Medical and Pharmaceutical Silicone Tubing
Biocompatible silicone tubing manufactured in ISO 8 cleanroom under ISO 13485 quality management. Platinum-cured formulations certified to USP Class VI and ISO 10993 for medical devices, diagnostic equipment and pharmaceutical processes.
A silicone tube for medical or pharmaceutical use is not simply a "clean" tube. Biocompatibility must be demonstrated to USP Class VI or ISO 10993 depending on the nature and duration of contact with the patient or the pharmaceutical product. The manufacturing environment must be validated to prevent particulate contamination that compromises the safety of the finished device. And full batch traceability is a regulatory requirement, not an option.
We manufacture medical and pharmaceutical tubing in an ISO 8 cleanroom (550 m2 validated to ISO 14644) under an ISO 13485 quality management system. The reference formulation is Series 12, a platinum-cured VMQ silicone that generates no cure by-products and holds USP Class VI, ISO 10993 and FDA certifications. For applications requiring short-term implantable biocompatibility (< 29 days), Series 17 with NUSIL grade delivers exceptional mechanical properties (up to 1,200 % elongation, 46.7 kN/m tear strength) with an option for radiopaque additive. For peristaltic pumps integrated into medical devices, Series 30 combines biocompatibility with cyclic-fatigue resistance.
Tubing manufactured with the EQ1260T formulation from Series 12 is validated for integration into CE-marked medical devices. Inside diameters from 0.5 mm to 50 mm, with wall thicknesses from 0.25 to 10 mm. Every batch is delivered with a certificate of conformity, full raw-material traceability and supporting documentation for the device manufacturer's technical file.
Medical-grade tubing or implantable-grade tubing?
Not all "medical" tubing is implantable. Series 12 covers the majority of applications: aspiration tubing, external drainage, diagnostic equipment circuits, pharmaceutical process connections. Series 17 (NUSIL grade) is required when the tube comes into direct contact with tissue or body fluid for a period of less than 29 days. The device classification and biological evaluation to ISO 10993-1 determine which formulation you need.
Which medical tube do you need?
Locate your primary requirement and the recommended formulation. The device classification and biological evaluation to ISO 10993-1 determine the testing required.
| Requisito | Formulación | Serie | Proceso |
|---|---|---|---|
| External medical device (Class I, IIa) | VMQ Platinum | Serie 12 | Extrusion + Cleanroom |
| CE marking with validated formulation | VMQ Platinum EQ1260T | Serie 12 | Extrusion + Cleanroom |
| Short-term implantable (< 29 days) | VMQ Platinum NUSIL | Serie 17 | Extrusion + Cleanroom |
| Radiopaque tubing for localisation | VMQ Platinum + additive | Serie 17 | Extrusion + Cleanroom |
| Peristaltic pump in medical device | VMQ Cyclic fatigue | Serie 30 | Extrusion + Cleanroom |
| Pharmaceutical / biotech processing | VMQ Platinum | Serie 12 | Extrusion + Cleanroom |
| In-vitro diagnostics (IVD) | VMQ Platinum | Serie 12 | Extrusion + Cleanroom |
| Visual line identification | VMQ Platinum + stripe | Serie 12 | Co-extrusion + Cleanroom |
| Ultra-thin wall / high flexibility | VMQ Platinum NUSIL | Serie 17 | Extrusion + Cleanroom |
Medical tube types by application
Single-layer tubing for medical devices
Single-layer silicone tube with homogeneous wall, manufactured in ISO 8 cleanroom. Series 12 formulation with platinum cure. Transparent or translucent for visual fluid inspection. Smooth internal bore to minimise bacterial adhesion and facilitate cleaning. This is the standard configuration for the majority of Class I and Class IIa medical devices.
Tubing with identification stripe (lisere)
Single-layer tube with an integral coloured line co-extruded into the wall. The line is not a printed mark but coloured silicone co-extruded with the tube, ensuring it does not degrade or contaminate the fluid. Enables line identification in devices with multiple circuits without additional labelling.
