| HS Code | 576118 |
| Polymertype | High Density Polyethylene (HDPE) |
| Density | 962 kg/m³ |
| Meltflowrate 190c 2 16kg | 21 g/10 min |
| Meltingtemperature | 135 °C |
| Crystallizationtemperature | 118 °C |
| Vicatsofteningtemperature | 128 °C |
| Tensilemodulus | 1500 MPa |
| Tensilestressatyield | 31 MPa |
| Tensilestrainatyield | 9 % |
| Tensilestrainatbreak | 100 % |
| Charpynotchedimpactstrength 23c | 3 kJ/m² |
| Charpyunnotchedimpactstrength 23c | 50 kJ/m² |
| Shoredhardness | 65 |
| Thermalconductivity | 0.4 W/m·K |
| Waterabsorption | <0.01 % |
As an accredited Borealis HDPE HE9621-PH-1 factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Borealis HDPE HE9621-PH-1 is supplied in 25 kg polyethylene bags, usually palletized at 1,375 kg per pallet. |
| Container Loading (20′ FCL) | Borealis HDPE HE9621-PH-1 loaded in a 20′ FCL dry container, palletized 25 kg bags, shrink-wrapped, labeled, and secured for ocean transport. |
| Shipping | Borealis HDPE HE9621-PH-1 is a non-hazardous high-density polyethylene resin, typically shipped as pellets in 25 kg bags, octabins, FIBCs, or bulk containers. It is not classified as dangerous goods for road, rail, sea, or air transport. Keep dry, clean, protected from UV, and handle per SDS. |
| Storage | Store Borealis HDPE HE9621-PH-1 in a cool, dry, well-ventilated area, away from direct sunlight, heat, ignition sources, and strong oxidizers. Keep material in original sealed packaging to prevent moisture, dust, and contamination. Avoid prolonged UV exposure and excessive stacking pressure. Maintain clean handling areas and follow local regulations and supplier recommendations. Do not store outdoors or near incompatible materials. |
| Shelf Life | Shelf life is 2 years when stored unopened in original packaging under dry, cool conditions, protected from direct sunlight and heat. |
On shuttle blow moulding lines with 8-cavity tooling, a 65 mm grooved-feed extruder running at 38–42 rpm, and a 1.2 L accumulator head, Borealis HDPE HE9621-PH-1 is routinely converted into 200 mL oral syrup bottles with a 28 mm finish. The process window for this grade requires barrel temperatures of 180 °C, 185 °C, 190 °C, and 195 °C from feed to metering, with a head and die temperature of 195 °C to 200 °C. A 10-point parison programmer is used to maintain sidewall thickness at 0.7 mm to 0.8 mm while increasing shoulder and base sections to 1.2 mm for top-load stability. Blow air is delivered at 0.6 MPa to 0.7 MPa, mould water is held at 8 °C to 12 °C, and total cycle time is 12 s to 14 s per eight bottles. The compound ratio is 100% virgin Borealis HDPE HE9621-PH-1, with closed-loop recycled tail flash permitted up to 20 wt% when regrind is stored in sealed liners and reintroduced without intermediate drying. If white opacity is specified, a low-migration titanium dioxide masterbatch is added at 2 wt%; slip agents and antistatic additives are excluded because they can reduce cap torque retention and alter the failure mode under child-resistant closure testing.
Top-load resistance measured according to ASTM D2659 at 2 mm/min typically exceeds 180 N for bottles conditioned at 23 °C and 50% RH for 24 h. Drop impact performance after water filling at −5 °C is evaluated by ASTM D2463-15; sidewall cracking rather than base separation indicates excessive parison programming at the pinch-off seam. The finished bottle is filled at ambient temperature because oral syrups containing sucrose or sorbitol are not hot-filled above 40 °C without reducing top-load and raising creep. The terminal product is a 200 mL oral syrup bottle closed with a 28 mm tamper-evident child-resistant closure evaluated to ISO 8317.
