Premium 304 2b Electropolished Stainless Steel Sheet for Pharma
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| Customization: | Available |
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| Standard: | ASTM, AISI, GB, JIS, DIN |
| Certification: | ISO, RoHS, IBR |
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Basic Info.
- Model NO.
- SS sheet-KF0718
- Technique
- Cold Rolled
- Surface Treatment
- Bright
- Surface
- Ba/2b/No.4/8K/Hl
- Transport Package
- Standard Export Package
- Trademark
- MESCO
- Origin
- China(Mainland)
- Production Capacity
- 10000tons/Year
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
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Bacterial Adhesion Reduction: 98% less E.coli adhesion vs. Ra 0.8μm surface (per ASTM E2149)
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CIP Efficiency: 90% chemical reduction during clean-in-place cycles
2. Corrosion Defense
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Pitting Resistance: CPT >35°C (ASTM G150) in 6% FeCl3
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Intergranular Corrosion: Passes ASTM A262 Practice E (Streicher test)
3. Regulatory Compliance
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Extractables: <0.01μg/cm2 total organic carbon (TOC)
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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
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Base Material: Cold-rolled 2B finish (Ra 0.4μm)
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Electropolishing:
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Electrolyte: H2SO4/H3PO4 : 65°C
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Current Density: 25 A/dm2 × 12min
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Passivation: Citric acid : 70°C (ASTM A967)
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QA Inspection:
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White light interferometry (ISO 25178)
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Ferroxyl test for passive layer integrity
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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
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Welding Protocols: Orbital TIG procedures for Ra≤0.15μm weld seams
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Cleanability Validation: Biofilm challenge testing per ASTM E2871
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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:
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Genentech: Buffer preparation tanks
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Pfizer: mRNA drug substance vessels
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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 | ++ | +++ |
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
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