| HS Code | 394705 |
| Product | MedSelect PP Homopolymer P9M7R-056 |
| Material | Polypropylene Homopolymer |
| Density | 0.902 g/cm³ |
| Melt Flow Rate | 25 g/10 min at 230°C/2.16 kg |
| Tensile Strength At Yield | 35 MPa |
| Elongation At Yield | 12% |
| Elongation At Break | 50% |
| Flexural Modulus | 1400 MPa |
| Izod Impact Notched At 23 C | 30 J/m |
| Rockwell Hardness | R100 |
| Heat Deflection Temperature At 0 45 Mpa | 105 °C |
| Vicat Softening Temperature | 150 °C |
| Mold Shrinkage | 1.3% |
As an accredited MedSelect PP Homopolymer P9M7R-056 factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | MedSelect PP Homopolymer P9M7R-056 is supplied in 25 kg polyethylene-lined bags, palletized and stretch-wrapped for protection. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with MedSelect PP Homopolymer P9M7R-056, secured in packaging, ready for safe transport. |
| Shipping | MedSelect PP Homopolymer P9M7R-056 ships as a non-hazardous thermoplastic resin. It is packed in sealed polyethylene-lined bags or Gaylord boxes to prevent contamination and moisture uptake. Transport via covered trailers or containers, keeping dry and away from heat sources. Avoid prolonged storage above 40°C to preserve material properties. |
| Storage | Store MedSelect PP Homopolymer P9M7R-056 in a cool, dry, well-ventilated area away from direct sunlight, heat sources, and open flames. Keep containers tightly sealed to prevent moisture contamination and dust ingress. Maintain temperatures below 40°C where possible. Avoid prolonged exposure to UV light. Ensure proper labeling and handle with care to preserve material integrity and safety. |
| Shelf Life | Shelf life is indefinite when stored in original, unopened packaging away from heat, moisture, and direct sunlight. |
In cold-runner injection molding of thin-wall medical waste cups and specimen transport containers, MedSelect PP Homopolymer P9M7R-056 is typically maintained between 230°C and 250°C, with a measured hot-runner nozzle temperature no more than 10°C above the rear zone set point. The mold surface temperature is held between 20°C and 50°C, and the filling phase uses an injection velocity of 150 mm/s to 300 mm/s when the flow-length-to-wall-thickness ratio exceeds 150:1. For a 16-cavity cold-runner mold producing a cup with a 0.5 mm nominal sidewall and an 85 mm flow path, the required hydraulic clamp force is typically between 100 t and 150 t, depending on the projected area and gate pressure. Because the grade designation suffix -056 is conventionally read as a nominal melt flow rate near 56 g/10 min under ISO 1133-1:2022 conditions of 230°C and 2.16 kg, the pressure drop across a 0.5 mm wall section remains low enough to prevent premature freeze-off at the end of fill. Batch-to-batch variation in melt viscosity should be monitored using ASTM D1238-20, and the supplier’s lot-specific certificate should be checked before setting the switch-over position. Pre-drying at 80°C for 2 h is implemented only if moisture content exceeds 0.05 wt%, because polypropylene is not hygroscopic but surface condensation from cold storage can create splay. Compliance for medical packaging under USP <661.1> and extractables evaluation under ISO 10993-18:2020 requires that the processing stabilizer package not be exceeded by the addition of reground material above 20 wt%, because repeated high-shear processing can consume the primary antioxidant and enlarge the low-molecular-weight extractable fraction.
