Product Description:
Engineered for critical medical applications, our LSR injection molded medical-grade silicone umbrella valves ensure fail-safe, unidirectional flow control. Precision crafted from biocompatible, platinum-cure silicone, they offer consistent cracking pressure, autoclave resilience, and reliable sealing for diagnostic and therapeutic devices.
Basic Information:
| Attribute | Specification |
|---|---|
| Place of Origin | Xiamen, China |
| Shape | Umbrella/Diaphragm, Custom Designs |
| Brand Name | OEM |
| Minimum Order Quantity (MOQ) | Project-based, low volume available |
| Material | USP Class VI, Platinum-Cure LSR |
| Logo | Laser Etching (Biocompatible) |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, USP Class VI, RoHS, REACH |
| Packaging | Cleanroom, Sterile/Nested Trays |
| OEM Services | Full Service from Design to Validation |
| Primary Use | Medical & Diagnostic Fluid Management |
| Sample Lead Time | 10-14 business days |
| Sample Availability | With NDA & Design Specifications |
| Production Lead Time | 30-50 business days (Includes validation) |
Quality Assurance:
Our quality assurance for medical-grade LSR umbrella valves is an integral part of our ISO 13485 certified quality management system. It begins with rigorous supplier qualification and raw material certification (USP Class VI, FDA). The automated LSR injection molding process is conducted in a controlled environment with validated process parameters to ensure flawless, flash-free parts with perfect sealing lips. Every valve undergoes 100% functional testing on automated pressure decay testers to verify precise cracking pressure and zero backflow leakage. Dimensional integrity is confirmed using vision measurement systems. Additionally, we perform batch-specific biocompatibility testing (as required), cleanroom particle counting, and full Device History Record (DHR) traceability to guarantee patient safety and regulatory compliance.
Why Choose Us?
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Dedicated Expertise in Medical-Grade LSR Molding: We specialize in high-precision LSR manufacturing for Class I and II medical devices, with deep knowledge of material science, fluid dynamics, and stringent regulatory pathways.
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Collaborative Design for Clinical Performance: We partner with your engineering team to optimize valve design—including lip geometry, hinge thickness, and durometer—for specific fluid properties, pressure thresholds, and sterilization methods (autoclave, ETO, gamma).
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Regulatory-Compliant, Documented Manufacturing: Our ISO 13485 certified facility provides complete quality documentation, process validation (IQ/OQ/PQ), and lot traceability to support your regulatory submissions and audits seamlessly.
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Comprehensive Functional & Biocompatibility Validation: Our testing extends beyond QC to include full validation suites: cycle fatigue life testing, chemical compatibility studies, and sterilization validation to ensure reliable performance in the intended use environment.
Factory Show:
Our state-of-the-art medical manufacturing facility houses dedicated cleanrooms (up to ISO Class 7) where our automated LSR injection molding cells operate. These closed-loop systems ensure precise, contaminant-free production of critical valve components. In-house precision mold making using CNC, wire EDM, and polishing ensures micro-tolerance cavities for consistent part geometry. The entire post-molding process, including deflashing, inspection, and packaging, is conducted within controlled environments. We utilize advanced metrology such as 3D optical profilers for surface analysis and custom-built test fixtures that simulate real-world pulsatile flow and pressure conditions. This integrated, validated environment is designed to produce reliable, traceable fluid path components for the global medical device industry.