Short-term implantable tubing (Series 17)
NUSIL-grade formulation validated for contact with tissue or body fluid for periods of less than 29 days. Exceptional mechanical properties: up to 1,200 % elongation and 46.7 kN/m tear strength. Option for radiopaque additive for localisation by fluoroscopy. Manufactured in ISO 8 cleanroom.
Medical peristaltic pump tubing
Series 30 formulation with platinum cure, designed to withstand the repeated cyclic deformation of peristaltic pumps integrated into medical devices. Combines biocompatibility (FDA, USP VI, ISO 10993) with high fatigue resistance. Hardness range 50 to 65 Shore A.
Dimensional ranges by medical application
Medical tubing requires tighter dimensional tolerances than industrial tubing: inside diameter determines flow rate in infusion pumps, wall thickness governs resistance to vacuum collapse, and concentricity affects coupling with Luer or barbed connectors. Tooling held in stock for the most common medical device dimensions.
Micro-bore tubing for diagnostics and analysis
ID 0.5 to 3 mmMinimum-bore tubing for internal circuits of in-vitro diagnostic equipment, blood analysers and micro-pump connections. Bore uniformity is critical for repeatability of dispensed volumes. Minimum wall thickness 0.25 mm.
- Inside diameter
- 0.5 to 3 mm
- Wall thickness
- 0.25 to 1.5 mm
- ID tolerance
- ±0.1 mm typical
Formulations: Series 12 (medical standard), Series 30 (peristaltic), Series 17 (implantable).
Standard medical device tubing
ID 3 to 12 mmPrincipal range for the majority of medical devices: aspiration, drainage, infusion, equipment connections. Compatible with Luer connectors, barbed fittings and standard couplings. Includes the most demanded dimensions for diagnostic equipment, clinical laboratory and surgery.
- Inside diameter
- 3 to 12 mm
- Wall thickness
- 0.5 to 3 mm
- Typical supply form
- Coils of 25 or 50 m
Formulations: Series 12 (standard), Series 17 (implantable), with identification stripe.
Pharmaceutical equipment and process tubing
ID 12 to 25 mmIntermediate bore sizes for pharmaceutical product transfer, bioreactor connections, aseptic processing circuits and filling lines. Compatible with tri-clamp and sanitary fittings.
- Inside diameter
- 12 to 25 mm
- Wall thickness
- 2 to 5 mm
- Typical supply form
- Coils of 10 or 25 m
Formulations: Series 12 (platinum), Series 30 (peristaltic), textile-reinforced (pressurised).
Large-bore tubing for special equipment
ID 25 to 50 mmLarge-diameter tubing for flexible ducting on large-format equipment, connection sleeves and ventilation circuits in medical environments. Manufactured to drawing with dedicated tooling if the dimension is not available from stock.
- Inside diameter
- 25 to 50 mm
- Wall thickness
- 3 to 7 mm
- Typical supply form
- Cut to length
Formulations: Series 12 (platinum), textile-reinforced (pressure/vacuum).
For CE-marked medical devices, tubing with the EQ1260T formulation (Series 12, 60 Shore A) is validated. For other hardnesses or formulations, consult available documentation for the technical file. Tolerances: ISO 3302-1 class E1.
Which formulation does your medical tube need?
VMQ Platinum — medical devices (Series 12)
The reference formulation for the majority of medical devices. Platinum-cured with no by-products, biocompatible to USP Class VI and ISO 10993, manufactured in ISO 8 cleanroom. Full hardness range from 20 to 90 Shore A. No post-cure required.
