Biotech Silicone Hose | Low-Extractable Platinum-Cured | Single-Use Systems | Rekky
API transfer, clean-room processes & sterile filling
Industry Overview
Biotechnology processes are among the most sensitive in modern manufacturing. Cell cultures, viral vectors, and recombinant proteins can be compromised by even trace levels of leachables from tubing materials. As the industry increasingly adopts single-use systems (SUS) to eliminate cross-contamination and reduce cleaning validation burden, the quality of disposable components has become a critical success factor.
Rekky Technology’s biotech-grade silicone hoses are engineered for the unique demands of cell culture, fermentation, and downstream purification. Our platinum-cured silicone delivers the lowest extractables profile available — essential for maintaining cell viability and product titer. The ultra-smooth inner surface minimizes cell adhesion and protein binding, while the full vacuum capability of our reinforced hoses supports efficient harvest operations.
Every batch is manufactured in clean-room conditions with full lot-to-lot traceability. We provide comprehensive documentation including extractables data, biocompatibility certificates, and sterilization validation guides — everything your quality team needs to support IND, BLA, or CMC filings.
Whether you are producing monoclonal antibodies, gene therapy vectors, or vaccine components, Rekky provides the purity-assured fluid transfer solutions that protect your biological products and accelerate your path to market.
Compliance & Certifications
- USP Class VI — Full biocompatibility testing
- ISO 10993 — Biological evaluation series
- BPOG Extractables Protocol — Best practices for extractables testing (on request)
- Gamma Sterilization Validated — Up to 50 kGy
- USP <661.1> / <1661> — Plastic packaging systems and extractables
Industry Challenges & Solutions
| Challenge | Rekky Solution |
|---|---|
| Cell culture extremely sensitive to extractables | Platinum curing, ultra-low extractables |
| Single-use system (SUS) validation | Complete COA, E&L data, sterilization validation |
| Harvest stage vacuum operation | Steel wire reinforced hose, full vacuum no collapse |
| Protein adsorption loss | Ultra-smooth surface, low protein binding |
| Batch-to-batch consistency | Clean-room production, full batch traceability |
| Regulatory filing documentation | Supports IND/BLA/CMC submission packages |
Recommended Products
| Product | Application | Key Advantage |
|---|---|---|
| Pharma Grade Tubing | Cell culture media transfer | USP Class VI, ultra-low extractables |
| Peristaltic Pump Tubing | Precision feeding, filling | 10+ million cycles, precision flow |
| Steel Wire Reinforced Hose | Bioreactor harvest | Full vacuum, 316L wire |
| Vacuum Rated Hose | Depth filtration, centrifugation | 0 bar absolute vacuum |
| Tri-Clamp Assemblies | Single-use system connections | Pre-assembled, gamma compatible |
Key Applications
Cell Culture Media Transfer
Cell culture media are complex formulations containing growth factors, vitamins, and amino acids that can be degraded by leachables from tubing materials. Our platinum-cured tubing has been validated for extremely low extractables in water-for-injection (WFI) and cell culture media, ensuring that cell viability and product titer are maintained throughout the culture period.
Single-Use Bioreactors
SUS technology eliminates cleaning validation and reduces cross-contamination risk — but only if the disposable components are truly pure. Our pharma-grade tubing is widely used in SUS transfer lines, mixing bag connections, and sampling assemblies. We can supply gamma-sterilized, double-bagged tubing ready for aseptic connection.
Harvest & Downstream Processing
Cell harvest from bioreactors typically involves vacuum filtration or centrifugation, requiring hoses that maintain their shape under deep vacuum. Our Steel Wire Reinforced and Vacuum Rated hoses prevent collapse during harvest, ensuring efficient cell recovery and maintaining product yield.
Vaccine Production
Viral media and adjuvant solutions require tubing that will not adsorb viral particles or alter adjuvant stability. Our low-protein-binding surface minimizes viral loss during transfer, while the chemical inertness ensures adjuvant formulation integrity.
Frequently Asked Questions
We use platinum (addition) curing exclusively — no peroxide initiators that can leave acidic residues. Every batch is tested for volatile and non-volatile extractables, and we provide COA documentation with every shipment.
Yes. Our peristaltic pump tubing is specifically formulated for high-cycle perfusion applications, with enhanced abrasion resistance and low compression set to maintain consistent flow rates over extended culture periods.
Yes. We can provide tubing samples for your extractables and leachables (E&L) studies, along with material composition data and processing information to support your validation protocols.
Standard pharma-grade tubing: 2–3 weeks. Custom gamma-sterilized configurations: 3–4 weeks. We maintain safety stock for common biotech sizes to support urgent production schedules.
Related Products
- Pharma Grade Silicone Tubing
- Peristaltic Pump Tubing
- Steel Wire Reinforced Hose
- Vacuum Rated Silicone Hose
- Tri-Clamp Assemblies
Need tubing for Biotechnology?
Get a personalized recommendation and quote within 24 hours.