COLD STORAGE MANUFACTURING INC.
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XNAIR engineers GMP-grade production cold rooms for pharmaceutical manufacturing, vaccine filling, and cytotoxic drug handling. Our -80°C to +8°C modular cold storage maintains EU Annex 1 particle counts with HEPA-sealed airtight pass-throughs. cGMP-compliant stainless-steel interiors (Ra≤0.5μm) enable sterile vial loading/unloading.

Patented cascade refrigeration sustains ±0.5°C during lyophilization, with N+1 redundancy preventing batch loss. Real-time BMS tracks temperature/humidity/dew point against 21 CFR Part 11 requirements, triggering SMS alerts for excursions. Post-installation, we execute raw data IQ/OQ/PQ validation with thermal mapping. Lifetime support includes 4-hour emergency response for critical processes.

Production Process

  • Design:EU GMP Annex 1 Certified
  • Temp Control:±0.5°C Stability
  • Cleanroom:Class C Integration
  • Materials:cGMP-compliant SS316
  • Cooling:Redundant Cascade Systems

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