Fecision's LSR injection molding cell operates within a Class ISO 7 / 100,000 cleanroom, producing million+ precision silicone components per month for medical device OEMs, electronics manufacturers, and industrial customers.
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What Is LSR Injection Molding
LSR injection molding injects a two-part liquid silicone compound (base + catalyst in 1:1 ratio) into a heated mold where it vulcanizes into a permanent, cross-linked elastomer. Unlike thermoplastics that can be remelted, LSR's thermoset nature ensures dimensional stability and performance retention across extreme temperatures (-60°C to 230°C).
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Fecision's Service
At Fecision, our ISO 13485:2016 quality management system governs every medical program — from incoming material certification through production, first-article CMM inspection (Cpk ≥1.67 on critical features), and full batch traceability. PPAP submission support is available for medical device customers requiring supplier qualification documentation.
What is Liquid Silicone Rubber (LSR)
LSR Materials for Injection Molding
Liquid Silicone Rubber (LSR) is a high-purity, versatile thermoset elastomer renowned for its exceptional performance characteristics. It is a two-part, platinum-cured silicone system (typically an A component and a B component mixed in a 1:1 ratio) that, once cured, offers a unique combination of properties making it an ideal choice for a vast array of demanding applications.
Outstanding thermal stability
Excellent chemical resistance
Inherent biocompatibility and hypoallergenic nature
Superior durability and tear strength
Electrical insulation properties
Can be easily pigmented for color-coding or aesthetic purpose
Property
Typical Range
Standard
Hardness (Shore A)
10 – 80
ISO 7619-1
Tensile Strength
7 – 12 MPa
ISO 37
Elongation at Break
400% – 800%
ISO 37
Tear Resistance
17 – 47 kN/m
ISO 34-1
Density
1.11 – 1.20 g/cm³
ISO 2781
Temperature Range
-60°C to +230°C
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LSR Injection Molding Expertise
Fecision's LSR Injection Molding Capabilities
We are equipped to handle projects of varying complexity and scale, ensuring optimal outcomes that meet your specific application needs.
Advanced Equipment
Our workshop is equipped with high-precision LSR injection molding machines (50-300 ton capacity), capable of handling a wide range of part sizes and complexities. We utilize automated material delivery systems and robotic part removal for consistent, efficient production.
Material Expertise
Our engineering team possesses extensive expertise in selecting and processing a diverse portfolio of LSR grades to match the unique demands of each application. This includes medical-grade (USP Class VI), FDA-compliant, conductive, and self-lubricating LSR materials.
Precision Tooling
Fecision boasts comprehensive in-house mold design and manufacturing capabilities specifically tailored for LSR injection molding. Our tooling achieves 0.01mm tolerance capability with both hot and cold runner systems available.
Value-Added Services
Our services include post-molding operations like post-curing for enhanced properties, precision deflashing to remove any residual material, custom packaging solutions to protect your parts, and assembly services.
Supplier Qualification Support
For components requiring pre-sterilization packaging qualification, Fecision provides cleanroom packaging validated per ISO 11607.
Sterilization compatibility: Fecision medical LSR components have been validated for EtO, gamma irradiation, e-beam, and autoclave (134°C steam) sterilization methods.
Packaging options: Sterile barrier pouches and trays validated for the customer’s specified sterilization method. Accelerated aging per ASTM F1980 and distribution simulation per ASTM D4169 are available as value-added services for programs requiring complete packaging validation documentation.
Cleanroom Packaging and Sterilization Support
Fecision is designed to pass your supplier qualification audit.
Our ISO 13485:2016 QMS documentation, equipment calibration records, process validation files, and environmental monitoring logs are maintained audit-ready at all times. What we make available for supplier qualification:
ISO 13485:2016 certificate and scope statement
Quality Manual and relevant SOPs
IQ/OQ/PQ reports for customer-specific processes (under NDA if required)
Equipment calibration and preventive maintenance records
Environmental monitoring data (cleanroom particle counts, temperature/humidity logs)
LSR Two-Shot Overmolding and Multi-Material Components
Fecision produces combination components where LSR is directly molded onto thermoplastic substrates in a single production cell — eliminating secondary assembly and adhesive bonding steps.
PA6, PA66, PBT, PC, and other engineering plastics validated for LSR adhesion.
Substrate surface activation is specified based on the material pairing and validated before production release.
Strength
Two-shot overmolded components eliminate separate bonding operations · adhesive outgassing risk in cleanroom environments · delamination failure modes in service · BOM complexity and assembly labour cost.
Applications
Soft-seal medical connector housings where silicone seals onto rigid PC or PA bodies
Wearable medical device interfaces with LSR skin-contact layer on rigid thermoplastic backing
Audio and tactile button assemblies for medical devices and electronics.
Fecision LSR Parts Production Equipment
Our dedication to quality is validated by precise, automated equipment built for repeatable LSR production.
Rubber Mixing Machine
Specs & Model: XK-300X700
Capacity: 70 ton
LIM Machine
Brand: Kraton Machinery
Capability: 1560w pcs/month
Pneumatic Punching Machine
Specs & Model: 203-125*100
Capacity: 1500w pcs/month
Automatic Deburring Machine
Brand: Desrui
Capability: 12000w pcs/month
Industrial Oven
Specs & Model: XHMO-3
Controlled post-curing
Applications & Industries Served
Fecision’s advanced Liquid Silicone Rubber (LSR) injection molding services cater to a diverse range of industries that demand high-performance, precision-engineered components. Our expertise in handling various LSR grades, including specialized medical-grade silicone (USP Class VI, biocompatible), coupled with our stringent quality control and extensive certifications (ISO 13485, IATF 16949, GMP Cleanroom), makes us a trusted partner for critical applications.