| Standard | Scope | Test condition | Acceptance reference |
|---|---|---|---|
| USP 661.2 | Plastic packaging systems for pharmaceutical use | Extraction, leachables, total organic carbon, metals | Monograph-defined limits |
| Ph. Eur. 3.1.3 | Polyolefins | Heavy metals, sulfated ash, acidity/alkalinity | Monograph-defined limits |
| FDA 21 CFR 177.1520 | Olefin polymers for food contact and indirect additives | Extraction in n-hexane and xylene | Conditions of use A–H |
| ASTM D1693-15 | Environmental stress-cracking of ethylene plastics | Condition B, 10% Igepal CO-630, 50 °C | Product-specific ESCR threshold |
| ISO 8317:2015 | Child-resistant packages | Sequential and simultaneous child/adult panel testing | No child access; adult panel ≥ 90% |
| ASTM D2463-15 | Drop impact of blow-moulded containers | 1.2 m drop, −5 °C, filled bottle | No visible crack or fracture |
When a new syrup formulation contains hydroxypropyl methylcellulose or xanthan gum above 0.5 wt%, the filling line backpressure changes, and closure application torque should be revalidated at 1.0 N·m to 1.4 N·m to prevent liner compression set. Flavour extracts based on cinnamaldehyde or eugenol are stress-cracking agents for polyethylene and require ESCR re-screening in the actual product solution at 40 °C for 14 days before production approval.
Rotary injection-blow moulding cells running 12-cavity tooling produce 10 mL ophthalmic squeeze dispensers from Borealis HDPE HE9621-PH-1 without a separate parison transfer step. The preform injection temperature is 200 °C to 220 °C, the core rod is maintained at 105 °C to 120 °C, and the blow mould is held at 15 °C to 18 °C. The formulation is 100% virgin polymer; regrind, slip agents, and colour concentrates are excluded because particulate contamination above 100 µm in eye-drop packaging is unacceptable to routine light obscuration testing. Bottle weight is 7.5 g to 8.5 g, with sidewall distribution held to ±0.05 mm using core rod temperature profiling. The dropper tip orifice is machined to 0.8 mm to deliver a nominal drop volume of 35 µL; the bottle is closed with a tamper-evident LDPE or HDPE cap and a polypropylene closure body. Terminal sterilization by gamma irradiation at 25 kGy to 40 kGy is common, but chain scission in HDPE after 25 kGy can reduce drop impact and neck tensile strength; if gamma is selected, post-sterilization ASTM D2463 drop performance at −5 °C and ASTM D638 neck tensile strength must be rerun. Chemical compatibility screening includes storage in 0.01% w/v benzalkonium chloride at 40 °C for 14 days, evaluated against ASTM D1693 type B, because quaternary ammonium preservatives are known stress-cracking agents for polyethylene. Terminal product: a sterile, low-particulate ophthalmic squeeze dispenser for 10 mL of isotonic or lubricant ophthalmic solution.
At −20 °C, the impact performance of high-density polyethylene shifts toward brittle fracture, and diagnostic reagent bottles that pass ambient drop tests may fail in cold-chain distribution. For 50 mL and 100 mL wide-mouth bottles produced from Borealis HDPE HE9621-PH-1 by continuous extrusion blow moulding with a 4-parison head, the wall thickness is set at 0.8 mm to 1.0 mm, and bottle weight is 15 g to 18 g. The process temperature at the die is 175 °C to 185 °C, blow air is 0.7 MPa, mould water is 10 °C, and cycle time is 8 s to 10 s. The blend is 100% virgin HDPE with 1.5 wt% to 2.0 wt% titanium dioxide masterbatch to provide opacity for light-sensitive reagents; regrind is not permitted when the bottle is intended for lyophilised diagnostic reagents because regrind variability shifts the low-temperature ductile-to-brittle transition. Drop testing is conducted after conditioning filled bottles at −20 °C ± 2 °C for 24 h using ASTM D2463-15 at a drop height of 1.2 m; the acceptance criterion of no visible crack or fracture is combined with a post-drop water leak test under 0.03 MPa internal pressure. Top-load force after cold conditioning is measured by ASTM D2659 and is specified at ≥ 120 N to survive stacked shipping at −20 °C. The terminal product is an opaque white reagent bottle with a 38 mm screw neck for liquid diagnostic buffer or lyophilised reagent transport.
