Device built-in

LePure 100L Aseptic Mixing Vessel - Pharmaceutical-Grade Solution Preparation System

The LePure 100L Plastic Mixing Vessel is a compact, high-performance solution preparation unit designed for pharmaceutical, biotech, and fine chemical applications requiring precise, contamination-free liquid processing. This GMP-compliant system combines advanced material science with ergonomic design for laboratory and pilot-scale operations.

Technical Specifications:

• Nominal Capacity: 100 liters (80% working volume)
• Construction: Monolithic rotational-molded polypropylene (USP Class VI) with optional PTFE or PFA lining
• Agitation System:
  • Top-mounted mixer with 50-200 RPM variable speed drive
  • PTFE-coated impeller options (anchor/paddle/turbine)
• Temperature Control:
  • Standard: -20°C to +80°C ambient operation
  • Optional: Jacketed design (-30°C to +120°C)
• Process Connections:
  • (4) 1.5" tri-clamp ports (2 side, 1 top, 1 bottom)
  • Additional 0.5-1" NPT threaded ports available
• Surface Finish: Ra ≤0.4μm electropolished interior
• Compliance: Meets FDA 21 CFR 177.1520, EU 10/2011, USP <88> Class VI

Key Features:

1. Aseptic Design Features:

   • Fully drainable geometry (0° bottom slope)
   • Dead-leg free piping configuration
   • Steam-sterilizable up to 121°C (30 min SIP capability)

2. Advanced Control Options:

   • Integrated load cells (±0.1% accuracy)
   • PLC-based recipe management system
   • 21 CFR Part 11 compliant data logging

3. Mobility & Ergonomics:

   • Stainless steel mobile base (304 or 316L)
   • Height-adjustable stand (800-1200mm)
   • Clear polycarbonate protective shield

Typical Applications:

• Buffer exchange in monoclonal antibody production
• Cell culture media preparation
• Vaccine adjuvant formulation
• High-value API solution preparation

Validation Support:

• DQ/IQ/OQ documentation packages
• Material certificates (3.1/3.2)
• Extractables & leachables studies available

Note: All wetted materials comply with USP <661> plastic requirements. "LePure" is a registered trademark in major pharmaceutical markets.