| Quantity: | |
|---|---|
YIXUN mold
8480419090
This precision injection mold is engineered specifically for the high-volume production of disposable medical syringes and related medical consumables. Manufactured under ISO13485 quality management systems and cleanroom conditions, this mold meets the stringent requirements of the medical device industry for precision, cleanliness, and regulatory compliance.
Designed for medical-grade materials including polypropylene (PP) and polyethylene (PE), the mold produces syringe components—barrels, plungers, and plunger rods—that comply with international medical standards. Every aspect of the mold's design, material selection, and manufacturing process prioritizes patient safety, product consistency, and production efficiency.
| Specification | Detail |
|---|---|
| Product Type | Disposable Syringe Injection Mold (Barrel / Plunger / Plunger Rod) |
| Quality Management | ISO13485:2016 |
| Manufacturing Environment | Class 100,000 / Class 8 Cleanroom (ISO 14644) |
| Material Compatibility | Medical-Grade Polypropylene (PP), Polyethylene (PE) |
| Mold Steel | S136 / 2316 / 420ESR (Stainless, Corrosion-Resistant) |
| Surface Finish | SPI A2 / A3 (Mirror / High-Gloss) or specific medical surface requirements |
| Cavity Configuration | Multi-cavity (16 / 32 / 48 / 64 cavities, customizable) |
| Runner System | Hot Runner (Valve Gate) / Cold Runner (customizable) |
| Mold Life | 1,000,000+ shots |
| Standard Compliance | FDA 21 CFR, USP Class VI, ISO 10993 (as applicable) |
| Lead Time | 45-60 days |
This mold is manufactured under a fully certified ISO13485:2016 quality management system, specifically designed for the medical device industry. Key elements include:
| ISO13485 Requirement | Implementation |
|---|---|
| Design Controls | Comprehensive design history file (DHF) with risk management per ISO14971 |
| Traceability | Full material traceability from raw steel to finished mold, with batch records |
| Change Control | Rigorous documentation and approval process for any design modifications |
| Validation | IQ / OQ / PQ protocols for process validation |
| Supplier Control | Approved supplier list with regular audits |
The mold is produced and maintained in a controlled cleanroom environment to prevent contamination that could compromise medical device safety.
| Parameter | Specification |
|---|---|
| Cleanroom Classification | Class 100,000 (ISO 8) or better |
| Air Quality | HEPA-filtered with positive pressure |
| Temperature Control | 20 ± 2°C |
| Humidity Control | 50 ± 10% RH |
| Personnel Protocol | Gowning procedures, restricted access, regular monitoring |
Benefits:
Prevents particulate contamination that could affect syringe function
Eliminates microbial contamination risks
Ensures mold surfaces remain pristine before shipment
Provides documented evidence of cleanliness for regulatory submissions
Syringe molding presents unique challenges requiring specialized design solutions:
Barrel Mold:
Requires precise dimensional accuracy for plunger seal fit (typically ±0.01mm on critical diameters)
Mating surfaces must achieve smooth, leak-free sealing
Needle hub interface (Luer taper) demands exact geometry for connector compatibility
Volume markings must be clear, permanent, and accurately positioned
Transparency requirements demand mirror-polished cavities (SPI A2/A3)
Plunger & Rod Mold:
Rubber seal/plunger tip requires controlled compression
Rod must be rigid with precise length tolerance
Sliding surfaces require surface finish optimization
Medical molds operate in potentially corrosive environments and require extended mold life.
| Steel Grade | Properties | Application |
|---|---|---|
| S136 (STAVAX) | Premium stainless, corrosion-resistant, excellent polishability, high toughness | High-volume, critical cosmetic surfaces, mirror finishes |
| 2316 (DIN) | Stainless, good corrosion resistance, suitable for medical and food contact | General medical applications |
| 420ESR | Martensitic stainless, high hardness, good wear resistance | High-wear areas, guide pins, ejector components |
All steel grades are selected based on:
Corrosion resistance against molding materials and cleaning agents
High polishability for transparent components
Thermal conductivity for efficient cooling
Wear resistance for extended mold life
Maximizes production efficiency while maintaining consistent part quality across all cavities.
| Cavity Count | Typical Application | Output per Cycle |
|---|---|---|
| 16 Cavities | Small-scale / validation runs | Balanced production |
| 32 Cavities | Mid-volume production | 3-5 second cycle time |
| 48 Cavities | High-volume production | High efficiency |
| 64+ Cavities | Mass production | Maximum output |
Quality Assurance Across Cavities:
Balanced runner system ensures consistent fill across all cavities
Individual cavity pressure monitoring (optional)
Cavity numbering for traceability
Hot runner with individual temperature control per nozzle
| Finish | Grade | Application |
|---|---|---|
| SPI A2 | Mirror finish (6000 grit) | Syringe barrels requiring high clarity and transparency |
| SPI A3 | High-gloss (1200 grit) | Plunger rods and general medical components |
| Specific Medical | Custom texture for seal surfaces | Plunger sealing surfaces requiring controlled roughness |
This mold is optimized for processing medical-grade polypropylene and polyethylene.
