Overview
Our Customized Medical-Grade 10.5mm LSR Silicone Valves with a 3mm cross-slit are engineered for reliable, sterile, mess-free one-way dispensing in medical, pharmaceutical, and clinical packaging. Manufactured from ISO-10993-tested, medical-grade liquid silicone rubber (LSR), these 10.5mm valves deliver precise opening pressure, rapid resealability, and absolute backflow prevention. Produced by automated LSR injection molding, micro-precision cross-slit cutting, and cleanroom assembly, they are optimized for compatibility with sterile closures and caps used in dosing, irrigation, and single-use fluid delivery systems.
Basic Information
| Attribute | Details |
|---|---|
| Place of Origin | Xiamen, China |
| Brand Name | OEM / Custom Branding |
| Product Type | Medical-grade one-way silicone valve |
| Nominal Diameter | 10.5 mm |
| Slit Type | 3.0 mm cross-slit (micro-cut) |
| Material | Medical-grade LSR (ISO 10993, USP VI options) |
| Hardness | Shore A 35–60 (customizable) |
| Tolerance | ±0.02 mm (dimensional) |
| Molding Process | Automated LSR injection molding + laser/micro slit cutting |
| Surface Finish | Smooth, non-stick, medical polish |
| Certifications | ISO 9001, ISO 13485, FDA, RoHS; biocompatibility per ISO 10993 |
| MOQ | Small orders accepted |
| Sample Lead Time | 5–7 business days |
| Production Lead Time | 20–25 business days |
| Packaging | Sterile packaging options (EtO/gamma compatible) or bulk per customer spec |
| Primary Use | Medical dosing caps, irrigation/irrigator bottles, drug delivery closures |
Key Benefits
- Medical-Grade Safety: ISO 10993-tested LSR and optional USP Class VI grades for extended skin/medical contact.
- Reliable One-Way Flow: 3mm cross-slit ensures immediate open/close response, preventing drip, backflow, and contamination.
- Precise Performance: Tight dimensional control (±0.02 mm) and calibrated opening pressure for consistent dosing.
- Sterilization Compatible: Withstands EtO, gamma, and autoclave cycles when specified materials and process controls are used.
Quality Assurance
We apply a rigorous QA program tailored for medical components: incoming LSR raw material traceability and spectrochemical verification; full-trace lot control; dimensional inspection with ZEISS-class CMM and high-resolution optical projectors; slit geometry verification using micro-imaging and laser profiling; mechanical testing including opening pressure, compression set, tensile/tear strength, and fatigue life (actuation cycle testing up to specified millions of cycles). Biocompatibility and extractables testing are available per ISO 10993 panels; sterilization validation and post-sterilization integrity testing are performed per customer requirements. All production and inspection records are maintained for full traceability.
Factory Capabilities
Our state-of-the-art manufacturing facility combines advanced CNC machining, Mirror EDM, conventional EDM, and slow-speed high-precision wire cutting to produce highly accurate mold tooling, supported by 15 rubber compression presses and two LSR injection molding machines for optimized throughput and efficiency. We maintain rigorous quality control with 3D projectors, sealing testers, Shore durometers, and elasticity gauges operated by experienced, certified QC technicians, and our processes are fully certified to ISO 9001 and IATF 16949. Automated systems—AutoDryers, high-speed doming machines, and precision die-cutters—further streamline production, preserve tight tolerances, and ensure consistent, high-performance components across every run.
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