Class I and IIa medical devices, diagnostic equipment, clinical laboratory, pharmaceutical processing, CE marking with EQ1260T formulation.
| Property | EQ1220 | EQ1240 | EQ1250 | EQ1260 | EQ1270 |
|---|---|---|---|---|---|
| Hardness (±5 Shore A) | 20 | 40 | 50 | 60 | 70 |
| Tensile strength (MPa min) | 6 | 7 | 8 | 9 | 8.5 |
| Elongation (% min) | 1000 | 700 | 750 | 650 | 550 |
| Tear strength (kN/m min) | 17 | 20 | 30 | 30 | 30 |
| Density (g/cm3) | 1.11 | 1.12 | 1.14 | 1.17 | 1.18 |
Temperature: –60 to +200 °C (extendable to +300 °C / +315 °C with HT additive). Certifications: USP Class VI, ISO 10993, FDA, CE 1935/2004, BfR. The EQ1260T formulation is validated for CE-marked medical devices.
VMQ Platinum implantable — NUSIL grade (Series 17)
Short-term implantable silicone (< 29 days) with NUSIL data. Exceptional mechanical properties enabling thinner tube walls without compromising strength. Option for radiopaque additive for localisation by fluoroscopy or radiography.
Temporary surgical drains, catheters, nasogastric probes, chest drainage tubes, any tubing in contact with tissue or body fluid for up to 29 days.
| Property | EQ1725 | EQ1735 | EQ1765 | EQ1780 |
|---|---|---|---|---|
| Hardness (±5 Shore A) | 25 | 35 | 65 | 80 |
| Tensile strength (MPa min) | 9.7 | 10.8 | 8.6 | 7.9 |
| Elongation (% min) | 1200 | 1000 | 1000 | 700 |
| Tear strength (kN/m min) | 33.5 | 34 | 46.7 | 39 |
| Density (g/cm3) | 1.11 | 1.11 | 1.20 | 1.20 |
Temperature: –60 to +200 °C. Certifications: USP Class VI, ISO 10993 (applicable parts depend on formulation). Base colour translucent. The 1,200 % elongation and 46.7 kN/m tear strength are exceptional — enabling thin-wall designs with high reliability. Radiopaque additive option available.
VMQ Platinum cyclic fatigue — medical peristaltic (Series 30)
Specific formulation for peristaltic pumps integrated into medical devices. High cyclic-deformation resistance with full biocompatibility. Combines the certification required for the device with the service life demanded by continuous peristaltic operation.
Peristaltic pumps in analysers, dialysis equipment, diagnostic reagent dispensers, pharmaceutical bioreactors.
| Property | EQ3050 | EQ3060 | EQ3065 |
|---|---|---|---|
| Hardness (±5 Shore A) | 50 | 60 | 65 |
| Tensile strength (MPa min) | 8 | 8.5 | 8.8 |
| Elongation (% min) | 500 | 400 | 400 |
| Tear strength type C (kN/m min) | 27 | 17 | 39 |
| Density (g/cm3) | 1.14 | 1.14 | 1.17 |
Temperature: –60 to +180 °C (extendable to +215 °C with additive, requires pigmentation). Certifications: FDA, USP Class VI, ISO 10993. Extrusion only (EQ). Tear strength of 39 kN/m at 65 Shore A — exceptional for high-duty pumps.
The reference formulation for the majority of medical devices. Platinum-cured with no by-products, biocompatible to USP Class VI and ISO 10993, manufactured in ISO 8 cleanroom. Full hardness range from 20 to 90 Shore A. No post-cure required.
Class I and IIa medical devices, diagnostic equipment, clinical laboratory, pharmaceutical processing, CE marking with EQ1260T formulation.
| Property | EQ1220 | EQ1240 | EQ1250 | EQ1260 | EQ1270 |
|---|---|---|---|---|---|
| Hardness (±5 Shore A) | 20 | 40 | 50 | 60 | 70 |
| Tensile strength (MPa min) | 6 | 7 | 8 | 9 | 8.5 |
| Elongation (% min) | 1000 | 700 | 750 | 650 | 550 |
| Tear strength (kN/m min) | 17 | 20 | 30 | 30 | 30 |
| Density (g/cm3) | 1.11 | 1.12 | 1.14 | 1.17 | 1.18 |
Temperature: –60 to +200 °C (extendable to +300 °C / +315 °C with HT additive). Certifications: USP Class VI, ISO 10993, FDA, CE 1935/2004, BfR. The EQ1260T formulation is validated for CE-marked medical devices.
