ISO 9001 & ISO 13485 Certified · FDA/USP Class VI · Made in China

Liquid Silicone Rubber (LSR) Injection Molding — Medical, Automotive & Electronics

SSP Precision delivers fully automated two-component liquid silicone rubber molding with FDA/USP Class VI compliance, ±0.003in dimensional tolerance, and temperature resistance from −70°C to +230°C — shipped from China to over 30 countries with complete ISO documentation.

±0.003in
Precision Grade
−70/+230°C
Temp Range
<30sec
Cycle Time
USPVI
Medical Grade
About LSR Molding

What Is Liquid Silicone Rubber Injection Molding?

Liquid Silicone Rubber (LSR) injection molding is a highly automated manufacturing process in which two-component platinum-catalyzed silicone (Part A + Part B) is precisely metered, mixed at a 1:1 ratio, and injected into a heated mold — where it vulcanizes in under 30 seconds into a finished elastomeric part.

Unlike thermoplastic injection molding, LSR is processed at room temperature and vulcanizes in a heated mold — the inverse of conventional molding. This enables sub-30-second cycles with zero post-processing, exceptional biocompatibility, and dimensional consistency exceeding ±0.005mm across millions of production cycles.

FDA/USP Class VI compliant: ISO 10993 biocompatibility tested — direct contact with body fluids and tissue
Temperature range −70°C to +230°C: Stable across cryogenic to high-heat sterilization environments
±0.005mm tolerance: Maintained across 1,000,000+ production cycle validation runs
Fully automated 2K system: Eliminates human contamination — <30s cycle, 98%+ material utilization
Multi-shore hardness: Shore 20A–80A achievable — single-component flexibility without secondary assembly
Liquid silicone rubber LSR injection molding process at SSP Precision China
20A–80A
Shore hardness range
<30 sec
Automated cycle time
LSR Manufacturing Workflow

SSP's Automated LSR Injection Molding Process — 8 Stages

A fully documented, ISO 13485-compliant 8-stage production workflow — from raw material verification through global delivery with complete quality documentation.

01

Material Verification

Incoming LSR compound lot testing — Shore hardness, viscosity, catalyst ratio, and biocompatibility traceability. Full material COC retained per ISO 13485.

02

DFM & Mold Design

LSR-specific DFM analysis: parting line, gate type (cold runner preferred), draft angles, vent placement, and mold flow simulation for uniform fill and cure.

03

Precision Tooling

S136 stainless steel molds for medical-grade LSR — polished to Ra ≤4μin, with conformal cooling and vacuum-vented cavities. Mold rated 1M+ cycles.

04

2-Component Metering

Precision dosing pumps deliver Part A and Part B at exactly 1:1 ratio (±0.5%) — zero contamination in a fully closed, automated material handling system.

05

Static Mixing & Injection

Disposable static mixer blends components completely before delivery to a cold runner system. Injection pressures 500–1500 bar with <0.01mm/s velocity control.

06

Vulcanization (Cure)

Heated mold (150–200°C) platinum-catalyzes rapid vulcanization in 15–30 seconds. Conformal cooling stabilizes shrinkage for dimensional consistency.

07

CMM Quality Inspection

100% first article dimensional verification by CMM (±5μm resolution). Shore hardness, tensile, tear strength, and biocompatibility testing per ASTM standards.

08

Certified Global Delivery

ISO 13485 traceability documentation, FAIR reports, COC, MSDS, sterilization validation data — worldwide delivery within committed lead times.

Materials & Precision

LSR Grades & Dimensional Tolerances

SSP Precision processes the complete spectrum of LSR grades — from standard industrial silicones to medical-grade platinum-cure compounds — with documented tolerance compliance across every grade.

Medical & Pharmaceutical Grade
FDA 21 CFR 177.2600USP Class VIISO 10993Dow SILASTIC™ MEDWacker ELASTOSIL® LRShin-Etsu Medical LSR
Optical & Transparent LSR
Optical-grade transparentSelf-bonding optical LSRUV-stable clear LSRLow refractive index
Specialty Functional Grades
Electrically conductive LSRThermally conductive LSRFlame-retardant (UL 94 V-0)Self-adhesive LSRFluorosilicone (FVMQ)
Shore Hardness Range
Shore 10AShore 20AShore 30AShore 40AShore 50AShore 60AShore 70AShore 80A
Two-Shot (2K) Substrate Materials
PC (polycarbonate)PA6 / PA66 (nylon)ABSPP (primed)PBTStainless steel insertsAluminium inserts
Certifications by Grade
FDA 510(k) compatibleISO 10993-5 cytotox.USP <87> in-vitroREACH compliantRoHS compliantNFPA 701 flame

