Biopharmaceutical flexible hoses is a type of silicone tubing specifically designed to meet the requirements of biopharmaceutical processes. Manufactured using high-purity silicone raw materials and platinum vulcanization technology, it meets stringent requirements for sterility, biocompatibility, extremely low extractables/leachables, chemical compatibility, and sterilizability, ensuring drug safety.
Biopharmaceutical Hoses Features
Ultimate Biocompatibility
Made from high-purity materials (such as platinum-cured silicone rubber and fluorocarbon rubber), these tubing products have obtained biocompatibility certifications such as USP Class VI and ISO 10993. They ensure no toxic substances are released when in contact with cell culture media or pharmaceutical solutions, thereby protecting the integrity of bioactive components.
01
Ultra-low extractables/leachables (E&L)
Through rigorous E&L studies, it has been verified that the release of chemicals under sterilization or solvent contact conditions is extremely low, avoiding contamination of sensitive process fluids and ensuring drug safety and stability.
02
Comprehensive chemical compatibility
Resistant to strong acids, strong alkalis, organic solvents, and detergents (such as CIP/SIP solutions), preventing swelling, corrosion, or degradation, and adapting to complex pharmaceutical process environments.
03
Reliable Sterilization Performance
Supports multiple sterilization methods including high-temperature steam sterilization (above 121°C), gamma irradiation, and ethylene oxide, maintaining structural stability and functionality to meet sterile production requirements.
04
High cleanliness and low adsorption
Smooth inner walls with no dead corners (Ra value < 0.8 μm) reduce particle shedding and protein adsorption, facilitating cleaning and minimizing cross-contamination risks, in compliance with GMP cleanliness standards.
05
Pharma-Grade Flexible Hoses Applications
Drug delivery and transfer
Used for transporting liquid drugs, buffers, culture media, etc., ensuring sterile and efficient fluid transfer.
Single-Use Systems
The tubing is widely used in single-use biopharmaceutical processes, reducing cleaning and sterilization costs while minimizing cross-contamination risks. It is suitable for the production of monoclonal antibodies, vaccines, cell therapies, and gene therapies.
Medical Devices and Equipment
Used in minimally invasive medical devices such as catheters and balloon catheters, meeting precise dimensional and biocompatibility requirements.
Fluid Management
Used in biopharmaceutical production for filling machines, filtration systems, water treatment, and water purification systems, ensuring low leaching, low adsorption, and high safety.
Laboratory and Research
Supports liquid transfer in experiments, particularly suitable for the transportation of corrosive or sensitive liquids due to its self-priming capability and flexibility.
About Us
We are a Dongguan, China-based company with over 15 years of experience in manufacturing high-quality silicone tubing. Our 5,000-square-meter factory, staffed with 160 employees including 30 R&D engineers, offers strong design and innovation capabilities. Equipped with advanced automated production lines and precision testing equipment, we cover the full production process-extrusion, braiding, platinum vulcanization, molding, and pressure testing-ensuring compliance with international quality standards. Our products serve industries like medical devices, food and beverage, biopharmaceuticals, hydrogen-powered vehicles, and industrial equipment, with OEM/ODM customization available.
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