316L BA Stainless Steel Coil Tube for Biopharmaceutical Fermentation Tank Jackets
Product Overview
This premium-grade 316L electropolished (BA finish) stainless steel coil tube is purpose-engineered for use as jacketed coil tubing within biopharmaceutical fermentation tanks. Designed to meet the rigorous demands of upstream bioprocessing, this coil tube ensures precise temperature control of culture media within the critical range of 30–37°C while withstanding frequent and aggressive CIP (Clean-In-Place) and SIP (Sterilize-In-Place) cycles without degradation of surface integrity or mechanical performance. Manufactured by Wenzhou Jixing Metal Materials Co., Ltd., this product represents a benchmark in sanitary-grade process tubing for the biopharmaceutical industry.
Material & Properties
The coil tube is fabricated from Type 316L austenitic stainless steel, selected for its superior resistance to chloride pitting, crevice corrosion, and the harsh chemical environments encountered during repeated CIP/SIP operations. The BA (Bright Annealed) finish delivers a smooth, non-reactive surface that minimizes microbial adhesion and facilitates thorough cleaning and sterilization.
- Corrosion Resistance: Exceptional resistance to acidic and alkaline cleaning agents (NaOH, HNO₃, H₂O₂) used during CIP cycles, as well as steam at elevated temperatures during SIP.
- Thermal Shock Resistance: Engineered to endure repeated thermal cycling between ambient temperature and sterilization temperatures (up to 134°C) without cracking, distortion, or loss of surface finish.
- Hygienic Surface: Electropolished to a surface roughness of Ra ≤ 0.8 μm (32 μin), compliant with FDA and EU GMP requirements for product-contact surfaces.
- Mechanical Durability: Low carbon content (≤ 0.03% C) prevents sensitization and intergranular corrosion during welding and high-temperature exposure.
- Non-reactivity: Biocompatible and non-leaching, ensuring no contamination of cell culture media or biological products.
Specifications
| Parameter | Specification |
|---|---|
| Material Grade | ASTM A270 316L / EN 1.4404 (00Cr17Ni14Mo2) |
| Surface Finish | BA (Bright Annealed) / Electropolished |
| Surface Roughness | Ra ≤ 0.8 μm (32 μin) |
| Tube Form | Coil (Continuous Coiled Length) |
| Outer Diameter Range | 6.0 – 38.0 mm (0.24" – 1.50") |
| Wall Thickness | 0.5 – 2.0 mm (0.020" – 0.079") |
| Coil Diameter | 150 – 600 mm (5.9" – 23.6") |
| Operating Temperature | 30 – 37°C (86 – 99°F) [Process]; up to 134°C (273°F) [SIP] |
| CIP/SIP Compatibility | Full compatibility — withstands repeated cycles without surface degradation |
| Welding | Orbital TIG welded; welds pass visual and radiographic inspection |
| Standards Compliance | 3-A Sanitary Standards, FDA 21 CFR Part 117, EU GMP Annex 1 |
| Traceability | Full material traceability with mill certificates (EN 10204 3.1) |
Manufacturing Process
- Raw Material Selection: Virgin 316L stainless steel seamless tube stock sourced from certified mills with full chemical and mechanical property verification.
- Cutting & Forming: Precision coil forming using CNC-controlled equipment to maintain dimensional accuracy and uniform curvature throughout the coil length.
- Orbital TIG Welding: Internal and external orbital welding for all joints, with argon gas backing to ensure clean, penetration-free welds suitable for sanitary service.
- Passivation: Acid pickling and passivation to remove surface contaminants and establish a protective chromium oxide layer.
- Electropolishing / BA Finishing: Electrochemical polishing to achieve Ra ≤ 0.8 μm surface roughness, removing micro-scratches, decarburized layers, and embedded particulates.
- Final Cleaning & Inspection: Ultra-pure water rinse, particle count verification, and 100% visual inspection under controlled lighting conditions.
- Packaging: Delivered in protective coil packaging with moisture barriers to prevent surface contamination prior to installation.
Applications
This 316L BA coil tube is specifically designed for the following biopharmaceutical and process applications:
- Fermentation Tank Jackets: Temperature regulation of bioreactor and fermentation vessel media within the critical 30–37°C range for cell culture, microbial fermentation, and protein production.
- Internal Coil Heaters/Coolers: Immersed coil configurations within stainless steel vessels for rapid heat transfer during batch processing.
- Whey Protein & Dairy Processing: Heat exchange in CIP-compatible dairy and food-grade processing equipment.
- Vaccine Manufacturing: Upstream processing equipment requiring repeated sterile cycling.
- Antibiotic & Enzyme Production: Large-scale fermentation systems subject to frequent cleaning and sterilization protocols.
Quality Certifications & Compliance
- ISO 9001:2015 — Quality Management System certification
- ISO 14001:2015 — Environmental Management System
- EN 10204 Type 3.1 — Mill test certificates with full chemical and mechanical analysis
- 3-A Sanitary Standards — Compliant with sanitary design principles for food and pharmaceutical processing
- FDA 21 CFR Part 117 — Compliance with U.S. sanitary equipment regulations
- EU GMP Annex 1 — Aligned with European Commission Good Manufacturing Practice guidelines for sterile products
- ASME BPE — Bioprocessing Equipment standard compliance
Unique Selling Points
Engineered for the Most Demanding Biopharmaceutical Environments
- Superior Thermal Shock Endurance: Unlike standard-grade tubing, this coil tube is specifically validated for repeated thermal cycling between 30–37°C process temperatures and 134°C SIP sterilization without cracking, distortion, or surface degradation — extending service life and reducing unplanned downtime.
- Consistent Ultra-Low Roughness: Guaranteed Ra ≤ 0.8 μm across the entire coil length, ensuring reliable CIP/SIP performance and minimizing biofilm formation risk.
- Full Traceability: Every coil is accompanied by complete material traceability documentation from mill to final product, supporting regulatory audits and quality assurance requirements.
- Custom Coiling Configuration: Available in multiple coil diameters and tube sizes to match specific bioreactor geometry and heat transfer requirements.
- Proven CIP/SIP Compatibility: Demonstrated performance with all common sanitizing agents (NaOH, HNO₃, H₂O₂, steam) without surface attack or chromium depletion.