Unlike peroxide-cured alternatives, our platinum cured medical grade Class VI USP silicone tubing offers very low extractables, minimal leachables risk, and exceptional clarity.
It maintains flexibility without kinking, performs reliably under pressure or vacuum, and withstands repeated sterilization cycles by autoclave, gamma irradiation, or ethylene oxide (EtO).
For procurement managers: Reduced maintenance costs, lower total cost of ownership (TCO), and audit-ready compliance documentation included with every shipment.
What Are Platinum Cured Silicone Profiles?
When specifying tubing for sensitive applications, not all silicone is the same. Platinum cured profiles offer the highest assurance of safety, purity, and regulatory compliance — factors that streamline both engineering designs and purchasing decisions.
Key Certifications Included with Every Order
| Certification | Relevance |
|---|---|
| USP Class VI | Passes cytotoxicity, systemic toxicity, and implantation tests. Safe for direct contact with human tissues or fluids. |
| FDA 21 CFR 177.2600 | Compliant for medical devices and food contact applications. Non-toxic, non-reactive, no harmful leachables. |
| NSF/ANSI 51 | Certified for food equipment. Ensures non-toxicity, non-leaching, and physical integrity. |
| ISO 10993 (upon request) | Biocompatibility for medical device regulatory submissions. |
Platinum-Cured vs. Peroxide-Cured: Why It Matters
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Platinum-cured (addition-cure): Uses a platinum catalyst. Leaves no residual byproducts like benzene derivatives or acidic compounds. Produces ultra-pure, transparent tubing.
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Peroxide-cured: Can leave acidic residues that interfere with sensitive biological or pharmaceutical processes.
For biomedical engineers looking to reduce risk in patient-contact applications, platinum cured silicone tubing is the only acceptable choice.
Technical Specifications & Manufacturing Tolerances
Our extrusion process delivers tight dimensional control, ensuring repeatable performance for peristaltic pumps, drug delivery systems, and dialysis equipment.
Dimensional Tolerances
| Parameter | Standard Tolerance | Custom Capability |
|---|---|---|
| Inner Diameter (ID) | ±0.13 mm or better | Tighter upon request |
| Outer Diameter (OD) | ±0.13 mm or better | Tighter upon request |
| Wall thickness consistency | High uniformity | Application-specific |
| Length per piece | Custom (1 m to 500+ m coils) | Cut-to-length available |
Physical Properties & Performance
| Property | Value / Range | Test Method |
|---|---|---|
| Shore A hardness | 30 – 80 (customizable) | ASTM D2240 |
| Temperature range | -60°C to 200°C | — |
| Burst pressure ratings | Application-dependent | Calculated per ID/OD/wall |
| Tensile strength | 6 – 10 MPa (varies by durometer) | ASTM D412 |
| Elongation at break | 300% – 700% | ASTM D412 |
| Tear strength | 20 – 50 kN/m | ASTM D624 |
| Clarity | High transparency (platinum-cured) | Visual inspection |
Sterilization Compatibility
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Autoclave (steam)
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Gamma irradiation
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Ethylene oxide (EtO)
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Repeated cycles without degradation
Applications in Healthcare, Bioprocessing & Beyond
Medical Devices & Healthcare
Engineers select our medical grade silicone tubing for:
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Drug delivery systems – Smooth internal surfaces reduce biofilm formation.
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Dialysis – Consistent ID/OD ensures accurate fluid flow rates.
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Peristaltic pumps – Excellent flex life and kink resistance.
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Bioprocessing – Low extractables protect cell cultures and biologics.
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Wound drainage – Biocompatible for short-term patient contact.
For procurement managers: Proven biocompatibility (USP Class VI) and certified material traceability simplify risk assessments and regulatory audits.
Food & Beverage Industry
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NSF 51 certified tubing – Meets global standards for non-toxicity.
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Temperature resistance – From deep freeze (-60°C) to hot-fill processes (200°C).
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Odorless and tasteless – No flavor transfer to sensitive products.
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Long service life – Minimizes downtime and equipment replacement costs.
Compliance & Procurement Benefits
Organizations that standardize on our platinum cured silicone tubing achieve:
| Benefit | How We Deliver |
|---|---|
| Robust regulatory compliance | USP Class VI, FDA, NSF 51, ISO 13485 |
| Audit-ready documentation | COA, batch traceability, regulatory package |
| Reduced maintenance & downtime | Longer tubing lifespan, kink resistance |
| Consistent quality | Batch-to-batch variability minimized via platinum-curing |
| Lower total cost of ownership | Fewer change-outs, less scrap, predictable performance |
For engineers: Validated safety and high material performance.
For procurement managers: Regulatory clarity and long-term supply stability.
How to Order Custom Silicone Tubing for Medical Usage
We support B2B procurement from prototype to production scale.
Request a Quote – Provide the Following:
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Inner Diameter (ID) and Outer Diameter (OD) – with tolerance requirements
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Length per unit / coil / spool – and total annual volume (estimated meters)
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Shore A hardness (30–80, or specify)
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Targeted application (e.g., peristaltic pump, drug delivery, bioprocessing)
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Certifications required (USP Class VI, ISO 10993, FDA, NSF 51)
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Sterilization method (autoclave, gamma, EtO – if pre-sterilized needed)
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Any extractables/leachables (E&L) testing requirements
Ordering Options
| Option | Details |
|---|---|
| Minimum order quantity (MOQ) | Low MOQ available for prototyping (e.g., 50 meters). Scale to 10,000+ meters for production. |
| Custom extrusion | ID/OD, wall thickness, length, color (upon request), printing/laser marking for traceability |
| Packaging | Coiled, spooled, cut-to-length, individually bagged (cleanroom optional) |
| Documentation | COA, batch traceability, USP Class VI test report, FDA declaration, NSF certificate |
| Lead time | 10–15 business days for custom sizes (expedite available) |
Frequently Asked Questions (FAQ)
Q: Can you provide USP Class VI and ISO 10993 test reports?
A: Yes. We provide full documentation including cytotoxicity, sensitization, and implantation test results. Request our compliance package for audits.
Q: What is your MOQ for custom medical tubing?
A: We offer low MOQs (e.g., 50 meters) for prototyping and scale to 10,000+ meters for production volumes. Bulk silicone tubing for medical devices is our specialty.
Q: Do you offer silicone tubing with laser marking or printing?
A: Yes. Custom printing (lot numbers, size, FDA/NSF markings) is available for traceability.
Q: What is the difference between peroxide vs platinum cured silicone tubing for medical use?
A: Platinum-cured leaves no benzene derivatives or acidic residues, making it safer for patient contact and pharmaceutical processing. Peroxide-cured is not recommended for high-purity applications.
Q: Can you meet my specific ID OD tolerance requirement?
A: Our standard tolerance is ±0.13 mm or better. Tighter tolerances (e.g., ±0.05 mm) are available upon engineering review.
Q: Do you support third-party audits?
A: Yes. Our facility is ISO 13485:2016 certified. We welcome supplier audits from regulated medical device companies.
Ready to Source Platinum Cured Silicone Tubing for Your Medical Application?
Get a quote for custom tubing →
Tell us your ID, OD, length, and volume. We’ll respond within 24 business hours with pricing, lead time, and compliance documentation.