316L BA Coil Tube for Biopharmaceutical Fermentation Tank Jacket
Product Overview
Wenzhou Jixing Metal Materials Co., Ltd. presents a premium-grade 316L Electropolished (BA) Coil Tube specifically engineered for jacketed fermentation tanks and internal coil configurations within biopharmaceutical manufacturing environments. This product is purpose-built to meet the rigorous demands of upstream bioprocessing, where precise temperature control of culture media (typically maintained between 30–37 °C) and the execution of frequent CIP (Clean-in-Place) and SIP (Sterilize-in-Place) cycles are non-negotiable requirements for product quality and regulatory compliance.
Unlike generic stainless steel tubing, this coil tube is designed to withstand the cumulative stresses of repeated thermal cycling, aggressive cleaning agents, and prolonged exposure to biological media without degradation of surface integrity, dimensional accuracy, or mechanical performance.
Material & Properties
The tube is fabricated from AISI 316L (UNS S31603) austenitic stainless steel, selected for its superior corrosion resistance, low carbon content, and excellent weldability—critical attributes for bioprocessing applications where metallic contamination must be minimized and material compatibility with acidic/alkaline cleaning solutions is paramount.
- Material Grade: 316L (UNS S31603 / EN 1.4404 / GB 022Cr17Ni12Mo2)
- Surface Finish: Electropolished BA (Bright Annealed) finish, interior and exterior
- Surface Roughness: Ra ≤ 0.8 μm (interior), ensuring minimal biofilm adhesion and ease of sanitization
- Mechanical Strength: Excellent resistance to repeated thermal shock cycles between ambient temperature and sterilization temperatures (up to 135 °C)
- Corrosion Resistance: Outstanding resistance to pitting and crevice corrosion from halide-containing CIP solutions (NaOH, HNO₃, peracetic acid)
- Hygienic Design: Smooth, non-porous surface eliminates dead legs and harboring points for microbial contamination
Specifications
| Parameter | Specification |
|---|---|
| Material Grade | 316L (UNS S31603) |
| Surface Finish | Electropolished / BA (Bright Annealed) |
| Interior Surface Roughness (Ra) | ≤ 0.8 μm |
| Exterior Surface Roughness (Ra) | ≤ 1.2 μm |
| Tube Configuration | Continuous Coil (helical or spiral winding) |
| Temperature Range | −40 °C to +450 °C (continuous); SIP cycles up to 135 °C |
| Operating Pressure | Up to 1.0 MPa (configurable per application) |
| Thermal Shock Resistance | Withstands repeated cycles between 20 °C and 135 °C without cracking or deformation |
| Outer Diameter Range | Φ6 mm – Φ25 mm (standard); custom sizes available |
| Wall Thickness Range | 0.5 mm – 2.0 mm (customizable) |
| Coil Winding Pitch | Customizable per tank geometry and heat transfer requirements |
| End Preparation | Beveled, flat, or threaded per customer specification |
| Welding Compatibility | TIG/Orbital welding compatible; weld seams pass helium leak testing |
Manufacturing Process
Every coil tube produced by Wenzhou Jixing undergoes a tightly controlled manufacturing sequence to guarantee dimensional precision, surface quality, and material integrity:
- Raw Material Selection: Certified 316L stainless steel seamless tube sourced from approved mills, with full chemical composition verification (spectroscopic analysis) and mechanical property testing.
- Tube Cutting & Straightening: Precision cutting to specified lengths followed by mechanical straightening to achieve ±0.1 mm tolerance on flatness.
- Precision Coiling: Computer-controlled CNC coiling machines wind the straight tube into the exact helical or spiral geometry required for the target fermentation tank, ensuring uniform coil pitch and consistent bend radius to prevent localized stress concentrations.
- Surface Conditioning: Multi-stage chemical cleaning and passivation to remove scale, oils, and processing residues, establishing a stable chromium oxide passive layer.
- Electropolishing / Bright Annealing: Electrochemical polishing (or controlled furnace bright annealing) reduces interior surface roughness to Ra ≤ 0.8 μm, eliminating micro-scratches, grinding marks, and surface imperfections that could harbor microbial growth.
- Dimensional Inspection: Full geometric verification including outer diameter, wall thickness, coil pitch, bend radius, and overall dimensions using calibrated measuring instruments and CMM (Coordinate Measuring Machine) where applicable.