| Property | Test Standard | Typical Range for PP Homopolymer |
|---|---|---|
| Melt flow rate | ISO 1133-1:2022 | 50–60 g/10 min at 230°C/2.16 kg |
| Density | ASTM D792-20 | 0.900–0.910 g/cm³ |
| Tensile yield stress | ASTM D638-14 | 30–36 MPa |
| Flexural modulus | ASTM D790-17 | 1300–1600 MPa |
| Notched Izod impact at 23°C | ASTM D256-10(2018) | 2.0–5.0 kJ/m² |
| Heat deflection temperature at 0.455 MPa | ASTM D648-18 | 90–105°C |
| Mold shrinkage | ASTM D955-21 | 1.0–1.6% |
Steam sterilization at 121°C and 15 psi for 30 min per cycle imposes oxidative load on the surface and gate region of a thin-wall syringe barrel. The limiting factor is usually not short-term heat deflection, because the heat deflection temperature under 0.455 MPa load is between 90°C and 105°C when measured by ASTM D648-18, but the progressive consumption of processing antioxidants at the surface. A 32-cavity valve-gated hot runner with individual nozzle shut-off is typically used, and the barrel wall section of 0.35 mm to 0.60 mm requires a clamp force of 150 t to 200 t to compensate for the high flow length. When retention of impact is critical, the notched Izod impact should be measured per ASTM D256-10(2018) before and after 25, 50, and 100 cycles; if the value falls below 3.0 kJ/m² at 23°C, rejection of the cavity set or replacement of the resin lot is typically required. Ethylene oxide sterilization at 55°C with a 6 h aeration phase is generally less aggressive than steam, but residuals must be checked by ISO 10993-7:2008. If the exact number of autoclave cycles must be guaranteed for regulatory submission, published data for this specific configuration is limited, and lot-specific aging studies should be performed on molded parts rather than on pellets alone.
Extrusion of sheet from this high-flow grade requires roll-stack temperatures between 70°C and 90°C when the sheet thickness is 0.3 mm to 1.2 mm. The extruder should be a single-screw unit with an L/D ratio of 30:1 to 36:1, a barrier screw, and a screen pack of 60/80/100 mesh to remove agglomerates without generating excessive shear heating. Melt temperature at the die lip is limited to 220°C to 240°C, and the die gap is set 10% to 20% wider than the target sheet thickness to control orientation. During plug-assist thermoforming, the plug temperature is held between 110°C and 125°C, and the mold surface temperature is maintained between 20°C and 40°C; the heated sheet surface should reach 155°C to 165°C before forming. Failure to maintain the upper sheet temperature below 165°C causes sag and thickness variation, especially at a sheet width greater than 600 mm. Finished thin-wall food trays and blister packs should be evaluated for tensile yield stress by ASTM D638-14, thickness uniformity by ASTM D5947-18, and overall migration under EU No 10/2011 at 70°C for 2 h or 40°C for 10 days.
On continuous compression molding and injection molding lines for beverage and dairy closures, the high melt flow of 56 g/10 min shortens cycle time but requires precise hold-pressure decay. The recommended holding pressure is 30% to 50% of peak injection pressure, and the holding time is limited to 0.5 s to 1.0 s per millimetre of nominal wall thickness to avoid overpacking. Removal torque is recorded with a calibrated digital torque tester using a fixture conforming to the neck finish drawing; typical release torque values for a 28 mm still water finish range from 0.5 N·m to 2.5 N·m, but the acceptable band is set by the filling-line capping head, not by the resin. Homopolymer PP closures exhibit lower environmental stress-cracking resistance than impact-modified PP; contact with fats, essential oils, or non-ionic surfactants above 40°C should be qualified by a 48 h ESC immersion test at 60°C before production release. This grade is not recommended for carbonated soft drink closures with PCO 1881 finish unless an impact modifier is incorporated, because the homopolymer PP exhibits brittle failure in notched Izod impact tests at 4°C according to ASTM D256-10(2018). Dimensional stability after 24 h at 23°C and 50% RH should be confirmed by measuring closure inner diameter with a calibrated plug gauge; the allowable mold shrinkage range is typically 1.0% to 1.6% as determined by ASTM D955-21, and any value outside this band requires review of the cooling channel layout or cycle timer.
