Pharmaceutical transfer hose
USP Class VI silicone and PTFE hoses for pharmaceutical and biotech processing. Validated cleanability for sterile manufacturing.
Best for: sterile drug manufacturing, biotech processing, API transfer, clean-room filling lines
USP Class VI silicone hose
Our platinum-cured USP Class VI silicone hose is the standard for pharmaceutical transfer applications. It is biologically tested for non-cytotoxicity and non-pyrogenicity, making it suitable for direct contact with drug products and sterile process fluids.
The ultra-smooth bore prevents bacterial harborage and facilitates CIP/SIP cleaning. The translucent silicone cover allows visual flow monitoring, while the platinum-cured construction provides superior cleanability compared to peroxide-cured alternatives. Supplied with full lot traceability and validation documentation for regulatory submission.
Challenges solved by pharmaceutical-grade hoses
Hose leaching in sterile processes
Standard transfer hoses can leach plasticizers, antioxidants, and oligomers into pharmaceutical fluids, compromising product purity and failing regulatory inspections. Our USP Class VI platinum-cured silicone hoses have extremely low extractables and are tested per USP <661> — ensuring zero cytotoxic or pyrogenic contamination in sterile manufacturing.
Cleanability validation failures
Pharmaceutical inspectors require validated cleaning protocols for all product-contact surfaces. Rough inner surfaces and porous hose materials trap residues, leading to cleaning validation failures and costly requalification. Our silicone hoses feature a mirror-finish smooth bore and are designed for SIP/CIP cycles with documented cleanability data to support your validation package.
Particle shedding from hose inner surface
In sterile filling operations, particulates shed from the hose inner wall can contaminate injectable products, causing batch rejection. Our platinum-cured silicone hose has a non-shedding, non-particulating inner surface that meets USP <788> requirements for particulate matter in injectables.
Case study: Indian pharmaceutical manufacturer
How switching to USP Class VI silicone hose resolved sterility validation failures in a sterile injectables facility.
Situation: A sterile injectables manufacturer in Hyderabad was failing sterility validation on their transfer lines due to extractables from non-certified hoses. The rubber hoses in use were leaching zinc-based accelerators into the drug product, causing repeated regulatory observations during cGMP audits.
Solution: Replaced all product-contact hoses with platinum-cured USP Class VI silicone hoses, including full extractables documentation and lot traceability. The hoses were qualified for SIP at 135°C and CIP with WFI (water for injection).
Outcome: Passed sterility validation on the first attempt. Subsequent regulatory audit observations reduced to zero. The plant now uses USP Class VI silicone as their standard for all sterile transfer applications.
Related food-grade applications
Pharmaceutical transfer hose FAQ
USP Class VI is the highest level of biological testing for plastics per the United States Pharmacopeia. It requires the material to pass systemic injection, intracutaneous injection, and implantation tests — meaning it is non-cytotoxic, non-pyrogenic, and biocompatible for pharmaceutical and medical use. A USP Class VI hose is suitable for direct contact with drug products, sterile fluids, and living tissues.
Yes. Our platinum-cured USP Class VI silicone hoses tolerate steam-in-place (SIP) at up to 135°C for 30-minute cycles and autoclave sterilization at 121°C indefinitely. PTFE-lined hoses can handle even higher temperatures. The number of sterilization cycles depends on the hose construction — silicone typically withstands 50–100 SIP cycles before replacement is recommended.
Our platinum-cured silicone hoses have very low extractables profiles and meet USP <661> and <87>/<88> requirements for non-cytotoxicity. However, no hose is truly non-extractable — extractables depend on the fluid contact conditions including temperature, contact time, and solvent properties. We can provide extractables data from our validation documentation for regulatory submissions. For the lowest extractables, we recommend PTFE-lined hoses which have near-zero extractables in most pharmaceutical solvents.
Need USP Class VI hoses for pharmaceutical processing?
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