# Bioprocess tubing Platinum-cured silicone and high-purity thermoplastic elastomer (TPE) tubing engineered for fluid transfer in biopharmaceutical manufacturing — a raw material/component consumable distinct from the fully integrated single-use assemblies it gets built into — sold by four specialist tubing extruders (AdvantaPure, Freudenberg Medical, Saint-Gobain Critical Process Solutions, Raumedic) rather than the systems integrators who assemble tubing into pre-sterilized flow paths. Source: https://en.bioecon.ru/technology/bioprocess-tubing/ Updated: 2026-08-19 ## Overview and value chain Markers: [EC: EU GMP Annex 1 (sterile manufacturing) | OECD: Industrial biotechnology | Regulator: FDA (USA), EMA (EU)] Bioprocess tubing is the extruded silicone or thermoplastic-elastomer (TPE) hose that carries process fluids — cell culture media, buffers, bulk drug substance — between vessels, filters and other equipment in a biopharmaceutical manufacturing line. The category is a raw-material/component consumable, distinct from the fully integrated single-use assemblies (pre-sterilized flow paths combining tubing, connectors and bags into a validated kit, already a separate vendor category in this catalog) that get built from it: a tubing extruder sells the hose itself, while a systems integrator buys tubing as one input among several to build a complete pre-sterilized assembly. The category splits between platinum-cured silicone tubing, the traditional material offering flexibility and steam-sterilization compatibility, and newer high-purity TPE formulations marketed as a lower-extractables, more consistent-wall-thickness alternative. A further sub-category, braided or reinforced tubing, addresses higher-pressure pump and transfer applications where unreinforced tubing would collapse or burst. The key directions of bioprocess tubing are: 1. **Platinum-cured silicone tubing:** the traditional bioprocess tubing material, offering flexibility, steam-sterilization compatibility and a long track record in pump and transfer applications. 2. **High-purity TPE tubing:** thermoplastic-elastomer tubing formulations marketed as an alternative to silicone with lower extractables and more consistent wall thickness for critical fluid-transfer applications. 3. **Braided/reinforced bioprocess hose:** tubing reinforced with a braided layer for higher-pressure pump and transfer applications where unreinforced tubing would be unsuitable. 4. **Cleanroom-manufactured tubing for single-use assembly integration:** tubing extruded and packaged under cleanroom conditions specifically for downstream integration into pre-sterilized single-use assemblies by systems integrators. ### Sectoral value chain ``` [Polymer Resin/Silicone] ──> [Extrusion] ──> [Cleanroom Packaging] ──> [Quality Release] │ (Reinforcement/Braiding) │ ▼ [Process Fluid Transfer] <─── [SUA Integration or Direct Sale] <─────┘ ``` ### Value chain levels | Level | Description | Key inputs/outputs | |:---|:---|:---| | **Polymer resin/silicone** | Sourcing the platinum-cured silicone elastomer or TPE resin feedstock. | **In:** Silicone elastomer or TPE resin.
**Out:** Feedstock ready for extrusion. | | **Extrusion** | Extruding the tubing to target diameter, wall thickness and (where specified) braided reinforcement. | **In:** Polymer feedstock.
**Out:** Extruded tubing at target dimensions. | | **Cleanroom packaging** | Packaging the extruded tubing under cleanroom conditions to the purity level the application requires. | **In:** Extruded tubing.
**Out:** Cleanroom-packaged tubing. | | **Quality release** | Releasing the tubing against extractables/leachables and dimensional specifications. | **In:** Cleanroom-packaged tubing.
**Out:** QC-released tubing product. | | **SUA integration or direct sale** | Tubing either sold directly to an end user or supplied as a component to a single-use-assembly systems integrator. | **In:** Released tubing.
**Out:** Tubing ready for direct process use or SUA integration. | | **Process fluid transfer** | The tubing in service, carrying process fluid between vessels and equipment in the manufacturing line. | **In:** Installed tubing, process fluid.
