -20 °C or -80 °C should be evaluated under ISO 179-1/1eA or ISO 180/A notch impact conditions before conversion. In cryovial caps and freezer-stored diagnostic cartridges, this limitation may require replacement with a random copolymer or an impact-modified grade. Conversely, for room-temperature centrifuge-tube caps and diagnostic housings, the higher modulus and lower creep of the H0500HN class homopolymer is mechanically useful.
Creep resistance under low static load is controlled by crystallinity and temperature. At 23 °C and a stress below 25 % of the yield stress, dimensional change over 24 h is typically small; above 50 % of yield, creep is significant and can affect cap sealing pressure. These limits are not product-specific constants and should be confirmed by application-specific testing.
Medical-device manufacturers should obtain a full technical data sheet, lot certificate, change-control commitment, and biocompatibility statement from the supplier. The following standards constitute a typical documentation set for a medical polypropylene homopolymer grade. Inclusion in this list is not a regulatory clearance for any specific component.
| Regulatory/standard area | Designation | Typical data required |
|---|---|---|
| US FDA food-contact polypropylene | 21 CFR 177.1520 | monomer specification, olefin content, extraction tests if applicable |
| Plastic packaging physicochemical testing | USP <661.1> | physicochemical profile of plastic material of construction |
| Biological evaluation | ISO 10993-1:2018 | cytotoxicity, sensitisation, irritation, and systemic endpoints depending on contact duration |
| Extractables testing | ISO 10993-18:2020 | GC-MS, LC-MS, ICP/MS semi-quantitative extractables under exaggerated solvent conditions |
| Elemental impurities | USP <232>, <233> | ICP/MS method validation and limits for elements |
| Restricted substances | REACH Regulation 1907/2006 | SVHC declaration, Annex XVII restrictions |
| RoHS | Directive 2011/65/EU | lead, mercury, cadmium, hexavalent chromium, PBB, PBDE limits |
Material substitution without revalidation is not acceptable. Lot-to-lot viscosity shifts should be monitored by ISO 1133-1:2022 melt flow rate and ISO 3146:2022 melting temperature. If the supplier changes the nucleating package, additive package, or polymerisation site, the change notification should trigger a repeat of ISO 10993-18:2020 extractables and ISO 10993-1:2018 biological endpoint screening as required by the device risk file. The material should also be processed under established cleaning, drying, and regrind-control procedures. Use of regrind in medical components is permitted only when allowed by the supplier and validated for the specific device; regrind levels above 20 % in unfilled PP may alter flow and impact properties and should not be assumed interchangeable with virgin granulate.