LSR Dimensional Tolerances

±0.003inMedical/precision grade positional tolerance (CMM verified)
±0.005mmStandard dimensional tolerance across 1M+ cycle validation
0.15mmMinimum wall thickness (medical-precision grade tooling)
0.2mmMinimum undercut capability (precision mold design)
Ra 16μinSurface finish — medical grade (white light interferometry)
<30 secAutomated production cycle time (standard grade)

Shrinkage & Dimensional StabilityLSR exhibits predictable isotropic shrinkage of 2.5–3.5% (grade-dependent). SSP compensates with precision mold geometry and validated process parameters — achieving ±0.005mm dimensional consistency across full production runs, documented on SPC control charts.

Technical Specifications

LSR Molding Performance Specifications — Standard vs. Medical Grade

Industry-validated performance data for standard and medical/precision LSR grades — all parameters verified by ASTM-standard testing methods with independent laboratory documentation.

Category Parameter Standard LSR Grade Medical / Precision Grade Test Method
MaterialTensile Strength8–12 MPa10–15 MPaASTM D412
Tear Strength25–50 N/mm40–60 N/mmASTM D624
Elongation at Break400–600%600–800%ASTM D412
Hardness (Shore A)20–70A30–80AASTM D2240
ThermalOperating Temp Range−60°C to +200°C−70°C to +230°CASTM D1329
Thermal Conductivity0.2–0.3 W/mK0.15–0.25 W/mKASTM E1461
Compression Set (22h/175°C)15–25%10–15%ASTM D395
DimensionalPositional Tolerance±0.010in±0.003inCMM (5μm)
Surface Finish (Ra)32–64 μin16–32 μinWhite Light Interferometry
Min. Wall Thickness0.3 mm0.15 mmMicro-CT Scanning
BiocompatibilityFDA/USP Class VINoYesISO 10993
CytotoxicityPassUSP <87>
SterilizationAutoclave (121°C)100 cycles300+ cyclesAAMI ST108
EtO / Gamma / E-beamCompatibleValidatedISO 11135
ElectricalVolume Resistivity10¹⁴ Ω·cm10¹⁵ Ω·cmASTM D257
Dielectric Strength18–22 kV/mm20–25 kV/mmASTM D149
All performance data is based on SSP Precision production testing and published material supplier datasheets (Dow, Wacker, Shin-Etsu). Medical-grade parameters validated per ISO 10993 by accredited third-party testing laboratory. Contact our engineering team for grade-specific datasheets.
Why LSR Molding

Five Technical Advantages of LSR Injection Molding

Each advantage is quantified — SSP Precision provides the measurement data to support every claim in your engineering specification, regulatory submission, or supplier qualification audit.

01
Unmatched Dimensional Precision
LSR's controlled vulcanization shrinkage (2.5–3.5%, grade-specific and isotropic) enables dimensional tolerances that thermoplastic elastomers cannot match. CMM-verified ±0.003in positional accuracy documented across 500,000-cycle production validation runs at SSP.
±0.003in
02
Superior Material Performance
Medical-grade LSR maintains functional properties from −70°C (cryogenic storage) to +230°C (steam autoclave sterilization) — a 300°C operational window no thermoplastic elastomer achieves. Tensile strength 10–15 MPa with 600–800% elongation at break (ASTM D412).
300°C range
03
Optimized Production Efficiency
Fully automated 2-component dosing eliminates manual material handling — achieving <30-second cycle times with 98%+ material utilization via cold runner systems. Zero post-cure required for standard grades; dimensional stability achieved on ejection.
<30 sec
04
Full Biocompatibility & Regulatory Compliance
Medical-grade LSR processed at SSP carries FDA 21 CFR 177.2600, USP Class VI, and ISO 10993 documentation — covering cytotoxicity (USP <87>), sensitization, intracutaneous reactivity, and systemic injection testing. Available for FDA 510(k) technical files.
FDA Class VI
05
Design Flexibility
LSR's low viscosity (1,000–1,000,000 mPa·s) enables filling of features <0.2mm — micro-channels, under-0.3mm walls, and complex undercuts achievable without secondary assembly. Multi-color and multi-durometer parts produced in single automated operations.
<0.2mm
06
Advanced Process Control
Real-time monitoring of injection pressure (500–1500 bar), mold temperature (±0.5°C), cure time (±0.5s), and material dosing ratio (±0.5%) — closed-loop control delivering 99.5%+ first-pass yield across validated medical production runs at SSP Precision.
99.5%+ yield
SSP Precision LSR molding expertise and manufacturing facility in China
15+
Years LSR manufacturing expertise
ISO 13485
Why Choose SSP Precision