Short-term implantable silicone (< 29 days) with NUSIL data. Exceptional mechanical properties enabling thinner tube walls without compromising strength. Option for radiopaque additive for localisation by fluoroscopy or radiography.
Temporary surgical drains, catheters, nasogastric probes, chest drainage tubes, any tubing in contact with tissue or body fluid for up to 29 days.
| Property | EQ1725 | EQ1735 | EQ1765 | EQ1780 |
|---|---|---|---|---|
| Hardness (±5 Shore A) | 25 | 35 | 65 | 80 |
| Tensile strength (MPa min) | 9.7 | 10.8 | 8.6 | 7.9 |
| Elongation (% min) | 1200 | 1000 | 1000 | 700 |
| Tear strength (kN/m min) | 33.5 | 34 | 46.7 | 39 |
| Density (g/cm3) | 1.11 | 1.11 | 1.20 | 1.20 |
Temperature: –60 to +200 °C. Certifications: USP Class VI, ISO 10993 (applicable parts depend on formulation). Base colour translucent. The 1,200 % elongation and 46.7 kN/m tear strength are exceptional — enabling thin-wall designs with high reliability. Radiopaque additive option available.
Specific formulation for peristaltic pumps integrated into medical devices. High cyclic-deformation resistance with full biocompatibility. Combines the certification required for the device with the service life demanded by continuous peristaltic operation.
Peristaltic pumps in analysers, dialysis equipment, diagnostic reagent dispensers, pharmaceutical bioreactors.
| Property | EQ3050 | EQ3060 | EQ3065 |
|---|---|---|---|
| Hardness (±5 Shore A) | 50 | 60 | 65 |
| Tensile strength (MPa min) | 8 | 8.5 | 8.8 |
| Elongation (% min) | 500 | 400 | 400 |
| Tear strength type C (kN/m min) | 27 | 17 | 39 |
| Density (g/cm3) | 1.14 | 1.14 | 1.17 |
Temperature: –60 to +180 °C (extendable to +215 °C with additive, requires pigmentation). Certifications: FDA, USP Class VI, ISO 10993. Extrusion only (EQ). Tear strength of 39 kN/m at 65 Shore A — exceptional for high-duty pumps.
From compound to validated medical tube
Medical tubing is manufactured entirely within an ISO 8 cleanroom validated to ISO 14644, under an ISO 13485 quality management system. Every stage of the process is documented to facilitate integration into the device manufacturer's technical file.
Application sectors
Medical
Biocompatible tubing for medical devices, diagnostic equipment and surgery.
Pharmaceutical
Tubing for pharmaceutical processing, biotech, bioreactors and aseptic filling.
Food & Beverage
FDA and CE 1935/2004 certified tubing for food process lines with biocompatibility requirements.
Industrial
Medical-grade tubing for industrial applications with purity or cleanroom requirements.
Related products
Peristaltic tubing
Tubing optimised for peristaltic pumps with high cyclic-fatigue resistance.
Food-grade tubing
FDA and CE 1935/2004 certified platinum-cured tubing for food contact.
Custom profiles
Biocompatible extruded profiles for medical devices and pharmaceutical equipment.
Silicone moulded parts
LSR injection-moulded parts in cleanroom for medical device components.
Need silicone tubing for your medical device?
Tell us the device classification, required dimensions, nature and duration of patient contact and the certifications needed. Our technical team will confirm the appropriate formulation and available documentation for your technical file.
Request quotation