Opaque containers for lipid-soluble nutraceutical formulations are assigned to high-density polyethylene only after permeation screening under ASTM F119 and moisture-vapour transmission measurement under USP 671. Borealis HDPE HE9621-PH-1 bottles of 250 mL, 38 mm neck finish, and 28 g to 30 g weight are produced on shuttle extrusion blow moulders with a 1.2 L accumulator head, die temperature 185 °C to 190 °C, blow air 0.65 MPa, and mould water 10 °C. The material ratio is 98 wt% virgin HE9621-PH-1 and 2 wt% iron oxide/amber masterbatch, with in-house regrind limited to 15 wt% because higher regrind fractions reduce environmental stress-crack resistance and can cause colour shift. The bottle is closed with an induction-sealed foil laminate and a 38 mm child-resistant closure evaluated to ISO 8317. The terminal product is a tight, opaque amber bottle for solid formulations such as vitamin tablets, coated softgels, and powdered herbal blends. The operational boundary is the high permeability of high-density polyethylene to oxygen and most essential-oil components: formulations containing limonene, eugenol, or terpene esters above 2 wt% are not packed in this bottle without fluorinated surface treatment or a secondary foil overwrap, because these compounds plasticise polyethylene and reduce top-load after 30 days at 40 °C. Permeation values reported under ASTM F119 for HDPE containers in this wall-thickness range often show a transmission-rate plateau only after 48 h; published data for this specific configuration is limited, so each new formulation must be screened under 40 °C/75% RH for 12 weeks.
Although high-density polyethylene is generally specified for oral liquid containers, environmental stress cracking in the presence of surfactant-loaded syrups can become the limiting failure mode, particularly at the pinch-off seam and at sharp thread transitions. The controlling test is ASTM D1693-15, Condition B, using 10% v/v Igepal CO-630 in water at 50 °C; virgin injection-moulded specimens of Borealis HDPE HE9621-PH-1 in the 0.960–0.963 g/cm³ density band typically exceed 100 h before 50% of the notched specimens fail, but the same test on bottle sidewall sections with a pinch-off seam may fail in 24 h to 48 h because residual stress from parison welding concentrates tensile load. For a 100 mL oral liquid bottle with 24 mm neck, produced at 180 °C to 195 °C melt temperature and 0.6 MPa blow pressure, stress-crack resistance is improved by increasing the blow-up ratio to 2.0:1 and by maintaining die land length above 12 mm, which reduces frozen-in orientation. The formulation is 100% virgin polymer; reincorporation of tail flash is avoided if the product contains polysorbate 80, sodium lauryl sulfate, or benzalkonium chloride, because regrind shortens crack-initiation time by 10–20% in screening trials. No amine-based antistatic additives or external mould releases are used, as these can migrate to the inner surface and act as crack accelerators in contact with liquid formulations. The finished bottle is capped with a 24 mm tamper-evident LDPE closure and placed in a secondary carton for light protection. If the liquid contains ≥ 0.05 wt% benzalkonium chloride, the product is re-evaluated in actual solution at 40 °C for 14 days because Igepal testing alone does not predict interaction with cationic preservatives.
Packaging lines running continuous extrusion blow moulding with 2-cavity tooling produce 10-tablet effervescent tubes from Borealis HDPE HE9621-PH-1 with a wall thickness of 0.6 mm to 0.8 mm and a tube weight of 6 g to 8 g. The melt temperature at the die is kept at 175 °C to 182 °C, blow air is 0.55 MPa, mould water is 8 °C, and cycle time is 6 s to 8 s. The resin is processed without regrind because tail flash is minimal in this geometry and the product contacts effervescent tablet dust containing citric acid and sodium bicarbonate; moisture ingress through the HDPE wall is controlled by a desiccant cap containing silica gel or molecular sieve. The cap liner must meet USP 661.2 extractables limits, and the assembled tube is tested for moisture vapour transmission under USP 671 at 25 °C/75% RH; weight gain in the desiccant cap after 7 days is used as an incoming control. The terminal product is a 10-tablet effervescent vitamin or analgesic tube, stored in a foil pouch when the commercial shelf life exceeds 12 months. The operational boundary is that HDPE alone does not provide sufficient oxygen or moisture barrier for highly hygroscopic effervescent formulations without the desiccant cap and secondary foil pouch.