| Material Property | PP (Barrel / Rod) | PE (Plunger / Seal) |
|---|---|---|
| Melt Temperature | 220 - 260°C | 190 - 230°C |
| Mold Temperature | 20 - 50°C | 20 - 50°C |
| Shrinkage | 1.5 - 2.5% | 1.5 - 3.0% |
| Transparency | High clarity (barrel) | Translucent (seal) |
Material Benefits:
USP Class VI certified for biocompatibility
Suitable for ethylene oxide (EtO), gamma, and steam sterilization
Excellent chemical resistance (drugs, solvents)
Low extractables and leachables
Proven track record in medical device applications
Cleanroom Assembled: No contamination introduced during mold assembly
Corrosion-Resistant Steel: Prevents rust that could contaminate medical parts
Smooth Surfaces: Easy cleaning and sterilization of the mold itself
Sealed Cooling Circuits: No risk of coolant leakage into production area
1 Million+ Shot Life: Minimizes production interruptions
Hardened Components: Guide pins, bushings, ejector pins for extended wear resistance
Precision Cooling: Balanced cooling channels for consistent cycle times and part dimensions
Easy Maintenance: Designed for quick component replacement to minimize downtime
Design History File (DHF): Complete design and development documentation
Device Master Record (DMR): All specifications, procedures, and drawings
Inspection Reports: Dimensional and material certifications
Validation Protocols: IQ, OQ, PQ documentation
Risk Management File: Per ISO14971
| Application | Description |
|---|---|
| Hypodermic Syringes | Standard disposable syringes for drug delivery |
| Insulin Syringes | Low-volume, high-accuracy syringes |
| Pre-Filled Syringes | Ready-to-use drug delivery systems |
| Tuberculin Syringes | Small-volume medical syringes |
| Veterinary Syringes | Animal health applications |
| Irrigation Syringes | Wound cleaning and surgical irrigation |
| Step | Process | Detail |
|---|---|---|
| 1 | Design & DFM | 3D modeling, mold flow analysis, DFM report, design review with customer |
| 2 | Steel Procurement | Certified medical-grade steel with material certification |
| 3 | Precision Machining | 5-axis CNC, EDM, wire EDM, high-speed machining |
| 4 | Heat Treatment | Hardening, tempering, annealing (as required) |
| 5 | Surface Finishing | Mirror polishing to SPI A2/A3, specific surface treatments |
| 6 | Cleanroom Assembly | Assembly under controlled cleanroom conditions |
| 7 | Mold Trials | Validation samples under process conditions |
| 8 | Quality Inspection | Full dimensional inspection with CMM, surface roughness testing |
| 9 | Documentation | Complete documentation package per ISO13485 requirements |
| Inspection Type | Method | Standard |
|---|---|---|
| Dimensional Accuracy | CMM, Optical Measurement | ±0.01mm tolerance |
| Surface Finish | Profilometer | SPI standards verification |
| Hardness Testing | Rockwell | Per material specification |
| Material Certification | Mill test certificates | Full traceability |
| Cleanliness Testing | Particle count | ISO14644 standard |
| Mold Trial Validation | First article inspection | Customer approved |
| Item | Detail |
|---|---|
| Protection | Anti-rust treatment, vacuum-sealed plastic wrapping, desiccant |
| Packaging | Wooden crate with shock absorption |
| Documentation | Inside packaging: packing list, inspection reports, maintenance manual |
| Port | Ningbo / Shanghai |
| Lead Time | 45-60 days standard (customizable) |
| Service | Detail |
|---|---|
| DFM Consultation | Design for manufacturability and process optimization |
| Mold Flow Analysis | Simulation of filling, cooling, and warpage |
| Process Validation Support | Assistance with IQ / OQ / PQ protocols |
| Trial Support | On-site or remote support during mold trials |
| Training | Operation and maintenance training for your team |
| Maintenance Support | Spare parts, repair service, maintenance guidance |
| Documentation | Complete regulatory documentation package |
ISO13485:2016 – Medical Devices Quality Management
ISO9001:2015 – Quality Management
ISO14971 – Medical Devices Risk Management (as applicable)
Cleanroom Certification – ISO14644 Class 8
Contact our medical mold engineering team for a confidential consultation on your syringe molding requirements. We provide complete documentation packages to support your regulatory submissions and validation processes.