China's LSR Molding Specialist — Global Standards, China Efficiency

SSP Precision combines 15+ years of LSR manufacturing expertise with ISO 13485-certified quality management, dedicated 2-component automated equipment, and a full metrology lab — delivering documented medical-grade LSR components to clients across 30+ countries.

ISO 13485:2016 Medical QMS
Full medical device quality management — lot traceability from raw material to delivery, process validation (IQ/OQ/PQ), and FDA-audit-ready documentation.
Dedicated 2K LSR Equipment
Specialized 2-component liquid silicone injection presses — not converted thermoplastic machines. Dedicated dosing pumps, static mixers, and cold runner systems for clean LSR production.
S136 Stainless Steel Tooling
LSR-optimized S136 stainless molds resist silicone corrosion — cold runner gates, vacuum venting, and conformal cooling. Tooling rated for 1,000,000+ production cycles.
China-Based, Worldwide Delivery
30+ countries served. Full export documentation, HS code classification, and international logistics coordination — certified LSR parts arrive on time with complete quality records.
Full-Service LSR: Prototype to Production
DFM consultation, mold design, T1 samples, process validation, production, and supply chain management — complete LSR manufacturing service from a single China-based partner.
Industries & Applications

LSR Injection Molding Applications by Industry

SSP Precision's LSR molding capability serves six primary industry verticals — each with distinct material certification, dimensional accuracy, and regulatory compliance requirements.

01

Medical Devices

Catheter seals, respiratory masks, implantable-grade components, diagnostic membranes, drug delivery device valves — FDA/USP Class VI, ISO 10993-compliant with full sterilization validation.

02

Electronics & Connectors

IP67/IP68 sealing gaskets, cable harness grommets, EMI shielding pads, keyboard membranes, and switch actuators — LSR's dimensional stability ensures repeatable seal performance.

03

Automotive

Under-hood seals (−40°C to +200°C), sensor housings, vibration dampeners, LED headlight optics, HVAC system components — LSR's thermal stability and chemical resistance meet OEM specifications.

04

Baby & Consumer Products

Infant bottle nipples, pacifiers, breast pump components, food contact seals, cookware — FDA food-contact compliant, BPA-free, phthalate-free, and EN 1400/ASTM F406 tested.

05

Wearables & Healthcare

Smartwatch skin-contact bands, hearing aid domes, continuous glucose monitor (CGM) patches, and wearable sensor housings — skin-safe, hypoallergenic, dermatologically tested LSR grades.

06

Optical & Lighting

LED lens arrays, automotive headlight lenses, optical fiber protective coatings — optical-grade transparent LSR with <2% haze, maintained over 10,000 hours UV aging per ISO 4892.

SSP HQ USA Europe Australia Japan
Global LSR Supply

Medical-Grade LSR Made in China. Delivered Worldwide.

SSP Precision's China-based LSR facility combines ISO 13485 quality management with competitive China manufacturing costs — delivering certified medical and precision silicone parts to medical device OEMs, automotive Tier 1 suppliers, and electronics manufacturers in 30+ countries.

30+
Countries served
1M+
LSR cycles validated
99.5%
First-pass yield
15+
Years LSR experience
USAGermanyUK FranceJapanSouth Korea AustraliaCanadaNetherlands SwitzerlandSweden+ More
Start Your LSR Project

Ready to Source Medical-Grade LSR Molded Parts from China?

Submit your LSR part drawing or specification. SSP Precision's application engineering team responds within 24 hours with material recommendations, DFM feedback, a competitive quote, and — for medical applications — a preliminary biocompatibility compliance summary at no extra charge.

ISO 9001 & 13485
24-Hour Quote
FDA/USP Class VI
FAIR Documentation
30+ Countries