Processing trials on a 65 mm, 25 L/D grooved-feed extruder coupled to a single-station shuttle clamp have established a repeatable melt temperature window of 180 °C to 195 °C for Borealis HDPE HE9621-PH-1. Melt pressure at the die is maintained between 250 bar and 350 bar, and extruder screw speed is set at 38 rpm to 42 rpm for 1.2 L accumulator heads. The die gap is programmed from 0.9 mm at the neck to 1.2 mm at the base over 10 parison programming points, while the blow-up ratio is held at 2.0:1 to 2.2:1. Mould cooling water is kept at 8 °C to 12 °C, and internal cooling air at 0.6 MPa is applied for 8 s followed by exhaust cooling for 4 s. Bottles produced under these conditions reach a sidewall thickness of 0.7 mm to 0.8 mm and a top-load value of ≥ 180 N by ASTM D2659. The processing window should be narrowed when the melt temperature exceeds 195 °C because parison sag becomes measurable and wall-thickness reproducibility falls outside ±0.1 mm; below 175 °C, die swell increases and the pinch-off seam becomes more brittle.
| Parameter | Shuttle EBM | Injection-blow moulding | Continuous EBM |
|---|---|---|---|
| Melt temperature | 180–195 °C | 200–220 °C | 175–185 °C |
| Mould temperature | 8–12 °C | 15–18 °C | 10–14 °C |
| Blow pressure | 0.6–0.7 MPa | 0.8–1.0 MPa | 0.6–0.8 MPa |
| Cycle time per 100 mL | 12–14 s | 18–22 s | 8–10 s |
| Regrind permitted | ≤ 20% | 0% | ≤ 15% |
| Typical bottle weight range | 18–30 g | 7–12 g | 10–18 g |
In continuous extrusion blow moulding, the shorter cycle times are achieved at the cost of greater sidewall variation across the parting line, and therefore the continuous route is limited to diagnostic and general-purpose pharmaceutical bottles rather than ophthalmic dispensers where uniform wall thickness controls drop size. In injection-blow moulding, the absence of pinch-off scrap supports 0% regrind operation for ophthalmic and parenteral-adjacent packaging; however, the preform injection phase requires a higher melt temperature than extrusion blow moulding, which narrows the thermal-oxidative window and makes melt filtration through 60 µm breaker plates mandatory. Shuttle extrusion blow moulding remains the highest-output route for oral liquid bottles above 100 mL when top-load specifications exceed 150 N, but the accumulator head must be purged after any shutdown longer than 15 min to avoid crosslinked gel contamination from the high-temperature die zone.
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Borealis HDPE HE9621-PH-1 is a high-density polyethylene grade supplied under the Borealis Bormed healthcare portfolio for extrusion blow moulding and injection blow moulding of pharmaceutical and diagnostic containers. The grade is characterised by a nominal density of 0.960 g/cm³ measured according to ISO 1183-1 and a melt flow rate of 0.7 g/10 min at 190 °C with a 2.16 kg load according to ISO 1133-1. Representative tensile stress at yield is 26 MPa and elongation at break exceeds 350 % when tested under ISO 527-2. Flexural modulus is approximately 1,200 MPa under ISO 178. Environmental stress crack resistance exceeds 500 h in 100 % Igepal at 50 °C under ASTM D1693. The formulation contains no intentionally added phthalates, latex, or animal-derived components. Typical container sizes range from 5 mL to 500 mL for dropper bottles, ampoules, vials, and diagnostic reagent containers. Regulatory evaluation includes Ph. Eur. 3.1.3, USP <661.1>, and FDA 21 CFR 177.1520. The material is not a barrier resin; oxygen and carbon dioxide transmission are characteristic of polyolefins, and secondary barrier packaging is required for oxygen-sensitive formulations.