If this high-flow grade is introduced into a spunbond line originally configured for a 25 MFR polypropylene, the extruder temperature profile must be reduced from 230°C to 210°C in the melting zone and the spin-beam temperature trimmed to 195°C to 215°C. The lower die swell at the spinneret requires the capillary shear rate to be kept between 3000 s⁻¹ and 6000 s⁻¹ to avoid droplet breakup and fiber diameter nonuniformity. Filament draw is controlled by a quench air temperature of 10°C to 18°C and a draw jet pressure of 0.6 bar to 1.2 bar; these parameters influence nonwoven tensile strength measured by ISO 9073-3:1989 and elongation measured by ISO 9073-2:1995. Bonding roll temperatures normally range from 135°C to 155°C with a nip pressure of 30 N/mm to 80 N/mm; calender roll speed differentials above 2% should be avoided because high-flow homopolymer PP develops surface defects at the embossed point. A brittle point below 0°C is observed in finished fabric because the base resin is a homopolymer, and therefore cold-temperature flex cracking should be assessed by ISO 7854:1995 if the nonwoven is intended for cold-chain packaging. Additives for ultraviolet stabilization are limited to 0.10 wt% to 0.30 wt% of a high-molecular-weight hindered amine stabilizer, while hydrophilic wetting agents should not exceed 0.20 wt% of the compound to avoid migrating species that raise the nonwoven extractable level under ISO 10993-12:2021.
When used as a carrier resin for 40% to 60% pigment or additive masterbatch, the grade is processed on a co-rotating twin-screw extruder with an L/D ratio of 40:1 to 48:1, a screw speed of 600 rpm to 900 rpm, and a melt temperature not exceeding 240°C, because the high MFI provides rapid wetting of fillers but short residence time is required to avoid thermo-oxidative chain scission.
Petri dishes, microcentrifuge tubes, and serological pipette bodies molded from this grade are commonly tested under USP <661.1> and ISO 10993-12:2021 for total organic carbon and UV absorbance after extraction in water at 121°C for 1 h. The homopolymer PP backbone has minimal UV-absorbing leachables, but the antioxidant and acid-neutralizer packages must be controlled; a typical primary antioxidant loading of 0.05 wt% to 0.15 wt% and an acid scavenger loading below 0.10 wt% are used to keep total organic carbon below 0.5 mg/L in the aqueous extract. Autoclave performance at 121°C is acceptable for polypropylene because the melting region begins above 160°C; however, dry-heat sterilization above 160°C should not be used because localized melting and warpage occur. Dimensional checks after autoclaving should follow the mold shrinkage measurement method of ASTM D955-21; a change in part length greater than 0.5% between pre- and post-autoclave measurements indicates insufficient cooling time or excessive orientation in the gate area. For in-vitro cytotoxicity evaluation, the finished device is extracted in minimum essential medium at 37°C for 24 h, and the test is conducted according to ISO 10993-5:2009; no more than 20% regrind is recommended without revalidation of the extractables profile. Combination with copper-based or pro-oxidant additives is incompatible with medical packaging because these species accelerate oxidative chain scission.
| Standard | Test Condition | Acceptance Criterion |
|---|---|---|
| FDA 21 CFR 177.1520 | Food-contact olefin polymer | Conforms to extractable limits for PP homopolymer |
| USP <661.1> | Plastic packaging for medical use | Total organic carbon < 0.5 mg/L |
| ISO 10993-5:2009 | MEM extraction, 37°C, 24 h | No greater than Grade 2 cytotoxicity |
| ISO 10993-10:2010 | Intracutaneous reactivity | No erythema or edema above score 1 |
| EU No 10/2011 | Overall migration, 40°C, 10 days or 70°C, 2 h | < 10 mg/dm² |
| REACH (EC) No 1907/2006 | SVHC screening | No SVHC above 0.1 wt% |
| RoHS 2011/65/EU | XRF screening | Pb, Hg, Cd, Cr(VI), PBB, PBDE < 1000 ppm |
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MedSelect PP Homopolymer P9M7R-056 is a medical-segment polypropylene homopolymer supplied as pelletized resin for injection molding and extrusion of components requiring reduced additive burden, structural stiffness, and controlled melt-viscosity behavior. The grade belongs to the isotactic polypropylene family, with a crystalline fraction typically between 45% and 60% when measured by differential scanning calorimetry according to ISO 11357-3:2018. Because the formulation is directed to pharmaceutical and diagnostic applications, the additive package is restricted to substances with documented regulatory clearance under Ph. Eur. 3.1.3, USP <661.1>, and FDA 21 CFR 177.1520 for olefin polymers. The designation P9M7R-056 is a manufacturer-specific commercial identifier; no independent peer-reviewed data set for this exact configuration was identified at the time of writing. Its conformance is controlled through certificate-of-analysis reporting of melt mass-flow rate, tensile properties, impurity content, and extractive profiles. The absence of ethylene comonomer distinguishes P9M7R-056 from random and impact copolymers by preserving higher flexural modulus and a narrower melting range, while reducing low-temperature impact strength. In medical device production, this trade-off is applied to rigid housings, specimen containers, pipette tips, and diagnostic cassettes where dimensional stability after autoclaving or gamma irradiation is prioritized over impact toughness.
