Medical-Grade Liquid Silicone Rubber (LSR)
Medical-grade LSR liquid silicone compounds for injection molding in an ISO 8 cleanroom. Compliance with USP VI, ISO 10993, FDA 21 CFR 177.2600, and EC 1935/2004. Biocompatibility, purity, and total traceability for medical, pharmaceutical, and laboratory applications.
Material Principle
Medical LSR liquid silicone is a two-component, platinum-cured elastomer formulated specifically for high-purity environments. It enables the fully automated injection molding of medical, pharmaceutical, and in-vitro diagnostic components with micrometric tolerances.
Formulation and Certifications
Compliant with regulations USP Class VI, ISO 10993, FDA 21 CFR 177.2600, and EC 1935/2004. Free of byproducts, plasticizers, and heavy metals. Sterilizable by autoclave, steam, or gamma radiation. Each batch is supplied with traceability and a certificate of conformity.
Technical Properties
Available in hardnesses from 20 to 90 Shore A. High transparency, thermal stability from -60 °C to +230 °C, and excellent chemical resistance. Physiologically inert, non-cytotoxic material suitable for prolonged contact with tissues and bodily fluids.
Production Environments
Production in a validated ISO 8 cleanroom under ISO 9001 and ISO 13485 quality systems. Auditable, controlled, and traceable processes, with biocompatibility, accelerated aging, and dimensional validation tests.
Product Gallery
Key Technical Data
Typical values obtained according to series datasheets (17, 30) and indicated standards. May vary based on hardness, formulation, and application. Final validation is the customer's responsibility.
| Property | Typical Values | Standard |
|---|---|---|
| Hardness (Shore A) | 20 – 70 (núcleo habitual: 40–60) | ISO 7619-1 |
| Tensile Strength | 7 – 11 MPa | ISO 37 |
| Elongation at Break | 400 – 1200 % | ISO 37 |
| Tear Resistance (Type C) | 17 – 47 kN/m | ISO 34-1 |
| Density | 1,11 – 1,20 g/cm³ | ISO 2781 |
| Working Temperature | –60…+200 °C (up to +215 °C in some formulations) | — |
| Tolerances | Molding Class M2 (LSR Injection) | ISO 3302-1 |
| Sectoral (On Request) | FDA / CE 1935/2004 / USP VI / ISO 10993 / RoHS / REACH | — |
Certifications and Regulatory Compliance in Silicone Molding
Every molding batch is manufactured under strict validation protocols, guaranteeing conformity with international standards and integral traceability of the material and the mold.
Main Certifications
- ISO 9001:2015 – Quality Management System
- ISO 13485:2016 – Medical Devices
- EN 9100 – Aerospace and Defense
- GMP – Good Manufacturing Practices
- ISO 10993 – Medical Biocompatibility
- USP Class VI – Pharmaceutical Biocompatibility
Regulatory Compliance
- FDA 21 CFR 177.2600 – Food Contact
- EC 1935/2004 – Materials in Contact with Food
- EN 45545-2 – Railway Fire Protection
- UL94 – Material Flammability
- ISO 10993 and USP Class VI – Medical and Pharmaceutical Biocompatibility
- REACH (1907/2006) and RoHS (2015/863) – Chemical and Electrical Substances
Main Application Sectors
Key Applications
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Medical gaskets, membranes, and valves
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Implantable components and catheters
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Dosing systems and peristaltic pumps
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Buttons, stoppers, and parts for sanitary devices
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Optical encapsulation and biomedical sensors
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Precision components for automatic dosing syringes
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Membranes for mechanical ventilator pressure regulators
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Contact tips and seals for laparoscopy instruments
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Microfluidic control valves in blood analysis equipment
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Seals for ultrasound diagnostic equipment
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Ergonomic grip parts and handles for surgical instruments
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Airway and anaesthetic mask components
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Gaskets for high-speed laboratory centrifuge lids
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Hermetic stoppers for sterile sample containers
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Safety membranes and valves for intravenous infusion kits
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Lenses and light guides for endoscopes (Optical LSR)
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Connectors for extracorporeal circulation pump tubing
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Parts for negative pressure wound therapy (NPWT) devices
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Seals for steam and ethylene oxide sterilisation equipment
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Plugs for access holes in MRI equipment
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Components for patient monitoring systems (wearables)
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Diaphragms for air pumps in pressure-relief mattress devices
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Miniature gaskets for cochlear implant devices
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Valves and membranes for inhaled drug delivery
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Components for nerve stimulation device housing
Manufacturing and Delivery Options
- Hardness: 10 to 80 Shore A
- Colors: Translucent, pigmented, or optical grade
- Formulation: 100% platinum cure, byproduct-free
- Certifications: USP VI, ISO 10993, FDA, EC 1935/2004
- Production: Certified ISO 8 Cleanroom
- Delivery: Sterilizable, traced, and certified parts
Recommended Related Products
Product Selection Matrix
| Customer Requirement | Recommended Solution |
|---|---|
| Food-contact components | Food-Grade LSR |
| High-precision technical parts | HCR Injection Molding |
| Medical and optical microcomponents | LSR Injection Molding |
| Integration with inserts or multi-component systems | Overmolding |
Technical Conclusion and Recommendations
Medical LSR liquid silicone from ProSilicones64 represents the highest standard in biocompatibility, precision, and purity for the healthcare sector.
Manufactured in an ISO 8 cleanroom under ISO 9001 and ISO 13485 control, and certified according to USP VI, ISO 10993, and FDA, it ensures safety and total traceability in critical applications.
A solution designed for new-generation medical devices that demand absolute performance, cleanliness, and stability.
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