Medical devices increasingly rely on silicone components that must perform reliably under continuous stress, sterilization cycles, and long-term patient contact. Our Medical LSR (Liquid Silicone Rubber) Molds are engineered for high-volume production of drug-delivery components, precision seals, valves, diaphragms, wearable parts, and other LSR molded medical devices that demand tight tolerances and fully controlled molding processes.
We design and manufacture liquid injection molding (LIM) tools specifically optimized for medical-grade silicone, ensuring stable cycle times, consistent part quality, and full compatibility with automated production environments.
Why LSR for Medical Components
Liquid Silicone Rubber has become a core material in medical applications due to its:
Excellent biocompatibility and ISO 10993 compliance
Wide temperature range for sterilization, autoclave, and long-term use
Low compression set for seals and drug-delivery functions
High transparency and purity
Chemical and UV stability
These characteristics make LSR molded parts ideal for devices where performance, safety, and regulatory alignment are critical.
Our Capabilities in Medical LSR Injection Molding
Medical silicone parts often require dimensional accuracy within ±0.02–0.05 mm.
Our tooling design focuses on:
Balanced cold-runner systems
Precision valve gating
Optimized venting to minimize flash
Temperature-stable mold steel selection
Controlled flow for micro-features and thin walls
This ensures consistent shot-to-shot repeatability, even for ultra-soft or transparent silicone grades.
Our LSR molds support continuous, automated production with:
Cold deck systems that reduce material waste
Seamless integration with A/B mixing units
Fast-curing silicone formulations for short cycle times
Full compatibility with robotic demolding
Molds designed for 24/7 mass production
For medical disposables-such as valves, seals, and drug-delivery components-these factors directly reduce unit cost and improve process stability.
Many medical device manufacturers require post-curing to further remove volatiles and stabilize mechanical performance.
We provide:
Controlled post-curing ovens (150–200°C)
Part trimming and de-flashing
Plasma surface treatment if bonding is required
Printing, packaging, and cleanroom-compatible processing
We regularly supply molds and silicone parts used in:
Respiratory and ventilation devices
Drug-delivery systems (valves, check valves, pump membranes)
Wearable medical electronics (gaskets, soft interfaces, seals)
Diagnostics equipment
Infant care products
Rapid-response seals and micro-fluidic components
Technical Specifications
Material Options
Medical-grade Liquid Silicone Rubber (LSR)
Self-lubricating silicone
High-transparency optical silicone
High-resilience elastomers for valves and diaphragms
Mold Construction
Cold runner / valve gate LSR molds
Hardened stainless steel or corrosion-resistant steel
Thermal isolation between hot cavities and cold deck
Mirror-polish cavities for optical clarity
2K LSR-over-plastic molding (PC, PA, PEEK, PPSU)
Supported Part Geometry
Wall thickness from 0.3 mm
Micro-fluidic channels
Thin-walled medical seals
Under-cut structures
Multi-cavity and fully automated high-volume molds
Process Capabilities
Fully automated LSR injection molding
Robot handling and in-mold demolding
Precision mold temperature control
Short cycle times for high-volume programs
Controlled post-curing process
Advantages of Our Medical LSR Molds
Stable and repeatable molding processes for regulated industries
Low-flash cavity design suitable for Class I & II medical devices
Capability to handle high-volume programs with consistent tool life
Cleanroom-compatible production support
Engineering assistance throughout device development
Typical Medical LSR Molded Parts
Precision seals and diaphragms
Drug-delivery valves
Syringe and pump components
Infant care silicone pieces
Soft-touch grips for surgical tools
LSR caps, grommets, membranes, micro-components
Your Partner for Medical Silicone Manufacturing
Whether your project requires a new LSR mold, high-precision liquid injection molding, or a complete medical silicone manufacturing solution, our team provides engineering support from DFM to mass production.
Contact Us for a Free Technical Review
If you have drawings or are considering switching to LSR molded parts, our engineers can evaluate your design and recommend the most efficient molding process.
Medical LSR Mold – Professional FAQ
Q: What makes a Medical LSR mold different from a standard LSR mold?