Incoming resin qualification for P9M7R-056 is centered on melt mass-flow rate, tensile modulus, yield stress, and xylene-soluble content. Melt flow rate is determined under ISO 1133-1:2022 at 230 °C with a 2.16 kg load. Medical polypropylene homopolymers in thin-wall applications commonly span 10 g/10 min to 40 g/10 min; lot-specific P9M7R-056 values are stated in the certificate of analysis rather than in generic literature. Tensile properties are characterized on injection-molded Type 1A specimens using ISO 527-2:2012; unfilled homopolymers of this class typically exhibit yield stress from 30 MPa to 38 MPa and tensile modulus from 1.3 GPa to 1.8 GPa at 23 °C. Flexural modulus measured according to ISO 178:2019 generally falls between 1.2 GPa and 1.6 GPa. Notched Charpy impact strength under ISO 179-1:2020 is normally below 5 kJ/m² at 23 °C, reflecting the brittle failure mechanism of high-isotacticity homopolymer. Haze and transmittance data are relevant for diagnostic components; unfilled homopolymer grades without clarifying agent typically show haze above 15% on 2 mm plaques under ISO 14782:2021 or ASTM D1003-21. The xylene-soluble fraction, approximating atactic and low-molecular-weight content, should remain below 6% by mass for cleanliness-sensitive medical applications; the exact P9M7R-056 specification is manufacturer-controlled.
Processing of P9M7R-056 on twin-screw compounding lines is performed with co-rotating extruders having 25:1 to 44:1 L/D ratios. Barrel temperatures between 180 °C and 230 °C are common for dispersion of the limited additive package; screw configurations with at least 2 kneading blocks distribute heat and minimize low-molecular-weight gel formation. On injection molding machines with clamping forces from 50 t to 250 t, the typical melt temperature window for unfilled medical polypropylene homopolymers lies between 200 °C and 250 °C; a narrower verified window for P9M7R-056 is supplied in processing documents. Injection pressures between 70 MPa and 120 MPa, with hold pressures at 50% to 70% of peak, reduce sink marks in rigid diagnostic parts. The screw cushion should remain between 3 mm and 6 mm to avoid residence-time variation. Excessive residence time above 15 min at melt temperatures above 260 °C initiates chain scission of polypropylene; the resulting increase in melt flow rate and yellowing are irreversible. Purging after production interruptions uses a low-MFR polypropylene to avoid cross-contamination between P9M7R-056 and other resin families. Moisture content is not a major processing variable because polypropylene homopolymer uptake at 23 °C and 50% RH is typically less than 0.02% under ISO 62:2008; pre-drying is required only when surface condensation forms during warehouse transitions from cold storage to ambient production areas.
The response of P9M7R-056 to ionizing radiation is governed by free-radical chain chemistry. Sterilization doses of 25 kGy to 50 kGy under ISO 11137-1:2006/Amd 1:2013 generate alkyl radicals that participate in beta-scission, reducing number-average molecular weight and increasing melt flow rate. The magnitude of the shift depends on dose rate, oxygen diffusion, and process stabilizer availability. For unfilled polypropylene homopolymers, melt flow rate can increase by 20% to 60% after a single sterilizing dose in air at ambient temperature, but published data for P9M7R-056 at specific doses is limited to the manufacturer’s radiation validation file. Elongation at break is more sensitive than tensile yield stress; elongation at break sometimes falls from above 50% to below 20% after irradiation in additive-minimized grades. Radiation-stabilized package validation under ISO 11607-1:2019 for terminally sterilized medical devices therefore requires post-irradiation testing of the sealed component. If the device is sterilized by autoclave at 121 °C for 30 min under ISO 17665-1:2006, polypropylene homopolymer maintains stiffness better than random copolymer because the higher crystalline fraction resists heat collapse, although steam penetration can promote surface hydrolysis of additive residues. For either sterilization mode, the extraction profile should be confirmed on the finished device using ISO 10993-12:2021 and ISO 10993-18:2020.
