LSR Injection
Silicone Valve Seal for US Medical Device OEM
ISO 13485 compliant | Class 100 cleanroom | FDA 21 CFR 177.2600
Challenge
A US medical device manufacturer needed a biocompatible LSR valve seal with tight dimensional tolerance (±0.05mm). Previous supplier had a 15% defect rate due to flash and voids. FDA compliance was non-negotiable.
Our Solution
- DFM review identified gate location optimization to reduce void formation by 92%
- Recommended medical-grade LSR (Shore A 50) with FDA master file documentation
- Built Class 100 cleanroom production cell for this project
- Implemented 100% visual inspection + CMM spot check on critical dimensions
Results
“The engineering feedback before quoting saved us from repeating our previous supplier’s mistake. The DFM report alone was worth the engagement.”
Compression Molding
EPDM Engine Bay Gaskets for German Tier-2 Supplier
Automotive-grade EPDM | -40°C to +125°C | IATF 16949 process control
Challenge
German automotive supplier required EPDM gaskets meeting SAE J200 / ISO 143-1 specifications. Temperature range -40°C to +125°C. Previous China source failed heat aging tests at 96 hours.
Our Solution
- Custom-compounded EPDM formulation with peroxide cure system for superior heat resistance
- Optimized mold design with cold runner system to reduce material waste by 23%
- PPAP Level 3 submission with full SPC data on critical dimensions
- Heat aging testing at 125°C/168hr — compression set improved from 28% to 15%
Results
“THOR-SOFT’s compound lab solved a problem three other suppliers couldn’t. Their PPAP package met our German customer’s requirements without revision.”
Overmolding
Silicone Overmold on PCB Assembly for Smart Home Device
LSR over PC+ABS | UL94 V-0 | IP65 waterproof seal | RoHS compliant
Challenge
US smart home startup needed waterproof overmolded housing for PCB assembly. Required IP65 rating, no component damage during molding, and fast prototyping cycle for product launch deadline.
Our Solution
- Low-temp LSR molding process (< 170°C) to protect sensitive electronic components
- Mold design with insert fixtures to prevent board flexing during injection
- Rapid tooling: T1 samples delivered in 8 days from drawing approval
- IP65 water ingress testing passed on first trial
Results
“We were told overmolding onto populated boards wasn’t possible without damaging components. THOR-SOFT proved otherwise.”
HTV Compression
FDA-Grade Silicone Baby Bottle Nipple for EU Brand
Challenge
EU baby products brand needed food-grade silicone nipples meeting strict EU safety standards (EN 14350-2). Required LFGB certification, migration testing, and consistent Shore A hardness (±2 tolerance).
Our Solution
- Selected platinum-cure HTV silicone with full FDA/LFGB dual certification
- Tight process controls on mixing ratio and curing time for hardness consistency
- Dedicated production line with color-coded molds to prevent cross-contamination
- Third-party migration testing coordinated through accredited EU lab partner
Results
“The LFGB documentation was comprehensive and passed EU import inspection without any questions. Our QA team was impressed.”
Extrusion
Custom FKM O-Ring Cord for Oil Field Equipment
FKM (Viton) Grade 75 | HNBR blend option | -30°C to +200°C | API Spec Q1 traceability
Challenge
Oil field equipment OEM needed custom-extruded FKM cord for dynamic sealing application. Standard off-the-shelf cord didn’t meet the required durometer or temperature range for sour gas environment.
Our Solution
- Custom FKM compound blended with HNBR for enhanced low-temp flexibility (-30°C)
- Precision extrusion die designed for ±0.1mm diameter tolerance on 8mm cord
- Full batch traceability: raw material lot → extrusion batch → coil ID → shipment
- NACE MR0175 / ISO 23936-2 sour gas compatibility verified via third-party test
Results
“The traceability system exceeded our API audit requirements. Every coil can be traced back to the exact rubber batch.”
Compression + Extrusion
Complete Silicone Bakeware Set for Amazon Private Label
Food-grade HTV | FDA/LFGB/NSF certified | Panton/RAL color match | Multi-component kit
Challenge
Amazon private label seller needed complete bakeware set (mat + spatula + pastry brush + cupcake molds) in matching Pantone color. Tight timeline: 45 days from order to FBA warehouse receipt.
Our Solution
- Color-matched to Pantone 17-1546 (Living Coral) using spectrophotometer verification
- Parallel tooling: 4 sets of tools built simultaneously across 2 processes (compression + extrusion)
- FBA-compliant packaging: polybag + Amazon label + carton ready for direct fulfillment
- Pre-shipment inspection with photo/video report before container loading
Results
“From drawing to Amazon FBA warehouse in 42 days with perfect color match. This is what a true manufacturing partner looks like.”
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