PP-ExxonMobil PP1013
PP-ExxonMobil PP1013 (specifically the PP1013H1 grade) is an ultra-pure homopolymer polypropylene engineered by ExxonMobil, boasting FDA DMF filing, European Pharmacopoeia compliance, and USP Class VI biocompatibility[1][2]. Featuring a melt flow rate of 7.5 g/10 min, it is exceptionally suited for high-clarity syringes, inhalers, and autoclavable labware[2][3]. At Jucheng Precision, an ISO 13485 certified contract manufacturer, we inject this medical-grade homopolymer inside certified Class 7 and Class 8 cleanrooms to prevent particulate contamination. Operating 35+ advanced molding presses, our engineers employ extended packing cycles to eliminate shrinkage voids, utilizing rust-free mirror-polished S136 stainless tool steel to ensure zero-defect parts verified by Zeiss CMM inspection.
ExxonMobil PP1013H1 Medical & Regulatory Compliance Profile
ExxonMobil™ PP1013H1 is a highly specialized homopolymer resin certified for demanding medical and pharmaceutical fluid-contact applications:
| Regulatory Standard | Certification Reference | Implication for MedTech Assemblies |
|---|---|---|
| Tương thích sinh học | USP Class VI / ISO 10993-5, 10, 11 | Guarantees zero systemic toxicity, zero skin sensitization, and zero in-vitro cytotoxicity during active fluid delivery. |
| Hồ sơ chính dược phẩm | US FDA DMF 15657 | Enables simplified drug master filing and regulatory pathway clearance for medical packaging and pre-filled syringe barrels. |
| Monograph Compliance | EP Monograph 3.1.3, 3.1.6, 3.2.2 | Complies with European Pharmacopoeia standards for plastic materials used for blood containers, tubing, and pharmaceutical closures. |
Sterilization Adaptability for ExxonMobil PP1013
Medical devices must withstand intensive sterilization cycles. This grade is optimized to maintain physical integrity across all major sterilization methods:
| Sterilization Methodology | Material Tolerance & Structural Integrity |
|---|---|
| Autoclave & Steam Sterilization | Excellent. Withstands standard pressurized steam cycles up to 121°C–134°C without mechanical warping or surface degradation. |
| Ethylene Oxide (EtO) Gas | Excellent. Highly compatible with EtO chamber sterilization, exhibiting zero gas absorption or yellowing defects. |
| Gamma Radiation | Moderate. Suitable for low-dose gamma cycles. For intensive radiation steps, post-molding yellowing is minimized via optimized cooling times. |
Scientific Molding Guide for PP-ExxonMobil PP1013
Molding medical-grade homopolymer PP requires a high level of process control to eliminate microscopic splay, particulates, and shrinkage voids:
- Cleanroom particulate control: To comply with ISO 13485 regulations, Jucheng molds this medical resin strictly inside certified ISO Class 7 and Class 8 cleanrooms. Raw materials are moved through positive-pressure enclosed pneumatic conveying systems.
- Sink-Mark and Void Mitigation: Due to PP1013’s semi-crystalline homopolymer structure, parts are prone to volumetric shrinkage voids. We mitigate this by utilizing lower injection speeds combined with extended packing pressure profiles and generous gate sizing (50% to 70% of part wall thickness).
- Gate Cosmetic and Part Integrity: For syringe plungers and inhaler bodies, gate vestige must be kept minimal. We design premium hot-runner systems or highly detailed sub-gates machined on our 5-axis CNCs to secure clean part separation.
- Mold Rust & Contamination Protection: To avoid micro-contamination, we use premium S136 stainless steel hardened to 50 HRC for our molds. This prevents any oxidation from mold sweat or condensation during long runs.
Key Application Fields for PP-ExxonMobil PP1013
- Diagnostics & Labware: Highly transparent test tubes, specimen vials, pipette tips, petri dishes, and PCR multi-well plates.
- Drug Delivery Components: Disposable syringe barrels, pre-filled syringes, inhaler bodies, insulin pen casings, and liquid medicine dispensers.
- Medical Packaging & Closures: Child-resistant pharmaceutical caps, dropper caps, sterile vial closures, and pharmaceutical blister containers.
Properties
| Mật độ | 0.900 g/cm³ |
| Melt Mass-Flow Rate (MFR) (230°C/2.16kg) | 7.5 g/10 min |
| Độ bền kéo tại điểm chảy dẻo | 33.5 MPa |
| Tensile Elongation at Yield | 8.0 % |
| Mô đun kéo | 1,500 MPa |
| Mô đun uốn | 1,480 MPa |
| Izod Impact Strength (Notched, 23°C) | 3.1 kJ/m² |
| Shore D Hardness | 65 - |
| Nhiệt độ nóng chảy | 160 °C |
| Nhiệt độ hóa mềm Vicat | 154 °C |
| Heat Deflection Temperature (HDT @ 0.45 MPa) | 86.3 °C |
| Độ co rút khuôn tuyến tính | 1.2 - 1.8 % |
| Kích thước chi tiết tối đa (Giới hạn phòng sạch) | 600 x 400 mm |
| Minimum Part Size (Microfluidic limit) | 1 x 1 mm |