The Challenge
The brand was launching a high-end silicone pacifier line targeting both EU and US markets. Their previous supplier’s samples collapsed at the tip after only 5 boiling cycles, and volatile matter tested at 0.62% — above the brand’s internal limit of 0.5%. Requirements: retain original shape after 200 boiling cycles, pass saliva-migration testing, and certify under both EN 1400 and FDA 21 CFR 177.2600.
Our Solution
We reformulated a platinum-cured LSR compound with low post-cure volatility, adjusted the wall thickness distribution in the mold design to reinforce the teat, and ran a 200-cycle boiling validation with third-party lab verification for volatility (final: 0.31%) and migration.
Results
- ✅ 200-cycle boiling test passed with zero deformation
- ✅ Volatile matter reduced from 0.62% to 0.31%
- ✅ EN 1400 + FDA 21 CFR 177.2600 both certified
- ✅ Volume production ramped within 6 weeks of tooling sign-off
Have a similar challenge?
Send us your failed parts, test reports or just the requirement — we will give an engineering assessment free of charge.
Talk to an Engineer →