1. Breakthroughs in the New Standard
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Sterilization Level:
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Dual sterilization (gamma + EO) achieving 10⁻⁶ SAL (Sterility Assurance Level)
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Complies with FDA 21 CFR 880.6860 for medical devices
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Material Innovations:
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0.1μm ultra-fine fibers + nano-silver coating (antibacterial rate >99.99%)
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Anti-static carbon fiber weave (surface resistance 10⁴-10⁶Ω)
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2. Performance Comparison
| Parameter | Sterile Pre-Wetted Wipes | Traditional Wipes |
|---|---|---|
| Cleanliness | ISO Class 3 | ISO Class 5 |
| Microbial Control | Sterile (SAL 10⁻⁶) | Clean (SAL 10⁻³) |
| Particle Residue | <5 particles/m³ (≥0.3μm) | <100 particles/m³ |
| Static Control | Active ion neutralization | Passive anti-static |
3. 4-Step Gold Standard Protocol
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Environmental Verification:
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Pre-use settle plate test (<1 CFU/plate·4h)
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Opening Procedure:
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Sterile tear-notch + vacuum extraction
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Wiping Technique:
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3-zone overlap method (30±5% overlap)
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≥5 sec contact time per 100cm²
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Result Verification:
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ATP testing <5 RLU
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4. Industry Applications
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Pharmaceutical Aseptic Filling:
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Grade A cleanroom surface disinfection
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Eliminates contamination risks of traditional spray-and-wipe
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Semiconductor Manufacturing:
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5nm lithography equipment maintenance
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Prevents electrostatic discharge damage
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5. Certification Framework
✅ International Standards:
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ISO 13485 (Medical Device QMS)
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USP<1072> (Aseptic Processing)
✅ National Standards: -
GMP Annex 1 Sterile Products
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GB/T 32610-2016 (Particle Filtration Reference)