Food Grade Platinum Cured Silicone Tubing
FDA-compliant platinum-cured silicone tubing for food, beverage, dairy & drinking water. Odorless, tasteless, high transparency. ID 0.5-50mm. Custom sizes. Request quote
Silicone Tubing & Hose Products
Five product families of platinum-cured silicone, engineered for food, pharmaceutical, biotech and industrial fluid transfer. Select a category to view the full product list.
Silicone Tubing（纯硅胶管）
Pharma Grade Silicone Tubing (USP Class VI)
USP Class VI platinum-cured silicone tubing for pharmaceutical & biotech. Low extractables, biocompatible, gamma sterilizable. ID 0.5-50mm. GMP compliant.
USP Class VI ISO 10993 REACH
Product Overview
Rekky Technology’s Pharma Grade Silicone Tubing is manufactured to the highest standards for pharmaceutical, biotechnology, and medical device applications. Certified to USP Class VI and ISO 10993 biocompatibility standards, this tubing ensures the utmost safety when in contact with drugs, biological media, and sensitive therapeutic products.
Produced in a controlled clean-room environment using platinum (addition) curing, our pharma-grade tubing exhibits exceptionally low levels of extractables and leachables — critical for maintaining drug purity and meeting regulatory requirements from the FDA, EMA, and other global agencies. The ultra-smooth inner surface minimizes protein binding and cell adhesion, making it ideal for single-use systems (SUS), bioreactors, and aseptic filling lines.
Each production batch is fully traceable from raw material lot to finished product, with comprehensive Certificates of Analysis (COA) provided. The tubing supports multiple sterilization methods including autoclave, gamma irradiation, ethylene oxide (EtO), and steam-in-place (SIP), giving you maximum flexibility in your validation protocols.
Technical Specifications
| Material | Pharma-grade platinum-cured silicone (VMQ) |
|---|---|
| Curing Process | Platinum addition-cured in clean-room conditions |
| Hardness (Shore A) | 50–70 (customizable) |
| Inner Diameter (ID) | 0.5 mm – 50 mm |
| Outer Diameter (OD) | 1.5 mm – 60 mm |
| Working Temperature | -40°C to +220°C |
| Tensile Strength | ≥ 8.0 MPa |
| Elongation at Break | ≥ 350% |
| Tear Strength | ≥ 18 kN/m |
| Extractables | Extremely low — batch-tested |
| Surface Finish | Ultra-smooth, Ra ≤ 0.8 μm |
| Sterilization Methods | Autoclave, Gamma, EtO, SIP, CIP |
| Packaging | Double-bagged in PE, clean-room packed |
| Certifications | USP Class VI, ISO 10993, FDA, REACH |
Structure & Cross-Section
Rekky Technology’s Pharma Grade Silicone Tubing is manufactured to the highest standards for pharmaceutical, biotechnology, and medical device applications. Certified to USP Class VI and ISO 10993 biocompatibility standards, this tubing ensures the utmost safety when in contact with drugs, biological media, and sensitive therapeutic products.
Key Features & Advantages
USP Class VI and ISO 10993 biocompatibility certified
Extremely low extractables and leachables profile
Ultra-smooth inner surface minimizes protein binding
Full batch traceability from raw material to finished goods
Compatible with all major sterilization methods
No plasticizers, fillers, or additives
Resistant to a wide range of pharmaceutical media
Available with Certificate of Analysis (COA) per batch
Applications
Biopharma Transfer
Cell culture media, buffers, and WFI line transfer under cleanroom conditions
Vaccine & API Production
High-purity fluid transfer for vaccine and active pharmaceutical ingredient lines
Injectable & Infusion
Non-pyrogenic transfer for injectable and infusion manufacturing
Laboratory & Analytical
HPLC, reagent, and sampling lines requiring USP Class VI materials
Compliance & Certifications
USP Class VI ISO 10993 REACH
Every Rekky Pharma Grade Silicone Tubing (USP Class VI) is manufactured under ISO 9001-controlled processes with full batch traceability and Certificates of Analysis (COA) on request.
Rekky vs Standard Alternative
| Pharma Grade Silicone Tubing (USP Class VI) | Rekky | Standard Alternative |
|---|---|---|
| Biocompatibility | USP Class VI + ISO 10993 | FDA 21 CFR 177.2600 |
| Extractables Testing | Batch-specific COA | General compliance |
| Production Environment | Clean-room controlled | Standard GMP |
| Surface Finish | Ultra-smooth (Ra ≤ 0.8 μm) | Smooth |
| Packaging | Double-bagged, clean-room | Standard PE film |
| Traceability | Full lot-to-lot | Batch level |
| Price Level | Premium | Standard |
Frequently Asked Questions
Yes. It is tested per USP <88> Class VI for implantation and systemic toxicity, with documentation supplied on request.
We can supply extractables profiles aligned with ISO 10993 and BPOG best practices upon request.
Yes. It withstands SIP up to 134°C for 30 minutes and autoclave cycles at 121°C.
Yes. The platinum-cured VMQ base contains no animal-derived components.
Yes. A Certificate of Analysis and material compliance statement accompany every lot.
Request a Quotation or Sample
Our team typically responds within 24 hours. Please provide your required dimensions, quantity, and application for an accurate quotation.
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