ISO 13485 & WHO-GMP certified platinum-cured silicone tubing engineered in cleanroom facilities. Trusted by global medical device manufacturers and healthcare importers in 90+ countries.
High-purity platinum-cured formulations with zero peroxide residues. Superior tear strength, non-hemolytic properties, and strict dimensional tolerances for peristaltic pump applications.
In modern biopharmaceutical fluid transfer, surgical drainage, peristaltic dosing, and invasive critical care devices, Medical Silicone Tubing serves as an unyielding line of defense between life-saving therapy and biological contamination. Procurement directors, medical device OEM designers, and regulatory affairs managers face stringent scrutiny regarding extractables and leachables (E&L), particulate contamination, wall concentricity, and long-term biocompatibility under European Medical Device Regulation (EU MDR 2017/745) and US FDA 21 CFR guidelines.
Sterimed Group, through its dedicated high-purity silicone division Ultrasil, leverages over six decades of polymer engineering expertise to manufacture precision medical silicone tubing. Operating out of ISO Class 7 and Class 8 cleanrooms, our facilities utilize state-of-the-art continuous vulcanization extrusion systems powered by 100% platinum-cured liquid silicone rubber (LSR) and high-consistency rubber (HCR). By eliminating organic peroxide catalyst residues, our extrusions eliminate risks of cytotoxic leaching, discoloration, or chemical alteration of sensitive pharmaceutical fluids and human tissue.
Selecting the correct cure system, durometer hardness, and reinforcement profile is critical for medical device integration. Review our standard technical engineering parameters below.
| Property / Parameter | Ultrasil Pureline (Platinum Cured) | Ultrasil Polybraid (Reinforced) | Ultrasil Oxide (Radio-Opaque) | Peroxide-Cured Standard Grade |
|---|---|---|---|---|
| Cure Mechanism | Platinum Addition Cure | Platinum / Polyester Braid | Platinum Addition Cure | Peroxide Catalyst |
| Hardness (Shore A) | 30 Shore A to 80 Shore A | 60 Shore A to 70 Shore A | 50 Shore A to 70 Shore A | 50 Shore A to 70 Shore A |
| Tensile Strength (MPa) | ≥ 10.5 MPa | ≥ 12.0 MPa (Burst resistant) | ≥ 9.8 MPa | ≈ 8.5 MPa |
| Elongation at Break (%) | 450% - 750% | 350% - 500% | 400% - 600% | 350% - 500% |
| Extractables & Leachables | Ultra-Low (< 0.01% Volatiles) | Ultra-Low (< 0.01% Volatiles) | Ultra-Low / Inert BaSO4 | Trace Organic Acid Residues |
| Sterilization Compatibility | Autoclave, EO Gas, Gamma (50kGy) | Autoclave, EO Gas | Autoclave, EO Gas, Gamma | Autoclave, EO Gas |
| Primary Application | Parenteral, Peristaltic Pumps, ICU | High-Pressure Fluid Transfer | Invasive Surgical Drainage & Catheters | Non-Critical General Fluid Lines |
Explore Sterimed’s specialized Ultrasil range developed for diagnostic, pharmaceutical, surgical, and critical care applications.
100% platinum-cured high-purity silicone tubing. Features mirror-smooth inner bore to eliminate protein binding and fluid stagnation during critical biopharmaceutical filtration and IV administration.
Polyester braid reinforced platinum silicone hose designed for high-pressure fluid lines, peristaltic filling pumps, and bioprocess vessel transfer where kink-resistance and burst strength are mandatory.
Co-extruded with Barium Sulfate (BaSO4) radio-opaque striping or full-line opacity. Essential for fluoroscopic visibility in surgical drains, tracheostomy tubes, and cardiac bypass circuits.
Specifically engineered for extended dynamic fatigue life in peristaltic dosing pumps. Delivers consistent flow calibration without spallation or wall deformation over prolonged cycle runs.
Custom engineered multi-lumen silicone tubing, ribbon cables, and hollow geometries for advanced diagnostic equipment, urinary catheters, and endoscopic fluid management.
Liquid Silicone Rubber (LSR) liquid-injection molded seals, tri-clamp gaskets, septa, and custom connectors designed to integrate seamlessly with medical-grade silicone tubing assemblies.
Insights for supply chain directors navigating regulatory updates, micro-extrusion demands, and sustainable supply chains from 2025 to 2035.
Global regulatory bodies, led by the European Medicines Agency (EMA) and US FDA, are accelerating restrictions on residual solvents and volatile organic compounds (VOCs). Peroxide-cured silicone is rapidly being phased out across Western markets due to potential leachables like benzoic acid and 2,4-dichlorobenzoic acid. Global procurement strategies now mandate platinum-cured silicone tubing as standard for all invasive and contact medical applications to guarantee regulatory approval under EU MDR Annex I requirements.
The rapid growth of minimally invasive surgical (MIS) procedures, neurovascular therapies, and micro-fluidic diagnostic tools requires ultra-small lumen silicone extrusions. Future procurement cycles heavily favor suppliers capable of achieving inner diameters smaller than 0.2 mm with outer diameter tolerances within ±0.01 mm. Multi-lumen silicone tubing—enabling simultaneous medication delivery, inflation, and suction within a single narrow shaft—is witnessing an unprecedented surge in B2B demand.
