Specialties Company supplies biopharma manufacturing hose and bioprocess tubing assemblies for upstream, downstream, fill-finish and utility service — built from validated materials and supplied with the documentation your quality group will ask for before the assembly ever reaches the floor.
Materials Built for Bioprocess
- Platinum cured silicone hose — low extractables and leachables, excellent flex life, the workhorse for peristaltic pumping and transfer
- Smooth bore PTFE — chemically inert, non-leaching, ideal for solvents, aggressive buffers and high-temperature steps
- Braided and reinforced silicone for pressure and full-vacuum service
- TPE and thermoplastic tubing for sterile welding and disposable flow paths
- Single use assemblies for closed, disposable process trains
Documentation Package
Tell us what your QA group requires and we quote it into the assembly rather than chasing it later:
- USP Class VI compliance
- FDA 21 CFR 177 material compliance
- ISO 10993 biocompatibility data
- Animal-derived component free (ADCF) statements
- Extractables and leachables data packages
- Material certificates, lot traceability and certificates of conformance
Sanitary Connections and Build Detail
Tri-Clamp is standard, with the gasket material specified to your process. We also build hygienic threaded connections, sanitary flanges, barbed and hose-tail configurations for pump connections, and custom end combinations. Assemblies are designed without dead legs or entrapment areas so they drain and clean properly.
Where These Assemblies Run
Media and buffer preparation, bioreactor feed and harvest, chromatography and filtration skids, TFF systems, CIP and SIP circuits, WFI and purified water distribution, formulation, and filling and dispensing lines.
Cleaning, Packaging and Sterilization
Assemblies can be supplied cleaned, capped and double-bagged for cleanroom entry, and specified for autoclave or gamma sterilization compatibility. Tell us the cleaning protocol, packaging level and sterilization method your SOP calls for and we will quote to it.
Request a Quote
Send size, end connections, process step and required documentation using the form above, or call (979) 233-6223. Our team replies with pricing and lead time, usually within 1–2 business hours.