P9M7R-056 differs from other medical polypropylene grades in comonomer content, optical behavior, and low-temperature performance. Random copolymers contain 2 wt% to 10 wt% ethylene, which depresses the melting peak from the homopolymer range of 160 °C to 165 °C to approximately 130 °C to 148 °C under ISO 11357-3:2018; the lower melting temperature improves seal initiation but reduces autoclave dimensional stability. Impact copolymers introduce a dispersed ethylene-propylene rubber phase that raises notched Charpy values above 10 kJ/m² at 23 °C but creates higher haze and a second melt peak. Clarified homopolymers use nucleating or clarifying additives to reduce haze to below 10% at 2 mm; P9M7R-056 is not represented as a high-clarity grade unless a clarifying package is explicitly declared in the certificate of analysis. Compared with high-flow homopolymers designated for thin-wall packaging, P9M7R-056 is expected to preserve higher melt strength and lower MFR drift during repeated processing because chain scission is minimized by the additive formulation. The exact placement of P9M7R-056 within these property envelopes must be verified against lot-specific data, since homopolymer grades with identical MFR can differ in isotacticity, molecular weight distribution, and nucleating agent content.
| Property | Test Standard | Unfilled PP Homopolymer | Random Copolymer |
|---|---|---|---|
| Melt mass-flow rate | ISO 1133-1:2022 | 10–40 g/10 min at 230 °C/2.16 kg | 1–50 g/10 min at 230 °C/2.16 kg |
| Tensile modulus | ISO 527-2:2012 | 1.3–1.8 GPa | 0.9–1.3 GPa |
| Notched Charpy impact | ISO 179-1:2020 | 2–5 kJ/m² at 23 °C | 6–20 kJ/m² at 23 °C |
| Melting peak | ISO 11357-3:2018 | 160–165 °C | 130–148 °C |
Chemical resistance of P9M7R-056 is assessed by immersion under ISO 175:2010 or ASTM D543-21. Polypropylene homopolymer remains unaffected by many dilute mineral acids, alkaline solutions, and saline, but is attacked by strong oxidizing agents such as concentrated nitric acid, halogens, and some organic solvents that swell the amorphous phase. For medical device submission, extractables data are generated by exhaustive extraction on the final device using ISO 10993-12:2021 with polar and nonpolar solvents. The extract profile is then quantified by chromatographic methods under ISO 10993-18:2020. Because P9M7R-056 is an additive-minimized grade, the target is a reduced level of phenolic antioxidants and phosphate process stabilizers relative to general-purpose extrusion grades; however, complete absence of additives may compromise melt stability during high-shear molding. The operational boundary for this grade is therefore not resistance to common aqueous reagents but retention of low extractables after terminal sterilization and accelerated aging. If components are used with alcohols above 60% concentration or lipid-containing formulations, compatibility should be verified under simulated use conditions specified in ISO 10993-13:2010 for polymer degradation products. No grade-specific published extractables database for P9M7R-056 was identified at the time of writing.
Gate and runner dimensions for P9M7R-056 are sized for high-pressure flow into thin-wall cavities. The recommended mold temperature is generally 20 °C to 60 °C; higher mold temperatures increase crystallinity and may reduce cycle time through faster crystallization but also increase shrinkage. Linear mold shrinkage for unfilled polypropylene homopolymer ranges from 1.0% to 2.0% in flow and transverse directions; tool design should use separate shrink factors because orientation-induced anisotropy is higher than in random copolymers. Hot runner systems with external heating and unobstructed flow paths reduce dead spots that cause yellowing. For diagnostic parts with flat optical windows, diaphragm gating or fan gating promotes radial flow and reduces visible knit lines, but P9M7R-056 is not an optically clarified product unless the certificate confirms a nucleating package.