Recent global logistics disruptions and geopolitical realignments have driven multinational medical device OEMs to restructure their raw material and OEM component sourcing. Global purchasing managers are actively establishing direct partnerships with fully integrated Indian manufacturing conglomerates like Sterimed Group. Offering ISO 13485 cleanroom infrastructure, competitive cost structures, WHO-GMP alignment, and English-speaking technical support, India has emerged as the premier global hub for medical-grade silicone extrusions.
Next-generation medical silicone tubing is evolving beyond passive fluid conduits. Active research and procurement requests increasingly focus on surface-modified silicone extrusions featuring silver nanoparticle impregnated coatings, hydrophilic lubricious treatments to minimize trauma during insertion, and specialized biocide surface entrapment to prevent catheter-associated urinary tract infections (CAUTI) and ventilator-associated pneumonia (VAP).
When negotiating bulk silicone tubing supply contracts, ensure your vendor provides a complete Master Validation File including post-bake protocol parameters, continuous laser concentricity logs, and batch-specific Extractables & Leachables (E&L) certificates. Sterimed provides turnkey regulatory support packages with every shipment.
Built on seven decades of quality manufacturing, robust infrastructure, and absolute regulatory transparency.
In-house precision tool design, custom extrusion die manufacturing, and automated curing lines give Sterimed full control over turnaround times, prototype iterations, and scale production.
Extruded in certified cleanroom environments operating under ISO 9001 and ISO 13485 quality systems. Every batch is subjected to strict particulate, microbial, and dimension validation.
From custom branding, private label packaging, and cut-to-length tubing to full CE documentation and Free Sale Certificates (FSC), our export desk supports buyers across 90+ nations.
Discover our specialized ultra-pure medical tubing and molded components. High-purity silicone engineered for biopharmaceutical, ICU, peristaltic pump, and surgical fluid transfer lines.
Founded in 1955, Sterimed Group brings together Sterimed Medical Devices, Sterimed Surgicals, Ultrasil, and Ablestick to deliver comprehensive healthcare disposable solutions worldwide.
Technical clarity for medical device developers, procurement heads, and quality assurance inspectors.
Platinum-cured silicone tubing utilizes an addition-cure polymerization mechanism that produces zero chemical cross-linking residues or peroxide by-products. This results in maximum optical clarity, exceptional tear strength, superior biocompatibility, and ultra-low extractables. In contrast, peroxide-cured silicone relies on free-radical crosslinking, leaving organic acid residues that can yellow over time, leach into sensitive pharmaceutical fluids, or irritate biological tissue.
For critical medical device applications, drug delivery systems, and invasive catheters, platinum-cured silicone tubing is the mandatory industry benchmark recommended by global health authorities.
Sterimed Ultrasil medical silicone tubing is manufactured under ISO 13485 and ISO 9001 quality management systems compliant with WHO-GMP guidelines. Raw material formulations meet United States Pharmacopeia (USP) Class VI requirements, ISO 10993 biological evaluation criteria (including Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, and Hemocompatibility), European Pharmacopoeia (EP 3.1.9), REACH, and RoHS standards. Certificates of Analysis (CoA) and full batch traceability documentation are provided with all commercial shipments.
Sterimed offers comprehensive OEM and private label manufacturing for international distributors and medical device makers. Our capabilities include:
• Custom inner diameters (ID from 0.2 mm to 50 mm) and wall thicknesses.
• Durometer hardness tuning from soft 30 Shore A to rigid 80 Shore A.
• Radio-opaque barium sulfate (BaSO4) stripe co-extrusion for X-ray visibility.
• Custom color tinting, multi-lumen profiles, and reinforced braided tubing.
• Cut-to-length tubing, specialized end-forming, and individual pouch sterile packing.
Ultrasil Clave and Flexo tubing grades are specifically engineered for high dynamic resilience and long-term flexing in peristaltic pumps. Formulated with high-tear-strength platinum-cured silicone elastomer, our peristaltic tubing resists wall collapse, maintains calibrated volumetric displacement accuracy, and minimizes spallation (shedding of micro-particles) during extended pumping cycles in dialysis machines, IV infusion pumps, and pharmaceutical filling lines.
Silicone elastomer maintains structural integrity over extreme temperature ranges (-60°C to +230°C). Sterimed medical silicone tubing can be repeatedly sterilized using:
1. Steam Autoclaving: Standard 121°C at 15 psi for 30 minutes or 134°C high-speed cycles.
2. Ethylene Oxide (EO) Gas: Standard validated cycles with appropriate degassing periods.
3. Gamma Radiation & E-Beam: Dosages up to 50 kGy without embrittlement or severe color shift.
Extruded silicone tubing undergoes a controlled post-curing process in forced-air circulating ovens at elevated temperatures (up to 200°C for multiple hours). This step completely volatilizes residual low-molecular-weight siloxanes and cyclics. Extractables & Leachables (E&L) profiling reports conducted in accordance with USP <661> and ISO 10993-18 are available upon request to facilitate buyer regulatory filings.
Minimum Order Quantities (MOQs) depend on the tube geometry, custom color/striping requirements, and packaging formats. Standard catalog sizes carry minimal MOQs, while custom OEM extrusions typically require a baseline run length. Standard delivery lead times range from 2 to 4 weeks upon order confirmation. Contact our export team at [email protected] for tailored quotation details.
Partner directly with India's trusted medical disposables manufacturer. Contact our export desk today for pricing, technical datasheets, and sample packs.
Email: [email protected] | Tel: +91-11-48880000