GMP Cleanroom Pre-Wetted Wipes:

1. Core Product Features

• Sterility Assurance:

  • Dual sterilization (25kGy gamma + EO gas) meeting 10⁻⁶ SAL

  • Endotoxin levels <0.25EU/mL (USP<85> compliant)

• Material Innovation:

  • 0.2μm ultra-fine fibers (ISO Class 3 cleanliness)

  • Nano-silver coating (antibacterial rate >99.9%)

2. GMP Compliance Design

✅ Packaging System:

• Triple sterile barrier (PET/AL/PE laminate)

• Nitrogen flushed + vacuum sealed
  ✅ Quality Control:

• Bioburden testing (<10CFU/100cm² per batch)

• Particle release testing (<5 particles/m³ ≥0.5μm)

3. Biopharma Applications

• Grade A Zones:

  • Aseptic filling line surfaces

  • Isolator interior maintenance

• Grade B Areas:

  • Biosafety cabinet cleaning

  • Lyophilizer chamber treatment

4. 5-Step Standard Protocol

1. Environment Verification:

   • Settle plates (<1CFU/4h)

2. Aseptic Opening:

   • Use dedicated tear-notch tool

3. Wiping Technique:

   • Unidirectional overlap (30±5%)

4. Contact Time:

   • ≥30 seconds for disinfection

5. Validation:

   • ATP testing <5 RLU

5. Competitive Advantages