| Quantity: | |
|---|---|
YIXUN mold
8480419090
Mold Base: 304 Stainless Steel – Corrosion-resistant, easy to sterilize, and compatible with medical cleanroom environments; supports 800,000+ injection cycles.
Cavity & Core: ASSAB S136 ESR Steel – Vacuum heat-treated to HRC 52-54, offering exceptional wear resistance against TPE/LDPE flow and preventing micro-deformations; polished to Ra 0.01μm for smooth stopper surfaces (avoids drug residue adhesion).
Dual-Material Compatibility: Molded with dedicated TPE and LDPE injection ports, plus temperature-controlled flow channels—ensures strong bonding between the two materials (no delamination) and uniform material distribution.
Anti-Stick Coatings: PTFE-coated cavity surfaces – Prevents TPE from adhering to the mold during ejection, reducing defects and ensuring clean, burr-free stoppers.
| Cavity Count | Daily Output (8-Hour Shift) | Applicable Stopper Size | Key Advantage |
| 16-Cavity | 12,000-15,000 stoppers | 8mm-15mm (vial stoppers) | Balances efficiency and precision; ideal for medium-volume production. |
| 32-Cavity | 25,000-30,000 stoppers | 5mm-12mm (syringe stoppers) | High-volume output; reduces unit cost for mass-market medical products. |
| 64-Cavity | 50,000-60,000 stoppers | 3mm-8mm (micro-vial stoppers) | Ultra-high efficiency for small-size stoppers (e.g., laboratory reagents). |
Sealing Precision: Molded TPE sealing lips with tolerance ±0.02mm – Ensures airtight, leak-proof fit with vial/syringe necks (tested to 0.5MPa air pressure with no leakage).
Sterility Compatibility: Smooth, crevice-free cavity design – Eliminates dead corners where bacteria could accumulate; compatible with ETO (ethylene oxide) and gamma sterilization.
Dual-Material Bonding: Optimized gate positions and temperature control (TPE: 180-200℃; LDPE: 190-210℃) – Ensures permanent adhesion between TPE and LDPE, preventing material separation during use.
Ejection System: Soft-eject pins with rounded tips – Avoids damage to the delicate TPE sealing layer and ensures consistent stopper geometry.
Certifications: Complies with ISO 13485 (medical device manufacturing), ISO 10993 (biocompatibility), and USP Class VI (plastic materials for medical use).
Material Traceability: Full documentation for mold steel, coatings, and auxiliary components – Meets pharmaceutical regulatory requirements (e.g., FDA 21 CFR Part 820, EU MDR).
Rigorous Testing:
72-hour continuous cycle testing with TPE+LDPE materials to verify stability.
100% dimensional inspection via CMM (focus on sealing lip thickness, outer diameter, and TPE-LDPE bonding area).
Biocompatibility testing (cytotoxicity, sensitization) for molded stoppers (test reports provided upon request).
| Parameter | Details |
| Mold Size | 500×400×300mm (16-cavity) ~ 700×550×400mm (64-cavity) |
| Applicable Injection Machine | Dual-material machines (100-200 tons; with separate TPE/LDPE hoppers) |
| Cycle Time | 25-35 seconds (varies by cavity count: 25s for 16-cavity; 35s for 64-cavity) |
| Service Life | ≥800,000 injection cycles |
| Dimensional Accuracy | ±0.03mm (critical features: sealing lip, outer diameter) |
| Stopper Compatibility | Vials (5mL-100mL), syringes (1mL-50mL), ampoules (1mL-20mL) |
| Surface Finish | Mirror polish (Ra 0.01μm) for cavity/core; matte finish for mold base |
Tailored Stopper Designs: Accept 2D/3D drawings for custom stopper shapes (e.g., convex, concave, with pull tabs), TPE/LDPE thickness ratios, and logo embossing (for brand identification).
Cavity Optimization: Adjust cavity count and layout based on production volume (from 8-cavity small-batch to 64-cavity mass production).
Material Adaptation: Modify mold for alternative medical-grade materials (e.g., TPE+PP, TPE+PE) with upgraded temperature control systems.
After-Sales Service: 24-month warranty (covers material defects and manufacturing issues); free mold maintenance training and 24/7 technical support (including on-site debugging for cleanroom facilities).
Lead Time: 35-45 days (standard 16/32-cavity mold); 50-60 days (custom 64-cavity or special-shaped stopper molds).
MOQ: 1 set (bulk discounts for 2+ sets; free sample stoppers for qualification testing).
Packaging & Delivery: Cleanroom-compatible packaging (anti-static, sterile bags) + heavy-duty wooden crate; FOB Shanghai/Ningbo or door-to-door delivery (with customs clearance support for medical equipment).
Dual-Material Expertise: Ensures strong TPE-LDPE bonding and consistent stopper performance for medical sealing.
Medical Compliance: Meets global pharmaceutical standards, eliminating regulatory risks for end-users.
Scalable Production: Multi-cavity options adapt to small-batch R&D or large-volume commercial production.
Sterility Assurance: Smooth, crevice-free design and sterilization compatibility ensure safe use with drugs and biologics.