Medical & Healthcare
The inherent properties of LSR, such as its biocompatibility, chemical inertness, sterilizability, and durability, make it an ideal material for a wide array of medical devices and components. We manufacture parts that come into direct patient contact, as well as components for diagnostic and surgical equipment.
Applications
Seals, Gaskets, O-rings for diagnostic equipment, infusion pumps and respiratory devices; Diaphragms and Valves for fluid management systems, drug delivery devices and medical pumps. Parts for wearables, catheters, respiratory masks and dental applications; Surgical Instrument Components like Handles and Grips; Drug Delivery Components like Plungers and Stoppers.
LSR is increasingly used in electronics due to its soft-touch feel, durability, water resistance, and ability to be molded into intricate designs.
Applications
Keypads and Buttons for remote controls, mobile phones and other electronic devices; Seals and Gaskets for portable electronics, wearables and outdoor equipment; Protective Coverings and Casings for smart devices; Components for Wearable Technology like Wristbands Seals and Sensor Housings
Fecision serves various industrial sectors with LSR components designed for reliability and performance in demanding operational environments. These applications often require resistance to chemicals, extreme temperatures, and mechanical stress.
Applications
Seals, Valves, Membranes for industrial equipment, pumps and fluid handling systems; Gaskets and O-rings for a wide range of industrial machinery and processing equipment; Electrical Insulators and Connectors
Medical-grade liquid and solid silicone raw materials and color pastes
Capable of accommodating complex, irregular shapes and features with partial undercuts.
Intelligent Wearable Silicone Parts
Monthly production capacity: 1 million+ units.
Meets biocompatibility standards, hypoallergenic, compliant with skin irritation testing and relevant environmental regulations (e.g., FDA, LFGB).
Surface treatment options: Silk screening, laser engraving, color spraying, tactile coating, and UV surface modification.
High resistance to oxidation, aging, and corrosion.
Electrical Waterproof Silicone Parts
Two-shot Liquid Silicone Injection Molding
Mold Machining Precision: 0.001 mm
Mold Step Difference: 0.03 mm
Flash: 0.03 mm
IP7/IP8 Waterproof Rating
Precision Silicone Fittings
High-temperature resistance exceeding 150°C.
Silicone material suitable for new energy vehicles; Meets the UL94 V-0 flame retardancy standard.
High hardness and excellent scratch resistance.
High elasticity, offering superior sealing and insulation properties.
Adaptable to complex, irregular shapes and geometries involving undercuts.
Your Strategic Partner for LSR Injection Molding Success
The Fecision Advantage: Why Partner With Us?
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Quality & Certifications
Certifications: ISO 9001:2015 · ISO 13485:2016 · AS9100 Rev D · GMP 21 CFR Part 820 compliant cleanroom · QC080000 · ISO 14001:2015 · ISO 45001:2018. Quality metrics: Cpk ≥1.67 on critical-to-quality dimensions. Full batch traceability from raw material CoA to finished part release. PPAP submission support included with medical programs.
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Expertise & Experience
16+ years of LSR injection molding experience across medical, electronics, and industrial programs. Our engineers have qualified LSR processes for Class I, II, and III medical devices — including products requiring IQ/OQ/PQ process validation under ISO 13485 Clause 7.5.6. We design and manufacture 500+ molds annually.
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Facilities & Technology
Manufacturing: 10,000+ sqm facility. Class ISO 7 cleanroom for medical and regulated programs. 50+ injection molding machines including LSR-dedicated cells with integrated cold runner systems and automated metering. All-electric LSR injection presses eliminate hydraulic oil contamination risk.
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End-to-End Solutions
From DFM review to production release: Week 1–2 DFM review and material selection; Week 3–8 mould fabrication; Week 9–10 T0 trial and first-article CMM measurement; Week 11–12 OQ optimisation; Week 13–15 PQ validation; Week 16+ production release with full documentation package.
Rubber Mixing Dept
GMP Liquid Molding Workshop
Mold Workshop
Punching Trimming Dept
Quality Inspection Dept
Reliability Test Lab
Validated Performance, Guaranteed Quality
Quality & Certifications
Fecision has implemented a comprehensive quality assurance framework, underpinned by internationally recognized certifications and stringent internal processes, to ensure every part we deliver meets the highest standards of excellence, precision, and reliability.
Take the next step towards realizing your high-performance Liquid Silicone Rubber components. We are committed to providing tailored solutions that meet your specific application needs and project timelines.
What validation documentation do you provide for medical device programs?+
Every Fecision medical LSR program includes: IQ/OQ/PQ protocol execution and summary reports · CMM first-article report (Cpk ≥1.67 on critical features) · Material CoA per production lot · Full batch traceability records from raw material to part release.
What is your typical lead time from DFM approval to first article?+
For a standard medical LSR program: DFM review and approval (1–2 weeks) → mould fabrication (4–6 weeks) → T0 trial and first-article measurement (1–2 weeks). Total DFM-to-first-article: typically 8–12 weeks depending on part complexity.
Can you support regulatory audits during supplier qualification?+
Yes. Fecision welcomes customer quality audits as part of the supplier qualification process. Our ISO 13485:2016 QMS documentation, process validation records, and equipment calibration logs are maintained audit-ready. Remote documentation reviews and on-site audits can be scheduled with 2 weeks' notice.
Is LSR injection molding suitable for my production volume?+
LSR injection molding becomes most economical above approximately 15,000–30,000 parts per year, where automated cycle times (30–90 seconds) and zero flash trimming significantly reduce per-part cost vs. compression moulding. For lower volumes or development programs, we offer bridge tooling options.
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