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ISO13485 Injection Plastic Mold Maker Plastic Caps Over Mold TPU 1+1Cavity P20 Material

As a specialized manufacturer of medical plastic components, we present high-performance injection-molded plastic caps engineered to seal test tubes, reagent bottles, sampling tubes, and other medical containers. Designed with precision (injection molding) technology, our caps prioritize leak-proof protection, sterile integrity, and compatibility with medical-grade containers—critical for preserving sample purity, preventing cross-contamination, and ensuring compliance with global healthcare standards. Ideal for clinical diagnostics, laboratory research, pharmaceutical packaging, and point-of-care testing (POCT), our plastic caps deliver reliable sealing performance for sensitive medical applications.
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  • YIXUN mold

  • 8480419090

Medical-Grade Injection-Molded Plastic Caps: Secure Sealing Solutions for Healthcare Containers

Introduction

As a specialized manufacturer of medical plastic components, we present high-performance injection-molded plastic caps engineered to seal test tubes, reagent bottles, sampling tubes, and other medical containers. Designed with precision (injection molding) technology, our caps prioritize leak-proof protection, sterile integrity, and compatibility with medical-grade containers—critical for preserving sample purity, preventing cross-contamination, and ensuring compliance with global healthcare standards. Ideal for clinical diagnostics, laboratory research, pharmaceutical packaging, and point-of-care testing (POCT), our plastic caps deliver reliable sealing performance for sensitive medical applications.

Core Product Advantages

1. Precision Injection-Molded Quality

✅ Dimensional Consistency: Molded with CNC-machined cavities (tolerance ±0.01mm) to ensure perfect fit with medical containers (test tubes, vials, bottles) of standard or custom sizes.
✅ Uniform Wall Thickness: Optimized 0.6-1.0mm thickness via advanced injection molding parameters, balancing durability and easy handling.
✅ Flash-Free Design: Smooth, burr-free surfaces (Ra ≤0.03μm) to avoid damaging container rims or contaminating samples.
✅ Batch Consistency: Automated injection molding lines guarantee consistent quality across high-volume production (1M+ units/month), ideal for OEM/ODM partnerships.

2. Medical-Grade Materials & Safety

✅ Premium Biocompatible Plastics:
  • PP (Polypropylene): FDA 21CFR §177.1520 compliant, chemical-resistant (alcohols, disinfectants), heat-resistant (121℃ autoclaving), and non-toxic (ISO 10993 certified).

  • PE (Polyethylene): Flexible, impact-resistant, and suitable for low-temperature storage (-20℃ to 80℃).

  • PET (Polyethylene Terephthalate): High rigidity, transparency, and barrier properties for sensitive reagents.

    ✅ Sterile Assurance: Gamma-irradiated (ISO 11137) or ethylene oxide (EO) sterilized, achieving Sterility Assurance Level (SAL) ≥10⁻⁶. Sterile packaging (individual peelable packs or bulk sterile bags) prevents post-production contamination.

    ✅ Leach-Resistant: No heavy metals, phthalates, or harmful additives, ensuring sample/reagent integrity for diagnostic accuracy.

3. Superior Sealing Performance

✅ Leak-Proof Design:
  • Threaded Caps: Precision-molded threads for tight engagement, preventing liquid/gas leakage even during centrifugation (up to 15,000rpm) or transportation.

  • Snap-On Caps: Secure snap-fit mechanism with ribbed inner lining, ensuring instant sealing for disposable containers (e.g., sampling tubes).

  • Gasket-Equipped Options: Compatible with rubber/silicone gaskets (FDA-approved) for enhanced sealing, ideal for volatile reagents or long-term storage.

    ✅ Contamination Protection: Seals effectively against dust, moisture, and microbial ingress, extending sample/reagent shelf life.

4. Versatile Product Range

Cap Type Compatibility Material Key Features Applications
Threaded Plastic Cap Test tubes, reagent bottles, vials PP/PE/PET Precision threads, optional gasket, color-coded Clinical sample storage, pharmaceutical packaging
Snap-On Cap Disposable sampling tubes, centrifuge tubes PP/PE Easy snap-fit, leak-proof, sterile Rapid diagnostic kits, point-of-care testing
Press-Fit Cap Small vials, microcentrifuge tubes PE Low-profile design, secure fit Molecular biology research, reagent packaging
Tamper-Evident Cap Pharmaceutical bottles, diagnostic reagent containers PP/PET Tamper-proof ring, clear indication of opening Prescription drugs, high-value reagents
Color-Coded Cap Multi-sample containers, test tubes PP/PE Color-coded (red/blue/green/yellow) for sample identification Hematology, clinical chemistry testing

Compliance & Quality Control

  • Global Certifications: ISO 13485 (Medical Device QMS), FDA 21CFR §177, CE Marking (MDR 2017/745), USP Class VI, ISO 10993 (Biocompatibility: Cytotoxicity, Sensitization).

  • Rigorous QC Process:

    • Incoming Inspection: Material certification (MTR) and biocompatibility report verification.

    • In-Process Monitoring: Real-time tracking of injection pressure, temperature, and thread precision.

    • Final Testing: Leakage testing (under 0.5MPa pressure), dimensional inspection (CMM), and sterility sampling.

  • Full Traceability: Batch numbering system covering raw materials, production parameters, and sterilization details for regulatory compliance.

Applications

✅ Clinical Diagnostics: Sealing blood/urine/saliva samples in test tubes, preventing contamination during transport and testing.
✅ Pharmaceutical Packaging: Securing liquid/gel reagents, drugs, and medical devices (e.g., insulin vials, vaccine bottles).
✅ Laboratory Research: Sealing centrifuge tubes, microvials, and culture media containers for cell biology, molecular research, and forensic analysis.
✅ Point-of-Care Testing (POCT): Snap-on caps for disposable sampling tubes in rapid diagnostic kits (e.g., COVID-19, glucose testing).
✅ Veterinary Medicine: Sealing animal sample containers for livestock/pet healthcare and research.

Customization Services

We offer flexible customization to meet your specific requirements:
  • Size & Fit: Custom thread designs (e.g., 13mm, 16mm, 20mm) or snap-fit dimensions to match your containers (test tubes, bottles, vials).

  • Material & Color: Choose PP/PE/PET or custom-engineered plastics; color-coding (Pantone-matched) for sample/reagent identification.

  • Design Modifications: Add gaskets, tamper-evident rings, embossed logos, or barcode printing.

  • Packaging Solutions: Individual sterile packs, bulk sterile bags, or custom packaging with your brand logo.

  • Rapid Prototyping: 3-5 day turnaround for injection-molded prototypes to validate fit and functionality.

Why Choose Our Injection-Molded Plastic Caps?

Medical-Grade Expertise: Focus on healthcare applications with 10+ years of experience in medical plastic injection molding.
Secure Sealing: Proven leak-proof performance for sensitive samples and reagents.
Global Compliance: Full certification package for easy market access (US, EU, Asia).
Scalability: High-volume production capacity with competitive pricing for distributors and OEM/ODM partners.
Customer-Centric Support: Dedicated engineering team to assist with design optimization and technical troubleshooting.

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