Mold Base: 304 Stainless Steel – Corrosion-resistant, easy to sterilize, and compatible with medical cleanroom environments; supports 800,000+ injection cycles.
Cavity & Core: ASSAB S136 ESR Steel – Vacuum heat-treated to HRC 52-54, offering exceptional wear resistance against TPE/LDPE flow and preventing micro-deformations; polished to Ra 0.01μm for smooth stopper surfaces (avoids drug residue adhesion).
Dual-Material Compatibility: Molded with dedicated TPE and LDPE injection ports, plus temperature-controlled flow channels—ensures strong bonding between the two materials (no delamination) and uniform material distribution.
Anti-Stick Coatings: PTFE-coated cavity surfaces – Prevents TPE from adhering to the mold during ejection, reducing defects and ensuring clean, burr-free stoppers.
| Cavity Count | Daily Output (8-Hour Shift) | Applicable Stopper Size | Key Advantage |
| 16-Cavity | 12,000-15,000 stoppers | 8mm-15mm (vial stoppers) | Balances efficiency and precision; ideal for medium-volume production. |
| 32-Cavity | 25,000-30,000 stoppers | 5mm-12mm (syringe stoppers) | High-volume output; reduces unit cost for mass-market medical products. |
| 64-Cavity | 50,000-60,000 stoppers | 3mm-8mm (micro-vial stoppers) | Ultra-high efficiency for small-size stoppers (e.g., laboratory reagents). |
Sealing Precision: Molded TPE sealing lips with tolerance ±0.02mm – Ensures airtight, leak-proof fit with vial/syringe necks (tested to 0.5MPa air pressure with no leakage).
Sterility Compatibility: Smooth, crevice-free cavity design – Eliminates dead corners where bacteria could accumulate; compatible with ETO (ethylene oxide) and gamma sterilization.
Dual-Material Bonding: Optimized gate positions and temperature control (TPE: 180-200℃; LDPE: 190-210℃) – Ensures permanent adhesion between TPE and LDPE, preventing material separation during use.
Ejection System: Soft-eject pins with rounded tips – Avoids damage to the delicate TPE sealing layer and ensures consistent stopper geometry.
Certifications: Complies with ISO 13485 (medical device manufacturing), ISO 10993 (biocompatibility), and USP Class VI (plastic materials for medical use).
Material Traceability: Full documentation for mold steel, coatings, and auxiliary components – Meets pharmaceutical regulatory requirements (e.g., FDA 21 CFR Part 820, EU MDR).
Rigorous Testing:
72-hour continuous cycle testing with TPE+LDPE materials to verify stability.
100% dimensional inspection via CMM (focus on sealing lip thickness, outer diameter, and TPE-LDPE bonding area).
Biocompatibility testing (cytotoxicity, sensitization) for molded stoppers (test reports provided upon request).
| Parameter | Details |
| Mold Size | 500×400×300mm (16-cavity) ~ 700×550×400mm (64-cavity) |
| Applicable Injection Machine | Dual-material machines (100-200 tons; with separate TPE/LDPE hoppers) |
| Cycle Time | 25-35 seconds (varies by cavity count: 25s for 16-cavity; 35s for 64-cavity) |
| Service Life | ≥800,000 injection cycles |
| Dimensional Accuracy | ±0.03mm (critical features: sealing lip, outer diameter) |
| Stopper Compatibility | Vials (5mL-100mL), syringes (1mL-50mL), ampoules (1mL-20mL) |
| Surface Finish | Mirror polish (Ra 0.01μm) for cavity/core; matte finish for mold base |
Tailored Stopper Designs: Accept 2D/3D drawings for custom stopper shapes (e.g., convex, concave, with pull tabs), TPE/LDPE thickness ratios, and logo embossing (for brand identification).
Cavity Optimization: Adjust cavity count and layout based on production volume (from 8-cavity small-batch to 64-cavity mass production).
Material Adaptation: Modify mold for alternative medical-grade materials (e.g., TPE+PP, TPE+PE) with upgraded temperature control systems.
After-Sales Service: 24-month warranty (covers material defects and manufacturing issues); free mold maintenance training and 24/7 technical support (including on-site debugging for cleanroom facilities).
Lead Time: 35-45 days (standard 16/32-cavity mold); 50-60 days (custom 64-cavity or special-shaped stopper molds).
MOQ: 1 set (bulk discounts for 2+ sets; free sample stoppers for qualification testing).
Packaging & Delivery: Cleanroom-compatible packaging (anti-static, sterile bags) + heavy-duty wooden crate; FOB Shanghai/Ningbo or door-to-door delivery (with customs clearance support for medical equipment).
Dual-Material Expertise: Ensures strong TPE-LDPE bonding and consistent stopper performance for medical sealing.
Medical Compliance: Meets global pharmaceutical standards, eliminating regulatory risks for end-users.
Scalable Production: Multi-cavity options adapt to small-batch R&D or large-volume commercial production.
Sterility Assurance: Smooth, crevice-free design and sterilization compatibility ensure safe use with drugs and biologics.