P9M7R-056, when processed on single-screw extruders, requires a 3-zone screw with a compression ratio from 2.5:1 to 3.5:1 and a feed depth matched to pellet bulk density. Barrier screws are preferred for medical-grade output because they separate solids from melt, reducing the probability of partially melted granules reaching the metering zone. At screw speeds above 100 min⁻¹ on a 45 mm extruder, shear heating from the compression zone can exceed the barrel set point; melt-temperature feedback control should override barrel set points to prevent localized oxidation. Screen packs with 60/80/100 mesh layers are used downstream of the breaker plate to capture agglomerated additives; pressure drop across the screen must not exceed 20 MPa at the extruder head. Frequent screen changes are required if the feedstock contains fines from regrind because the resulting pressure fluctuations disturb pellet homogeneity. The purge protocol after processing P9M7R-056 should use a homopolymer with similar MFR, not a random copolymer, to avoid rheological incompatibility and the formation of interface gels in the die channel.
Steam sterilization of P9M7R-056 devices is validated at 121 °C for 30 min or 134 °C for 5 min under ISO 17665-1:2006; the higher temperature cycle shortens exposure but narrows the safety margin against thermal distortion. Seal initiation for homopolymer packaging occurs at higher temperatures than random copolymer packaging, typically above 150 °C, and seal strength is measured on 15 mm wide strips pulled at 100 mm/min to 300 mm/min under ASTM F88/F88M-21. Because migration kinetics are a function of molecular mobility in the amorphous phase, the higher crystallinity of P9M7R-056 reduces the diffusion coefficient for low-molecular-weight additives compared with random copolymers; this is an advantage for low extractables but a limitation for heat-sealing at low temperatures. Avoid compounding P9M7R-056 with amine-based antistatic additives that can generate nitrosamines or increase extractables; transition metal additives should also be excluded unless oxidative stability and color stability are revalidated under ISO 188:2011 or ASTM D3012-19.
| Regulatory Reference | Parameter | Application Requirement |
|---|---|---|
| FDA 21 CFR 177.1520 | Olefin polymers for food contact | Density, melting point, and extraction limits defined by the regulation |
| Ph. Eur. 3.1.3 | Polyolefins for pharmaceutical use | Heavy metals, sulfated ash, and extractables limits |
| USP <661.1> | Plastic packaging systems | Biological reactivity and physicochemical tests |
| ISO 10993-1:2018 | Biological evaluation of medical devices | Risk-based testing category by contact duration and invasiveness |
| REACH (EC) 1907/2006 | Substances of very high concern | Restricted additives only |
| RoHS Directive 2011/65/EU | Restricted heavy metals and brominated flame retardants | Pb, Cd, Hg, Cr(VI), PBBs, PBDEs limits |
The low-temperature operating boundary for P9M7R-056 is influenced by the glass transition of the amorphous phase and by the crystallinity level selected during molding. Notched impact values decline sharply near 0 °C; for unfilled homopolymer, transition from ductile to brittle failure can occur above the glass transition because the absence of a rubber phase prevents localized shear yielding. Applications requiring impact resistance at −20 °C should be converted to an impact copolymer, because the homopolymer fracture energy under ISO 179-1:2020 is insufficient for high-energy drop tests typically specified at 1 m or 2 m in package validation protocols. Dimensional stability after aging is evaluated by measuring post-mold shrinkage under ISO 294-4:2018; parts are conditioned for 48 h at 23 °C and 50% RH before metrology. Because polypropylene continues to crystallize at room temperature, final dimensions should be rechecked at 24 h and 48 h intervals; immediate tool qualification can underestimate long-term shrinkage. The coefficient of linear thermal expansion for unfilled homopolymer is typically 80 × 10⁻⁶ K⁻¹ to 110 × 10⁻⁶ K⁻¹ between 23 °C and 80 °C; this value is higher than that of glass-reinforced grades and must be included in mating-component tolerance stacks.
