Customized Medical Grade Silicone O Rings for Medical Industry Suppliers

Overview:

Our medical-grade silicone O-rings are manufactured using high-precision liquid silicone rubber (LSR) injection molding and compression molding processes, ensuring exceptional biocompatibility, flexibility, and durability. Made from FDA-compliant, ISO 13485-certified medical-grade silicone, these O-rings offer excellent resistance to temperature extremes, chemicals, and sterilization processes, making them ideal for medical devices, fluid sealing, and pharmaceutical applications.At our facility, we provide custom design, prototyping, and full-scale production with one-stop OEM solutions, ensuring strict quality control and compliance with global medical standards.

Basic Information:

Benefits of Our O-rings:

1. Superior Material Integrity
2. Precision-Driven Tooling & Molding
3. Enhanced Durability via Post-Vulcanization
4. Sterile-Ready Finishing & Traceability

Manufacturing Process:

1. Material Selection & Preparation

High-purity platinum-cured silicone (LSR/HCR) is selected to comply with USP Class VI, FDA, and ISO 10993 standards. Raw materials undergo rigorous purity testing to ensure biocompatibility and chemical stability.

2. Custom Tooling Design

Precision molds are CNC-machined or 3D-printed based on client specifications (ID/OD, cross-section, tolerance). Mold flow analysis optimizes geometry to prevent defects like flash or air traps.

3. Formation Process

– Injection/Compression Molding: LSR/HCR is injected or compressed under controlled temperature (120–200°C) and pressure, achieving consistent cross-linking for uniform density.

– Post-Curing: Secondary vulcanization removes residual volatiles, enhancing thermal stability and mechanical properties.

4. Deflashing & Surface Finishing

Automated trimming (cryogenic, robotic) removes excess material. Surfaces are polished or coated to meet Ra ≤0.8μm smoothness for sterile applications.

5. Cleaning & Sterilization

O-rings undergo ultrasonic cleaning and IPA rinsing. Optional gamma/EO sterilization ensures compliance with ISO 11137/11135 for critical medical devices.

6. Quality Assurance & Traceability

100% inspected via CMM, tensile testers, and leak detectors. Full documentation (DHR, COC, material traceability) aligns with ISO 13485 and FDA 21 CFR Part 820. Lot-controlled packaging prevents contamination.

7. Certified Delivery

Components are vacuum-sealed in cleanroom conditions (Class 8/100k) and shipped with compliance certificates (RoHS, REACH, FDA).

Factory Show:

Our state-of-the-art manufacturing facility is equipped with advanced technologies such as CNC machining, Mirror EDM, EDM, and Slow-Speed Wire Cutting (WC), ensuring exceptional precision in mold production. With a well-established fleet of 15 rubber compression molding machines and 2 LSR injection molding machines, we optimize both production capacity and operational efficiency.

To uphold the highest quality standards, we employ advanced testing equipment including 3D projectors, sealing testers, durometers, and elasticity measurement instruments, all rigorously managed by our dedicated quality control team. Our processes are fully compliant with ISO 9001 and IATF 16949 certifications, ensuring consistent product reliability and performance.

Additionally, we integrate sophisticated automated systems such as AutoDryers, high-speed doming machines, and die-cutting equipment to streamline production, enhance precision, and increase throughput. This commitment to leveraging advanced technology enables us to deliver products of superior quality, functionality, and performance.