Custom Medical Grade Liquid Silicone Rubber Parts

# Custom Medical Grade Liquid Silicone Rubber Parts

Product Overview

Custom Medical Grade Liquid Silicone Rubber (LSR) Parts are precision-engineered elastomer components manufactured to meet the strict regulatory and performance requirements of the medical and healthcare industries. Unlike off-the-shelf rubber products, our custom LSR parts are tailored to your exact design specifications, material requirements, and end-use functional needs, enabling seamless integration into complex medical devices, diagnostic equipment, and patient care applications.

Our custom LSR manufacturing process combines high-precision liquid injection molding (LIM) with rigorous material traceability, producing parts that exhibit exceptional biocompatibility, thermal stability, chemical resistance, and elastic recovery. We support projects from low-volume prototyping to high-volume mass production, with full design assistance to optimize part performance and manufacturability without compromising compliance with global medical industry standards. Whether you need a single complex prototype or millions of production-grade components, our custom LSR solutions deliver consistent quality and performance that medical device manufacturers rely on.

Technical Specifications

Material Properties

All custom LSR parts are produced from 100% pure platinum-cured liquid silicone rubber, free of organic peroxides, phthalates, BPA, and other toxic additives common in conventional rubber products. Key material properties include:

• Polymer base: Polydimethylsiloxane (PDMS)
• Curing system: Platinum (addition) curing
• Biocompatibility classification: ISO 10993-1 / USP Class VI
• Sterilization compatibility: Autoclave, ethylene oxide (EtO), gamma irradiation, e-beam
• Chemical resistance: Resistant to body fluids, common disinfectants (ethanol, isopropyl alcohol, chlorhexidine), aldehydes, and most polar solvents
• Operating temperature range: -40°C to 200°C (-40°F to 392°F) continuous service
• Surface finish options: Matte, semi-gloss, glossy, or micro-textured per design requirements

Physical Performance

Physical performance parameters can be adjusted per application requirements, with standard ranges as follows:

All physical properties are tested and validated per batch to ensure consistency with your project requirements.

Process Parameters

Our custom LSR parts are produced via precision liquid injection molding (LIM), with controlled process parameters to ensure dimensional accuracy and material consistency:

• Injection pressure: 50 bar to 150 bar, adjusted per part geometry
• Mold temperature: 160°C to 190°C
• Curing time: 30 seconds to 3 minutes, depending on part thickness
• Maximum part dimension: 400 mm × 400 mm × 100 mm
• Minimum wall thickness: 0.5 mm
• Typical dimensional tolerance: ±0.05 mm for parts <50 mm; ±0.1% of nominal dimension for parts >50 mm (tighter tolerances available upon request)
• Post-curing: Optional 2-hour post-cure at 150°C for low-volatility applications

Product Advantages

1. Full Regulatory Compliance for Medical Applications

Our custom LSR materials are sourced from ISO 13485-certified raw material suppliers, with full traceability from resin batch to finished part. All materials meet US FDA 21 CFR Part 177.2600 requirements for food and medical contact, and are tested for cytotoxicity, irritation, and sensitization per ISO 10993 standards. This eliminates compliance risks for your medical device submissions to the FDA, CE, and other global regulatory bodies.

2. Unlimited Design Flexibility for Complex Geometry

Liquid injection molding of LSR enables production of extremely complex geometries, thin walls, undercuts, and overmolded assemblies that are not possible with conventional compression molded silicone. We support overmolding onto rigid substrates including PC, ABS, PEEK, stainless steel, and titanium, creating fully integrated multi-material components that reduce assembly costs and improve device reliability.

3. Exceptional Biocompatibility and Patient Safety

Platinum-cured LSR is non-toxic, non-irritating, and non-sensitizing to human tissue, making it ideal for long-term and short-term body contact applications. Unlike peroxide-cured silicone, our LSR contains no residual byproducts from curing, eliminating the risk of leachable contaminants that can cause adverse patient reactions. The material is also naturally hypoallergenic, making it suitable for sensitive skin applications.

4. Excellent Durability and Sterilization Resistance

Custom LSR parts retain their elastic properties, tensile strength, and dimensional stability after repeated sterilization cycles, with no cracking, brittling, or degradation over the product lifecycle. The material is resistant to lipid absorption from body fluids, preventing swelling or performance loss in long-term implantable or chronic care applications.

Applications

Custom medical grade LSR parts are used across a wide range of medical and healthcare applications, including:

• Implantable Devices: Orthopedic spacers, breast implant shells, pacemaker lead insulators, vascular graft seals, and cosmetic implant components for long-term and short-term implantation
• Medical Devices & Diagnostics: Seals and gaskets for syringes, insulin pumps, oxygen regulators, and diagnostic analyzers; syringe plunger tips, valve diaphragms, and drug delivery system components
• Patient Care Products: Mask seals for CPAP and non-invasive ventilation, wound care dressings, catheter cuffs, ostomy bag seals, and wearable sensor adhesive pads
• Surgical Instruments: Instrument grip covers, sterile barrier seals, laparoscopic port seals, and retractor components
• Dental Applications: Impression trays, mouth guards, orthodontic aligner components, and dental implant healing caps

Selection Guide

Hardness Selection

Choose LSR hardness based on your application's functional requirements:

• 10 Shore A to 30 Shore A: Soft, conformable applications such as mask seals, wound contact pads, and implantable cushions
• 30 Shore A to 50 Shore A: General purpose applications including gaskets, valve diaphragms, and overmolded grips
• 50 Shore A to 70 Shore A: High-wear applications requiring structural support, such as syringe plunger tips and connector seals
• 70 Shore A to 80 Shore A: Rigid silicone components requiring high dimensional stability, such as structural spacers and instrument components

Size Specifications

We accommodate all part sizes within our manufacturing capabilities:

• Micro components: Minimum dimension 0.5 mm for microfluidic and implantable applications
• Large components: Up to 400 mm × 400 mm × 100 mm for large device seals and patient interface components
• We support custom batch sizes from 1 part for prototyping up to 10,000,000+ parts annually for mass production.

Material Grade

Select the appropriate material grade based on your application's exposure requirements:

• Short-term contact grade (<30 days contact): Suitable for external patient care products, surgical instruments, and diagnostic equipment; meets ISO 10993-1 and USP Class VI requirements
• Long-term contact grade (>30 days contact / implantable): Low-volatility, extra-purified LSR for implantable devices and long-term wearable applications; includes additional leachable and extractable testing
• Radio-opaque grade: LSR loaded with barium sulfate for X-ray visibility in implantable and interventional device applications

Quality Assurance

We maintain a fully ISO 13485:2016 certified quality management system for all custom medical LSR part production, with end-to-end quality control at every stage of manufacturing:

• Raw material incoming inspection: All raw silicone batches are tested for hardness, specific gravity, and biocompatibility documentation before production
• In-process quality control: Dimensional inspection, surface finish check, and curing validation for every production run
• Final lot testing: Optional biocompatibility testing, leachable testing, and sterility testing available per customer requirements
• Full documentation: Each production lot includes a Certificate of Analysis (CoA), material traceability report, and compliance statement for regulatory submissions
• Certifications: All materials comply with ISO 10993-1, USP Class VI, FDA 21 CFR Part 177.2600, and REACH / RoHS requirements. CE marking support is available for finished device integrators.

Our quality team works closely with your engineering and regulatory teams to ensure all custom parts meet your specifications and support successful regulatory approval of your medical device.