Product Description

Biopharmaceutical BA tubes are manufactured with stringent control over surface cleanliness, dimensional accuracy, and material integrity. The bright annealing process is carried out in a protective atmosphere (high-purity hydrogen or hydrogen-nitrogen mixture), preventing oxidation and eliminating the need for acid pickling, which avoids the risk of hydrogen embrittlement. The resulting surface is mirror-like, smooth, and free of directional texture, making it the gold standard for high-purity systems in the biopharmaceutical industry.

Biopharmaceutical BA Tube Applications

Biopharmaceutical BA tubes are widely used in the pharmaceutical and biotechnology industries where fluid purity, surface cleanliness, and regulatory compliance are paramount. Key application areas include:
·Water for Injection (WFI) Systems — Distribution of sterile water for pharmaceutical formulations, meeting cGMP and FDA requirements
·Pure Steam Systems — Clean steam generation and distribution for sterilization processes
·Vaccine and Biologics Production — Sterile fluid transfer systems for vaccines, monoclonal antibodies, and other biological products
·Buffer and Media Preparation — Transfer of buffers, cell culture media, and other process fluids
·Clean-in-Place (CIP) Systems — Piping for CIP and sterilization-in-place (SIP) systems
·High-Purity Gas Distribution — Transport of nitrogen, argon, and other process gases in洁净 environments
·Laboratory and Analytical Instrumentation — Sample flow paths for chromatography, mass spectrometry, and other precision instruments
·Cleanroom Utility Piping — Ultra-pure water (UPW), process air, and other utility systems in pharmaceutical purity facilities
The biopharmaceutical industry increasingly relies on BA tubes for critical fluid systems, as the smooth inner surface (Ra ≤ 0.4 μm) effectively reduces fluid resistance, minimizes particle retention, and prevents microbial adhesion and biofilm formation.

Product Detail

Parameter	Value
Product Name	Biopharmaceutical Bright Annealing Tube
Outside Diameter	3/16" ~ 2" (4.76mm ~ 50.8mm)
Wall Thickness	0.028" ~ 0.188" (0.71mm ~ 4.78mm)
Manufacturing Standard	ASTM A213, ASTM A269
Forming Process	Cold Rolling & Cold Drawing
Standard Length	6 meters / each, or customized
OD Tolerance	±0.1mm (3/16"~1 1/2"), ±0.2mm (1 1/2"~3 1/2")
WT Tolerance	±8% (3/16"~1 1/2"), Nominal (1 1/2"~3 1/2")

Material Grade

Grade	UNS	ASTM	EN
304L	S30403	304L	1.4307
316L	S31603	316L	1.4404
316Ti	S31635	316Ti	1.4571

Notes

1.316L (UNS S31603 / EN 1.4404) is the most widely recommended material for biopharmaceutical applications due to its superior corrosion resistance, low carbon content (which minimizes sensitization during welding), and compatibility with pharmaceutical-grade surface finishes.
2.For biopharmaceutical applications, materials are typically specified to meet ASME BPE (Bioprocessing Equipment) standards, which define stringent requirements for material composition, surface finish, and cleanliness.
3.Ultra-low carbon grades are preferred to maintain corrosion resistance after welding, which is critical for maintaining system integrity in sterile fluid transfer applications.

Production Standard

Standard	Description
ASTM A213	Seamless Ferritic and Austenitic Alloy-Steel Boiler, Superheater, and Heat-Exchanger Tubes
ASTM A269	Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
ASTM A270	Seamless and Welded Austenitic Stainless Steel Sanitary Tubing
ASME BPE	Bioprocessing Equipment Standard — Recommended for tubing systems, system components, and equipment for bioprocessing
3A Sanitary Standards	Sanitary standards for dairy and food processing equipment

Pharmaceutical quality may be requested as a supplementary requirement to ASTM A270

Dimension Tolerance

Outside Diameter (OD)	Tolerance OD (mm)	Tolerance WT (%)
3/16" ~ 1 1/2"	±0.1	±8
1 1/2" ~ 3 1/2"	±0.2

Nominal Length: 6 meters / each, or customized.
If higher outside diameter tolerance is required, welcome to contact us. Roughness BA Roughness:
✓  Outer: Ra ≤ 0.4 ~ 0.8 µm
✓  Inner: Ra ≤ 0.4 ~ 0.8 µm
We commonly provide around 0.8 µm. Also can be customized.

Biopharmaceutical Note: For critical pharmaceutical applications such as WFI and product-contact systems, inner surface roughness of Ra ≤ 0.4 μm is widely recommended to minimize microbial adhesion and facilitate cleaning. Higher-grade biopharmaceutical applications may require Ra ≤ 0.38 μm (SF4) or better to meet ASME BPE standards

Maximum Allowable Working Pressure Rating (316L Seamless) Unit: Psi

OD \ WT	0.010	0.012	0.014	0.016	0.020	0.028	0.035	0.049	0.065	0.083	0.095	0.109	0.120	0.134	0.156	0.188
1/16	5600	6900	8200	9500	12100	16800
1/8						8600	10900	10300
3/16						5500	7000	7500
1/4						4000	5100		10300
5/16								4100	5900	8100	6700
3/8								3300	4800	6600	5000
1/2								2600	3700	5100	4200	5800
5/8								3000	4000	5200	6100
3/4								2400	3300	4300	5000	4900
7/8								2100	2800	3600	4200
1										2400	3200	3700	4700	4100	4900	4500
1-1/4										2500	2900	3300	3700	3400	4000
1-1/2										2400	2400	3000	3000
2												2000	2200	2500	2900	3200

Final Inspection

Surface Quality
OD & WT, Length, Straightness, roughness BA and endoscopy.
Chemical Composition
Spectrum analysis.
Mechanical Test
Tensile，Yield， Elongation (%，)Hardness (HRB)
NDT (Non-Destructive Testing)
ET (Eddy Current testing).
PMI (Positive Material Identification)
Direct-reading spectrometer.
Marking and Color Coding
Marking and color coding available if required.
Biopharmaceutical Note: For pharmaceutical applications, additional inspections such as surface cleanliness verification, passivation validation, and documentation of material traceability (MTR) can be provided to support regulatory compliance and GMP requirements

Packing

All tubes are protected with caps at both ends + PE bag + wooden case.
1. End Capping — Both ends of each tube are protected with caps.
2. PE Bag — Tubes are bagged in polyethylene for cleanliness.
3. Wooden Case — Finally placed in wooden cases for maximum protection during shipment.

Biopharmaceutical Note: For purity applications, additional packaging options such as cleanroom-grade double-bagging, nitrogen purging, and particle-count certified packaging are available upon request to meet pharmaceutical and semiconductor industry requirements