**Out:** Transferred process fluid. | Cross-cutting technologies of the sector: - **Platinum-cured silicone tubing:** the traditional flexible, steam-sterilizable bioprocess tubing material. - **High-purity TPE tubing:** thermoplastic-elastomer tubing marketed for lower extractables and more consistent wall thickness than silicone. - **Braided/reinforced bioprocess hose:** tubing reinforced for higher-pressure pump and transfer applications. --- ## US The United States hosts the tubing specialist whose branded product lines span both the traditional silicone and newer TPE material categories. ### Silicone and TPE tubing product lines - **AdvantaPure:** manufactures the AdvantaSil platinum-cured silicone tubing line and the AdvantaFlex/AdvantaBio EcoFlex high-purity TPE tubing lines, covering both major tubing material categories under one brand with continuing new-product releases such as an updated silicone pump tubing variant. --- ## CN China's presence in bioprocess tubing is limited to general medical/pharmaceutical tubing market coverage rather than a confirmed dedicated bioprocess-grade tubing producer: no domestic company's own-domain page confirming a specific platinum-cured silicone or high-purity TPE bioprocess tubing product was found in this screen. ### Market coverage only, no confirmed dedicated producer - **General market visibility only:** searches return industry reporting on China's medical-tubing manufacturing sector rather than a specific domestic company's own commercial bioprocess-grade tubing product page. - **No producer tabled:** without an own-domain page confirming a specific Chinese company's bioprocess tubing product, none is listed here — an evidence gap to revisit as the category develops, not a claim that Chinese tubing manufacturers are absent generally. --- ## EU Europe hosts three specialists spanning premium silicone tubing with dedicated cleanroom manufacturing, a critical-fluid-transfer product line from a major materials group, and a German extruder with the broadest branded product range in the category. ### Cleanroom-manufactured silicone, critical-fluid-transfer TPE, braided/reinforced product lines - **Freudenberg Medical (Germany):** produces the PharmaFocus premium silicone tubing line and operates a dedicated ISO Class 5 cleanroom specifically for pre-sterilized single-use assembly manufacturing, positioning its tubing supply alongside in-house cleanroom capability for downstream integration. - **Saint-Gobain Critical Process Solutions (France):** produces the PharmaPure TPE tubing line, marketed explicitly around product purity for bioprocessing and biotech fluid-transfer applications. - **Raumedic (Germany):** produces the broadest branded tubing range in the category — BRAIDMOTION braided silicone tubing, SILMOTION platinum-cured silicone tubing and THERMMOTION TPE tubing — spanning all three major tubing sub-categories under one manufacturer. --- ## Leading companies and research institutes | Company / Institute | Country | Key products / platforms | Tech features | Status 2026 | |:---|:---|:---|:---|:---| | **AdvantaPure** | 🇺🇸 USA | *AdvantaSil silicone, AdvantaFlex/AdvantaBio TPE tubing* | Covers both silicone and TPE material categories under one brand | commercial | | **Freudenberg Medical** | 🇩🇪 Germany | *PharmaFocus premium silicone tubing* | Dedicated ISO Class 5 cleanroom for downstream SUA integration | commercial | | **Saint-Gobain Critical Process Solutions** | 🇫🇷 France | *PharmaPure TPE tubing* | Purity-focused bioprocessing/biotech fluid-transfer tubing | commercial | | **Raumedic** | 🇩🇪 Germany | *BRAIDMOTION, SILMOTION, THERMMOTION tubing lines* | Broadest branded range: braided silicone, platinum-cured silicone, TPE | commercial | --- ## Tech stack and innovations The stack splits into the two dominant tubing materials (silicone and TPE) plus a reinforcement layer that addresses higher-pressure applications neither base material alone can handle unaided. 1. **Platinum-Cured Silicone Tubing:** - The traditional bioprocess tubing material, valued for flexibility and steam-sterilization compatibility, produced by all four vendors in some form (AdvantaSil, PharmaFocus, SILMOTION). - Raumedic's SILMOTION and AdvantaPure's AdvantaSil both continue active product development within this established material category rather than treating it as a mature, unchanging product line. 2. **High-Purity TPE Tubing:** - Marketed as a lower-extractables, more dimensionally consistent alternative to silicone, produced by AdvantaPure (AdvantaFlex/EcoFlex), Saint-Gobain (PharmaPure) and Raumedic (THERMMOTION). - Three of the four vendors in this category offer both silicone and TPE lines rather than specializing in one material exclusively, reflecting that end users typically choose material by application rather than by vendor. 3. **Braided/Reinforced Bioprocess Hose:** - Raumedic's BRAIDMOTION line addresses higher-pressure pump and transfer applications where unreinforced silicone or TPE tubing would be unsuitable, a distinct engineering solution from simply thickening the tubing wall. - This sub-category is the least commoditized of the three, with reinforcement construction representing genuine engineering differentiation beyond base material chemistry. --- ## Value chains and production pipelines ### Industrial pipeline of a bioprocess tubing product (FDA, EMA oversight) ``` ┌───────────────────────────┐ ┌───────────────────────────┐ │ 1. Polymer Resin/Silicone │ ───> │ 2. Extrusion │ └───────────────────────────┘ └───────────────────────────┘ │ ▼ ┌───────────────────────────┐ ┌───────────────────────────┐ │ 4. Quality Release │ <─── │ 3. Cleanroom Packaging │ └───────────────────────────┘ └───────────────────────────┘ │ ▼ ┌───────────────────────────┐ ┌───────────────────────────┐ │ 5. SUA Integ. or Direct Sale│ ───> │ 6. Process Fluid Transfer │ └───────────────────────────┘ └───────────────────────────┘ ``` #### Stage 1: Polymer resin/silicone Platinum-cured silicone elastomer or TPE resin is sourced as the feedstock, the material choice that determines which of the two major product families the finished tubing belongs to. #### Stage 2: Extrusion The feedstock is extruded to target diameter and wall thickness, with braided reinforcement added at this stage for the reinforced-hose sub-category. #### Stage 3: Cleanroom packaging The extruded tubing is packaged under cleanroom conditions to the purity level its intended application requires, a step directly relevant to vendors like Freudenberg Medical that also operate downstream single-use-assembly cleanrooms. #### Stage 4: Quality release The tubing is released against extractables/leachables testing and dimensional specifications before it can be sold for GMP process use. #### Stage 5: SUA integration or direct sale The released tubing is either sold directly to an end user for direct process installation or supplied as a component to a single-use-assembly systems integrator building a complete pre-sterilized flow path. #### Stage 6: Process fluid transfer The tubing enters service, carrying process fluid between vessels and equipment in the manufacturing line, the functional end point the entire upstream production chain exists to reach.