Premium 304 2b Electropolished Stainless Steel Sheet for Pharma

Product Description

304 2B Electropolished Mirror Stainless Steel Sheet

Pharmaceutical-Grade Surface Perfection for Critical Bioprocessing Vessels

 

Technology Essence

Precision electropolished 304 stainless steel sheets deliver Ra≤0.1μm mirror finish - 10X smoother than standard 2B surfaces - eliminating microbial harborage sites while achieving 0.01μg/cm² extractables, exceeding USP <661.1> and ASME BPE requirements for biopharma applications.

 

Certifications & Compliance

Standard	Certification
Material	ASTM A240/A480 / EN 10088-2
Surface Finish	ASME BPE-2022 SF-1 / ISO 13485
Cleanability	EHEDG Doc.8 Class 1 / 3-A Sanitary Standard
Bio-Compatibility	USP Class VI / ISO 10993-5

 

Technical Specifications

Parameter	Value
Base Material	304 (UNS S30400)
Thickness	0.8mm (±0.02mm)
Sheet Dimensions	1219×2438mm (Customizable)
Surface Roughness	Ra≤0.1μm (ISO 4287)
Microhardness	HV 155-175 (ISO 6507)
Passivation	ASTM A967 Citric Acid Method
Flatness	≤0.3mm/m (EN 10029 Class A)

 

Core Performance Advantages

1. Unmatched Cleanability

• Bacterial Adhesion Reduction: 98% less E.coli adhesion vs. Ra 0.8μm surface (per ASTM E2149)

• CIP Efficiency: 90% chemical reduction during clean-in-place cycles

2. Corrosion Defense

• Pitting Resistance: CPT >35°C (ASTM G150) in 6% FeCl3

• Intergranular Corrosion: Passes ASTM A262 Practice E (Streicher test)

3. Regulatory Compliance

• Extractables: <0.01μg/cm2 total organic carbon (TOC)

• Leachables: ND for Cr/Ni/Mo (ICP-MS detection limit 0.1ppb)

 

Surface Performance Data

Test Method	Standard 2B	Electropolished	Improvement
Ra (μm)	0.4-0.6	≤0.1	5X smoother
Contact Angle	85°	25°	Superhydrophilic
Gloss Level (GU)	220	950	4.3X brighter
Passive Layer	2.1nm	5.3nm	2.5X thicker

 

Pharma Application Validation

Project: 20,000L Monoclonal Antibody Fermenter (BioPharmX Ltd.)

Parameter	Result
Surface Treatment	Electropolished + Passivated
Sterilization	200+ SIP cycles : 121°C
Bioburden Control	0 CFU/100cm2 (EM monitoring)
Maintenance	Zero surface-related deviations in 3 years

 

Manufacturing Process Flow

1. Base Material: Cold-rolled 2B finish (Ra 0.4μm)

2. Electropolishing:

   • Electrolyte: H2SO4/H3PO4 : 65°C

   • Current Density: 25 A/dm2 × 12min

3. Passivation: Citric acid : 70°C (ASTM A967)

4. QA Inspection:

   • White light interferometry (ISO 25178)

   • Ferroxyl test for passive layer integrity

 

Economic Value for Biopharma

Benefit	Impact
Validation Cost	40% reduction (pre-validated surface)
Sterilization Time	30% shorter SIP cycles
Product Yield	0.5% increase (reduced contamination)
Lifecycle Cost	$18/m2/year vs. $42 for mechanical polish

 

Why Pharma Engineers Specify This Material?

 Biofilm Prevention: Eliminates micro-crevices where bacteria proliferate
 Extractables Control: Meets ICH Q3D elemental impurities limits
 Validation Ready: Full material traceability from melt to final polish
 Capital Efficiency: Saves $250k in qualification costs per 10,000L tank

 

Technical Support Services

• Welding Protocols: Orbital TIG procedures for Ra≤0.15μm weld seams

• Cleanability Validation: Biofilm challenge testing per ASTM E2871

• Custom Certification: 3.2 Material Certificate per EN 10204

 

Request Documentation:
1. BPE SF-1 Compliance Report 
2. USP <661.1> Extractables Study

3. Biofilm Test Data

4. Electropolishing Validation Package

304 Electropolished Mirror Finish: Where surface science meets sterile assurance.

 

Industry Adoption:

• Genentech: Buffer preparation tanks

• Pfizer: mRNA drug substance vessels

• Lonza: Cell culture bioreactors

 

Comparative Surface Performance

Parameter	Electropolished (Ra≤0.1μm)	Mechanically Polished (Ra 0.3μm)	Bead Blasted (Ra 1.2μm)
Microbial Adhesion	+++++	+++	+
CIP Efficiency	+++++	++++	++
Corrosion Resistance	++++	+++	++
Initial Cost	++	+++

OUR TEAM

FAQ
1.Q: How long is your delivery time?
A: Within 7-15 days after receiving the deposit or L/C at sight. Longer lead time will be required for special designed products.
2.Q: Do you provide samples ? is it free or extra charged?
A:Surely, product sample is complimentary but the delivery fee will be covered by our customers.
3.Q:What's your payment terms?
A:Our Payment trems will be
(1) 100% T/T
(2) 30% in advance,others before shipment.
4. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;
5.what can you buy from us?
Excellent quality steel at competitive prices