Description:
Our Medical-Grade Silicone Compression Molding O-Rings are crafted using advanced compression molding techniques, guaranteeing superior biocompatibility, flexibility, and long-lasting durability. Manufactured from FDA-compliant and ISO 13485-certified medical-grade silicone, these O-rings are engineered to withstand extreme temperatures, harsh chemicals, and rigorous sterilization processes, making them the optimal choice for medical device applications, fluid sealing, and pharmaceutical use.
At our facility, we specialize in providing tailored solutions, from custom design and prototyping to large-scale production. As a trusted OEM partner, we ensure rigorous quality control and strict adherence to international medical standards, delivering reliable and compliant products every time.
Features:
- Place of Origin:Xiamen, China
- Brand Name:OEM
- Sample:Available
- Material:Silicone or Customized
- Color:Black, Red, or As Requested
- Application:Medical Industry
- Hardness:20-90 Shore A
- Certificates:ISO, RoHS, FDA
- OEM:Available
- Lead Time:20-25 Days
Production Process:
- Material Selection & Preparation
High-purity, platinum-cured silicone (LSR/HCR) is chosen to meet USP Class VI, FDA, and ISO 10993 standards. Rigorous testing ensures biocompatibility and chemical stability.
- Tooling Design
Precision molds are created using CNC machining or 3D printing, optimized with mold flow analysis to prevent defects and ensure accuracy in dimensions and tolerances.
- Molding & Curing
– Injection/Compression Molding: Silicone is processed at controlled temperatures (120–200°C) for consistent cross-linking and uniform density.
– Post-Curing: Secondary vulcanization removes volatiles, enhancing thermal stability and mechanical properties.
- Deflashing & Surface Finishing
Automated deflashing methods and polishing achieve a smooth surface finish (Ra ≤0.8μm) for sterile applications.
- Cleaning & Sterilization
O-rings undergo ultrasonic cleaning and IPA rinsing, with optional gamma or EO sterilization to meet ISO 11137/11135 standards.
- Quality Control & Traceability
100% inspection via CMM, tensile testing, and leak detection ensures compliance with ISO 13485 and FDA 21 CFR Part 820. Full traceability and lot-controlled packaging prevent contamination.
- Certified Delivery
Vacuum-sealed packaging in a Class 8 cleanroom ensures product integrity, with certificates (RoHS, REACH, FDA) provided for regulatory compliance.
Why Partner with Us?
- Proven Industry Expertise
With over 20 years of experience in silicone manufacturing, we specialize in producing precision-engineered silicone products that meet the highest standards of quality and performance, tailored to your exact needs.
- Tailored Solutions
Offering comprehensive OEM services, we provide full customization options for logos, designs, and technical specifications, ensuring that every product aligns perfectly with your brand’s requirements.
- Dedicated Customer Support
Our knowledgeable team provides personalized, end-to-end support, guiding you from the initial design phase to final delivery, ensuring a seamless and efficient experience throughout.
- Commitment to Quality
We adhere to stringent quality control processes, ensuring that every product meets or exceeds industry standards. Our unwavering focus on reliability, consistency, and excellence has built our strong reputation in the industry.
Factory Show:
Our advanced manufacturing facility is equipped with cutting-edge technologies, including CNC machining, Mirror EDM, EDM, and Slow-Speed Wire Cutting (WC), ensuring exceptional precision in mold production. We operate a high-capacity fleet of 15 rubber compression molding machines and 2 LSR injection molding machines, optimizing both throughput and operational efficiency.
To maintain superior quality standards, we utilize state-of-the-art inspection tools such as 3D projectors, sealing testers, durometers, and elasticity measurement devices, all meticulously managed by our expert quality control team. Our processes are fully compliant with ISO 9001 and IATF 16949 certifications, guaranteeing consistent and reliable results.
Additionally, we incorporate advanced automated systems, including AutoDryers, high-speed doming machines, and die-cutting equipment, to enhance production efficiency and accuracy. To ensure the highest levels of cleanliness and precision, we also operate a Class 8 cleanroom for sterile production environments. This commitment to leveraging cutting-edge technology guarantees the consistent delivery of high-performance products.
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