- Non-Destructive Testing (NDT): 100% visual inspection; helium leak testing on welded joints; optional eddy current testing for wall thickness uniformity and surface defect detection.
- Packaging & Protection: Each coil is individually wrapped in food-grade protective film, placed in a ventilated wooden crate or export-grade container, and accompanied by a full material traceability document.
Applications
This 316L BA coil tube is specifically designed for the following biopharmaceutical and related process applications:
- Fermentation Tank Jackets: Integral cooling/heating coil systems surrounding the vessel wall to maintain precise culture medium temperature (30–37 °C) during microbial or cell culture growth phases.
- Internal Coil Configurations: Immersed coil assemblies within bioreactors for enhanced heat transfer efficiency in high-density fermentation processes.
- Seed Tanks & Upstream Processing: Temperature control for inoculum preparation, shake flask scale-up, and downstream purification equipment.
- CIP/SIP Systems: The tube's surface finish and material composition are fully compatible with automated cleaning and sterilization cycles using caustic soda, nitric acid, peracetic acid, and steam at 121–135 °C.
- Vaccine Production & Biologics: Applications in monoclonal antibody manufacturing, recombinant protein production, and live attenuated vaccine development where GMP compliance is mandatory.
- Food & Beverage Processing: Temperature-controlled tanks for fermentation of dairy, beer, and specialty food products requiring hygienic-grade stainless steel.
Quality Certifications & Compliance
Wenzhou Jixing Metal Materials Co., Ltd. maintains rigorous quality management systems to ensure every product meets international regulatory and industry standards:
- ISO 9001:2015 — Quality Management System certification ensuring consistent manufacturing quality and process control.
- ISO 14001 — Environmental Management System compliance for sustainable and responsible production practices.
- ISO 22000 / HACCP — Food safety management system applicable to food-grade stainless steel components.
- ASME BPE — Compliance with Bioprocessing Equipment guidelines for surface finish, weld quality, and hygienic design principles.
- 3-A Sanitary Standards — Product design aligned with American Dairy Sanitary Engineering Association standards for bioprocessing equipment.
- EU GMP Annex 1 — Design suitability for facilities operating under European Union Good Manufacturing Practice regulations.
- US FDA 21 CFR Part 117 — Material and surface finish compliance with U.S. Food and Drug Administration regulations for food-contact surfaces.
- Full Material Traceability: Each coil tube is accompanied by a Material Test Certificate (MTC) per EN 10204 Type 3.1, a heat treatment report, surface roughness test report, and dimensional inspection certificate.
Unique Selling Points
1. Purpose-Built for Bioprocessing: Unlike general-purpose stainless steel coil tubes, this product is engineered specifically for the unique demands of fermentation tank jacket applications—combining hygienic surface quality, thermal shock resilience, and CIP/SIP compatibility in a single product solution.
2. Ultra-Smooth Interior Surface (Ra ≤ 0.8 μm): The electropolished finish dramatically reduces the risk of biofilm formation and microbial contamination, ensuring consistent product quality across repeated production batches and minimizing cleaning validation complexity.
3. Superior Thermal Shock Durability: The 316L grade, combined with controlled manufacturing processes, ensures the coil tube maintains structural integrity and dimensional accuracy through thousands of sterilization cycles—extending service life and reducing unplanned maintenance downtime.
4. Full Traceability & Documentation: Every product ships with comprehensive documentation packages including MTC 3.1, surface finish verification, and dimensional inspection reports—streamlining customer audit processes and regulatory submissions.
5. Custom Engineering Capability: Wenzhou Jixing offers full customization of coil geometry, tube dimensions, end preparations, and surface specifications to match specific tank designs and process requirements, supported by experienced engineering teams and advanced CNC manufacturing infrastructure.
Company Profile
Wenzhou Jixing Metal Materials Co., Ltd. is a specialized manufacturer of precision stainless steel tubing, coil tubes, and hygienic process components serving the biopharmaceutical, food & beverage, medical device, and chemical processing industries. With state-of-the-art manufacturing facilities, stringent quality control protocols, and a commitment to customer-specific engineering solutions, Wenzhou Jixing delivers reliable, compliant, and high-performance stainless steel products that meet the most demanding international standards.