Product Description:
Our custom medical-grade silicone umbrella check valves ensure reliable, unidirectional fluid control in critical applications. Precision molded from USP Class VI compliant silicone, they offer consistent cracking pressure, exceptional chemical resistance, and autoclavable durability for medical and laboratory devices.
Basic Information:
| Attribute | Specification |
|---|---|
| Place of Origin | Xiamen, China |
| Shape | Umbrella/Diaphragm, Custom Designs |
| Brand Name | OEM |
| Minimum Order Quantity (MOQ) | Project-based, consultative |
| Material | USP Class VI, Platinum-Cure Silicone |
| Logo | Laser Etching (Biocompatible) |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, USP Class VI, RoHS |
| Packaging | Cleanroom, Custom (Trays, Pouches) |
| OEM Services | Full Design & Regulatory Support |
| Primary Use | Medical Devices, Fluid Management, Lab Equipment |
| Sample Lead Time | 10-15 business days |
| Sample Availability | With NDA & Project Brief |
| Production Lead Time | 30-45 business days (Validated Process) |
Quality Assurance:
Quality assurance for our medical-grade check valves is governed by a stringent, ISO 13485 compliant quality management system. It begins with the validation of raw material certifications (USP Class VI, FDA) and full traceability. Precision LSR injection molding is performed in a controlled environment, with critical process parameters (CPPs) meticulously monitored and documented to ensure batch-to-batch consistency. Each valve undergoes 100% functional testing for specified cracking pressure and leak-tight sealing using calibrated pressure decay testers. Dimensional inspection via optical comparators, material biocompatibility testing, and rigorous cleanroom assembly and packaging ensure the valves meet the exacting standards required for medical and diagnostic fluid path applications.
Why Choose Us?
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Expertise in Medical Fluid Path Components: We specialize in the design and manufacture of critical silicone valves for medical devices, with deep understanding of regulatory requirements (ISO 13485, FDA) and performance needs in fluid handling systems.
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Co-Development for Application-Specific Performance: We partner with you to engineer valve geometry, durometer, and lip design to achieve precise cracking pressure, flow characteristics, and chemical compatibility for your specific fluid and device.
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Regulatory-Ready Manufacturing & Documentation: Our ISO 13485 certified facility provides full Device History Records (DHRs), lot traceability, and validation support (IQ/OQ/PQ) to streamline your regulatory submission and audit processes.
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Rigorous, Application-Validated Testing: Beyond standard QC, we perform extensive validation testing, including lifetime cycle fatigue, exposure to various chemicals/sterilants (ETO, autoclave), and functional testing under simulated use conditions.
Factory Show:
Our medical device manufacturing facility features dedicated, certified cleanrooms (ISO Class 8) where our automated LSR injection molding cells produce these critical components. Mold fabrication utilizes high-precision CNC and wire EDM to achieve the exacting tolerances required for consistent valve performance. The entire production workflow—from molding and demolding to final inspection—is conducted in a controlled particulate environment. We employ advanced metrology such as vision measurement systems and micro-CT scanning for non-destructive internal structure analysis. Specialized test stands simulate real-world pressure cycles and fluid exposure. This integrated, controlled environment is designed to manufacture reliable, traceable components that meet the highest standards of the medical device industry.
