Valves & Seals for Devices
Umbrella, duckbill and slit valves plus device seals with repeatable crack-pressure performance.
Application Overview
Fluid control valves are the heart of infusion sets, urology devices and diagnostic equipment. We mold LSR umbrella, duckbill and slit valves where crack pressure and flow rate must repeat within narrow windows, lot after lot. Knife-edged slits are formed without secondary cutting to avoid burrs that could shed particles. Device O-rings and seals are supplied with full dimensional reports.
Technical Standards
- ✓ISO 10993 biocompatibility and USP Class VI material grades
- ✓ISO 13485-aligned manufacturing with DHR per lot
- ✓Crack-pressure and flow-rate specifications defined per customer drawing
- ✓FDA 21 CFR 177.2600 compliant compounds for fluid-path parts
Manufacturing Process
Valves are LSR injection molded in flashless, cold-deck tools that keep the critical slit geometry burr-free.
- Slit and membrane thicknesses controlled at ±0.02 mm by tool steel insert precision
- No post-molding knife trimming — the slit is formed by the tool itself
- Post-cure cycle tuned to stabilize durometer and crack pressure
- Cleanroom molding and packaging prevent particle contamination of fluid paths
Quality Inspection
- 🔍100% visual inspection (flash, short-shot, contamination) before packing
- 🔍Dimensional verification against approved drawing; FAI report on first shipment and after any tooling change
- 🔍Hardness per ASTM D2240 (Shore A) on every batch
- 🔍Lot traceability: material batch, cure records and operator logged for every carton
- 🔍Crack-pressure / flow-rate functional test on sampled parts per lot
- 🔍Slit and membrane thickness verification on molded samples
- 🔍Leak-back test for check-valve function
After-sales & Support
Every order ships with a Certificate of Conformance, First Article Inspection report and lot traceability records.
- Warranty: 12 months against material and workmanship defects
- Response: engineering reply within 24 hours, 8D report for confirmed quality issues
- Remedy: free replacement or credit for non-conforming batches; expedited re-shipment at our cost
- Support: free design-for-manufacturing review, material selection advice and sample policy for evaluation
- Recall readiness: full batch traceability enables targeted containment within 48 hours
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