| Standard | Scope | Condition or limit |
|---|---|---|
| Ph. Eur. 3.1.3 | Polyolefines | Appearance of solution, acidity or alkalinity, absorbance, reducing substances |
| USP <661.1> | Plastic materials of construction | Physicochemical tests; unplasticised polyolefin requirements |
| FDA 21 CFR 177.1520 | Olefin polymers | Extractive limits per conditions of use A–H |
| EU 10/2011 | Plastic food-contact materials | Overall migration limit 10 mg/dm² |
Storage of pellets below 30 °C in sealed, damage-free packaging minimises antioxidant migration to the pellet surface. Water absorption is below 0.01 % after 24 h under ISO 62. Despite low hygroscopicity, condensation can occur when cold pellets are transferred into a cleanroom at 25 °C and relative humidity above 60 %; in that event, drying at 70 °C for 2–4 h with a desiccant drier is applied before processing. Pellets that have been stored open for more than 6 months should be rechecked for surface oxidation by carbonyl index or oxidative induction time because prolonged exposure to ozone and ultraviolet radiation in chemical storage rooms can deplete stabilisers.
Because the grade is intended for pharmaceutical containers, change-control documentation and batch certificates are normally maintained by the supplier. Downstream converters should retain lot-specific documentation linking resin batch, processing line, and finished container lot. This linkage supports extractables and leachables investigations when a deviation is observed in pH, conductivity, or ultraviolet absorbance of the packaged drug product.
On continuous extrusion blow moulding equipment, melt temperature is the primary control parameter. A 60 mm barrier screw with an L/D ratio of 24:1–30:1 and a grooved feed section is typical for commercial production of pharmaceutical bottles. Barrel set points from feed to metering are commonly 160 °C, 175 °C, 185 °C, and 190 °C; parison head zones are held at 185–195 °C, and the die temperature is controlled at 190 °C. Melt temperature should remain inside 175–195 °C. Below 175 °C, melt viscosity raises head pressure above 30 MPa on small die gaps and promotes sharkskin melt fracture; above 200 °C, residual processing stabilisers can be consumed, reducing oxidative induction time and increasing the probability of carbonyl formation.
Parison die gaps from 1.5 mm to 2.5 mm and blow air pressure between 0.6 MPa and 1.0 MPa are typical for containers of 50–500 mL. Mold temperatures of 10–18 °C provide sufficient cooling without condensation in cleanrooms operated at relative humidity above 60 %. Under these conditions, wall thickness variation of ±0.2 mm is commercially observed on 100 mL diagnostic bottles, although published data for this specific configuration is limited. Batch-to-batch melt flow variation should be monitored by in-line capillary rheometry or by duplicate ISO 1133-1 determinations because a shift of 0.05 g/10 min can alter parison sag and top-load compaction.
Gel formation is a practical failure mode on extrusion blow moulding lines when melt residence time exceeds 10 min or when hot-runner zones remain stagnant during line stoppage. Gels can be detected by film cast tests at 190 °C using a 100 μm slit die. A gel count above 5 particles/m² larger than 50 μm indicates degraded resin or contamination. Stagnant molten resin should be purged with a pharmaceutical-acceptable HDPE purging compound if shutdown exceeds 30 min.
The grade must be validated in the final container geometry because extractables are a function of processing history, surface-to-volume ratio, and sterilisation load, not only resin composition. Under Ph. Eur. 3.1.3, the polymer is evaluated for appearance of solution, acidity or alkalinity, absorbance, and reducing substances on aqueous extracts. USP <661.1> imposes physicochemical tests for plasticised and unplasticised materials; the grade is unplasticised and contains no intentionally added phthalates. FDA 21 CFR 177.1520 covers olefin polymers for food-contact use and requires the finished article to meet extractive limits under the conditions of use.
For regulated pharmaceutical packaging, terminal sterilisation by ethylene oxide or gamma irradiation up to 25 kGy is commonly applied. Gamma doses above 25 kGy can reduce elongation at break and generate peroxide species that alter the extractables profile; validation is required for each dose and geometry. Steam autoclaving above 121 °C is outside the practical operating boundary for load-bearing containers because the Vicat softening temperature of approximately 126 °C under ISO 306/A50 is close to the sterilisation temperature, and top-load collapse may occur before the cycle completes. Continuous service above 65 °C is not recommended for load-bearing containers.
