Pharmaceutical Silicone Hose | USP Class VI & GMP Compliant | Rekky
API transfer and clean room fluid handling.
Industry Overview
Pharmaceutical manufacturing leaves no room for compromise. Every material that contacts drugs, biological media, or therapeutic products must meet the most stringent biocompatibility and purity standards — USP Class VI, ISO 10993, and FDA 21 CFR 177.2600. Even trace levels of extractables or leachables can compromise drug efficacy, trigger regulatory rejection, or endanger patient safety.
Rekky Technology’s pharmaceutical-grade silicone hoses are manufactured in controlled clean-room environments using platinum (addition) curing — the purest silicone processing method available. With no peroxide by-products, no plasticizers, and no fillers, our tubing delivers the lowest extractables profile in the industry. Each production batch is fully traceable from raw material lot to finished product, with comprehensive Certificates of Analysis (COA) documenting compliance.
Our pharma-grade hoses support all major sterilization methods — autoclave, gamma irradiation, ethylene oxide (EtO), and steam-in-place (SIP) — giving you maximum flexibility in your validation protocols. The ultra-smooth inner surface (Ra ≤ 0.8 μm) minimizes protein binding and cell adhesion, making our tubing ideal for single-use systems (SUS), bioreactors, chromatography, and aseptic filling lines.
From small-molecule APIs to large-molecule biologics, Rekky provides the contamination-free fluid transfer solutions that protect product purity and accelerate regulatory approval.
Compliance & Certifications
- USP Class VI — United States Pharmacopeia biocompatibility (systemic toxicity, intracutaneous, implantation)
- ISO 10993 — Biological evaluation of medical devices
- FDA 21 CFR 177.2600 — Food-contact silicone standard
- EP 3.1.9 — European Pharmacopoeia rubber closures standard (on request)
- GMP Compliant — Manufactured under documented quality systems
- EN 10204 3.1 — Material certificates for stainless steel fittings
Industry Challenges & Solutions
| Challenge | Rekky Solution |
|---|---|
| Extractables/leachables contaminating drugs | USP Class VI + ISO 10993, ultra-low extractables |
| Strict batch traceability requirements | Full lot-to-lot traceability, COA per batch |
| Multiple sterilization method validation | Compatible with autoclave, gamma, EtO, SIP |
| Protein adsorption loss | Ultra-smooth surface: Ra ≤ 0.8 μm |
| Clean-room environment requirements | Manufactured in clean room, double-bagged |
| Regulatory audit documentation | Complete 3.1 material certs, COA, validation guides |
Recommended Products
| Product | Application | Key Advantage |
|---|---|---|
| Pharma Grade Tubing (USP Class VI) | API transfer, aseptic filling | Ultra-low extractables, clean-room packed |
| Braided Silicone Hose | Buffer, media pressurized delivery | 10 bar, full vacuum, no fiber shedding |
| Double Layer Braided Hose | High-pressure homogenization, filtration | 20 bar, superior pulsation fatigue |
| Peristaltic Pump Tubing | Precision filling, analytical instruments | 10+ million compression cycles |
| Tri-Clamp Assemblies | Single-use system connections | Pre-assembled, serialized, pressure tested |
Key Applications
Active Ingredient Transfer
API transfer lines demand tubing that will not adsorb valuable drug compounds or introduce contaminants. Our USP Class VI platinum-cured tubing has been validated for extremely low extractables across a wide range of pharmaceutical solvents, acids, and bases. Full batch traceability ensures that every meter of tubing can be traced back to its raw material lot — essential for FDA and EMA compliance.
Aseptic Filling
Vial and syringe filling lines operate under strict aseptic conditions where any particle contamination can result in batch rejection. Our pharma-grade tubing is manufactured in ISO Class 7 clean rooms, double-bagged in PE, and delivered with full COA documentation. The ultra-smooth inner surface prevents particle shedding, while gamma sterilization compatibility allows pre-sterilized tubing to be aseptically connected to filling machines.
Bioreactor & Fermentation
Cell culture media and fermentation broths are highly sensitive to contamination. Our platinum-cured tubing supports CIP/SIP sterilization protocols and maintains biocompatibility even after repeated autoclave cycles. The low-protein-binding surface minimizes cell loss during media transfer, while the full vacuum capability (with reinforced hoses) supports harvest operations.
Chromatography & Purification
Chromatography skids require tubing that will not interact with mobile phases or alter separation efficiency. Our pharma-grade tubing is chemically inert to common chromatography buffers and solvents, and the precise dimensional tolerance ensures consistent flow rates through purification columns.
Frequently Asked Questions
USP Class VI is the most stringent biocompatibility standard, requiring systemic toxicity, intracutaneous, and implantation testing. FDA 21 CFR 177.2600 is a food-contact standard that does not require the same level of biocompatibility documentation. For pharmaceutical applications, USP Class VI is the minimum requirement.
Yes. We provide batch-specific COAs that include extractables and leachables data. For critical applications, we can also arrange third-party testing by SGS, Intertek, or Toxikon with full study reports.
Yes. Our pharma-grade tubing withstands gamma irradiation up to 50 kGy without degradation. It is also compatible with autoclave (121°C), EtO, and SIP (134°C) sterilization.
Pharma grade tubing is produced in a more controlled environment with stricter biocompatibility testing (USP Class VI + ISO 10993), lower extractables limits, and full batch traceability. Food grade meets FDA 21 CFR 177.2600 but does not require the same level of biocompatibility documentation.
Yes. We provide comprehensive technical documentation including material certificates, COA, sterilization validation guides, and compatibility data to support your regulatory filing and process validation.
Yes, but for high-cycle peristaltic applications, we recommend our dedicated Peristaltic Pump Tubing which is formulated with enhanced abrasion resistance while maintaining USP Class VI compliance.
Related Products
- Pharma Grade Silicone Tubing
- Braided Silicone Hose
- Double Layer Braided Hose
- Peristaltic Pump Tubing
- Tri-Clamp Assemblies
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