A: Medical LSR molds must meet higher requirements for precision, flash control, biocompatibility, and surface finish. They are typically built with:
Medical-grade stainless steel or corrosion-resistant tool steel
Ultra-tight tolerances (often ±0.01–0.02 mm)
Vacuum-assisted cavity design
Polished surfaces suitable for optical-clear or implant-safe parts
These molds are optimized for producing components used in patient-contact or implantable applications.
Q: Which medical products are commonly produced with LSR molds?
A: Medical LSR molds are widely used for:
Sealing components for ventilators and oxygen delivery systems
Syringe stoppers and plunger tips
Catheter tips and respiratory masks
Medical-grade valves and diaphragms
Wearable patch components and sensor housings
Infant care products (nipples, pacifier components)
Implantable components (depending on material certification)
Q: Are Medical LSR molds compatible with Class VI or ISO 10993 certified silicone materials?
A: Yes. Medical LSR molds are specifically designed for ISO 10993, USP Class VI, and other fully biocompatible LSR materials. The mold surface finish and parting-line control ensure the material's performance is not compromised during processing.
Q: How do you ensure zero-flash or ultra-low flash performance in medical LSR molding?
A: We apply multiple design and process strategies:
Metal-to-metal shutoff precision within 0.005–0.01 mm
Optimized venting channels for LSR flow characteristics
Balanced cold runner feeding with valve-gate nozzles
Mold vacuum system to stabilize volumetric fill
Temperature control within ±1°C across all cavities
These methods ensure clean sealing edges and virtually no secondary trimming.
Q: Can the mold support micro-LSR parts or very small features?
A: Yes. Our medical LSR molds support:
Micro-channel geometries
Thin walls down to 0.2–0.3 mm
Optical-grade surfaces
Complex undercuts using micro-slides or micro-core pins
This is critical for microfluidic, diagnostic, and wearable devices.
Q: What is the typical mold life for Medical LSR molds?
A: Mold life depends on steel and cavity design, but typical ranges are:
500,000 – 1,000,000 shots for standard FDA-grade devices
Up to 2,000,000 shots for high-grade stainless steel molds
Proper maintenance can extend life significantly due to LSR's low viscosity and non-abrasive characteristics.
Q: Do you provide multi-cavity Medical LSR molds?
A: Yes. Depending on part size and tolerance requirements, we manufacture:
2-cavity to 32-cavity molds for mass production
Fully balanced cold runners (with thermal insulation)
Valve-gate systems for perfect part-to-part consistency
Multi-cavity design reduces per-part cost while maintaining medical accuracy.
Q: Are overmolding or 2K LSR + plastic parts possible?
A: Absolutely. We provide:
LSR overmolding onto PC, PBT, PP, PA, PEI, and other engineering plastics
2K rotary table systems or transfer pick-and-place systems
Medical bonding-grade LSR formulations
This is widely used for catheters, seals, handles, and diagnostic components.
Q: What documentation can you provide for medical projects?
A: We support a full medical manufacturing documentation package:
Material certificates and traceability documents
Mold steel certificates
First Article Inspection (FAI) / PPAP
Process validation (IQ, OQ, PQ)
Inspection reports and dimensional data
Full DFM, mold-flow analysis, and design review
These documents match regulatory expectations for EU and US markets.
Q: What are the lead times for building a Medical LSR mold?
A: Typical development times:
DFM + Moldflow: 3–5 days
Mold fabrication: 4–7 weeks depending on complexity
Sampling & optimization: 1–2 weeks
Total: 5–8 weeks, with expedited options available for urgent medical programs.
Q: What manufacturing standards do you follow for medical molds?
A: We follow:
ISO 13485 manufacturing system
Class 8 or Class 7 cleanroom molding capability (upon request)
FDA, USP Class VI, and ISO 10993 material compliance
EU MDR requirements
This ensures safety, consistency, and regulatory readiness.
Q: How do you guarantee optical clarity for transparent medical LSR parts?
A: We use:
Diamond-polished cavity surfaces (SPI A1-A2)
Temperature-stable cavity inserts
Degassing and vacuum control
Laminar flow considerations during part filling
This is essential for components used in visualization, sensors, and flexible optics.
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