Olefin polymers can sorb non-polar organic compounds from aqueous and lipid-containing formulations. For active pharmaceutical ingredients with log P above 3, sorption studies should be performed because the drug can migrate into the container wall and reduce assay potency. Conversely, leachables from the polymer can partition into lipophilic formulations more readily than into water. Extraction with 50 % ethanol or isopropanol is often used as a worst-case solvent in analytical screening; the final acceptance criteria must be derived from the dosage form and the labeled shelf life.
Injection blow moulding of HE9621-PH-1 requires a heated manifold and core-rod system maintained at 180–200 °C. Injection pressure from 40 MPa to 80 MPa and holding pressure from 20 MPa to 40 MPa are representative for multi-cavity tooling; injection speed should be set to fill the preform in 0.5–1.0 s to avoid premature gate freeze-off. Core rod temperature is controlled at 100–120 °C and blow mould temperature at 15–25 °C. Post-mould linear shrinkage of HDPE is anisotropic and typically ranges from 1.5 % to 2.0 % after 24 h under ISO 294-4. Dimensional audits should be performed no earlier than 24 h after moulding because crystallinity development continues after ejection and can shift bottleneck and thread dimensions. Hot runners and nozzles should be purged with a pharmaceutical-acceptable HDPE purging compound if shutdown exceeds 30 min to prevent gel formation from stagnant molten resin.
Environmental stress crack resistance is controlled by tie-molecule density and lamellar orientation. Under ASTM D1693 conditions, the grade sustains 500 h without failure in 100 % Igepal at 50 °C. The stress crack mechanism in blow moulded containers is not identical to compression-moulded test plaques; weld lines, pinch-off tails, and parison thinning can reduce local time-to-failure. For diagnostic reagent bottles containing 0.1–1.0 % nonionic surfactant, burst tests after chemical exposure should be run at 40 °C for 14 days and compared with unexposed controls using ISO 1167 or axial compression ISO 8113. A reduction in break strength greater than 15 % indicates stress crack activity and requires redesign of the pinch-off or material substitution. Published data for this specific configuration is limited.
Surfactant-containing liquid reagents attack polyethylene primarily by lowering the energy required for craze fibril rupture under hoop stress. The higher molecular weight fraction in HE9621-PH-1 increases the number of tie molecules bridging adjacent lamellae, which delays crack propagation. However, the effect is geometry-sensitive. In a bottle with an abrupt container-bottom radius below 3 mm, local stress concentration can negate the intrinsic ESCR advantage. Radiusing the bottom corner to at least 5 mm and controlling pinch-off flash are therefore as critical as resin selection.
Substitution of HE9621-PH-1 for an unmodified HDPE blow moulding grade requires revalidation of wall thickness distribution, seal integrity, and extractables. The higher molecular weight and controlled comonomer distribution produce higher ESCR values than many general-purpose HDPE grades, but the melt flow rate is lower, which reduces screw throughput in lightweighting programmes. Compared with LDPE, HE9621-PH-1 increases tensile modulus from approximately 200 MPa to 1,200 MPa and reduces water vapour transmission rate by roughly half to two-thirds, although the exact value depends on thickness and test method. Water vapour transmission of 0.3–0.5 g·mm/(m²·day) at 38 °C and 90 % RH under ASTM F1249 is typical for HDPE; published data for this specific configuration is limited.
Compared with random copolymer polypropylene, HE9621-PH-1 has a lower Vicat softening temperature, approximately 126 °C versus 150 °C for polypropylene, and lower oxygen-barrier performance. However, HDPE retains impact and crack resistance under sub-ambient conditions and is easier to seal by ultrasonic and heat methods. The choice between HDPE and polypropylene for regulated containers must be based on autoclave need, hot-fill need, and closure torque retention. The material is not a barrier resin; if containers require oxygen transmission below 10 cm³/(m²·day·bar) at 23 °C under ISO 15105-2, a multilayer structure with EVOH or polyamide is necessary. Regulatory equivalence cannot be assumed across suppliers; the finished drug product must be revalidated when the resin source is changed because extractables and leachables are process-dependent.