Bottle Nipples & Pacifiers
EN 1400 and FDA-compliant feeding components with 200-cycle boiling stability verified per batch.
Application Overview
Nipples and pacifiers are the most regulated silicone consumer parts in the world — and the most safety-critical. We produce food-grade LSR feeding components with verified low volatility, no taste transfer and pull-tested one-piece construction. Vent valve geometry, flow rates (S/M/L) and orthodontic shapes are all molded, never glued, so there is nothing to detach.
Technical Standards
- ✓EN 1400 (soothers for babies) full compliance including volatility ≤ 0.5%
- ✓FDA 21 CFR 177.2600 and German BfR XV recommendations
- ✓LFGB tested — no odor, no taste transfer
- ✓EN 71-3 migration screening for toy-adjacent SKUs
Manufacturing Process
One-piece LSR injection molding in medical-grade cleanroom tools; vent valves and multi-durometer zones are molded in a single cycle.
- Closed-loop material dosing prevents cross-contamination
- Flow-rate hole punching by tool-formed precision openings
- 200 °C post-cure stabilizes volatiles before packaging
- Food-grade packaging with lot-coded date marking
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
- 🔍Volatility content ≤ 0.5% per EN 1400, verified per batch
- 🔍Tension / pull test on teat and shield assembly
- 🔍200-cycle boiling stability test per lot
- 🔍Total migration ≤ 10 mg/dm² per EU 10/2011-style protocol
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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