Device built-in

Cytiva 200L Stainless Steel Mixing Vessel Technical Overview

Core Configuration
This 200L mixing vessel is constructed with 316L electropolished stainless steel, featuring an internal surface roughness of Ra≤0.6μm compliant with ASME BPE standards. Equipped with a three-blade inclined impeller (50-1000 rpm adjustable speed) and PTFE mechanical seal system to ensure aseptic operation. The double-jacketed design enables precise temperature control from -20°C to 150°C, with pressure tolerance ranging from full vacuum to 3 bar.

Technological Innovations

1. Intelligent Mixing System:
   • Torque monitoring function for real-time viscosity measurement
   • Switchable laminar/turbulent mixing modes
2. Aseptic Assurance Design:
   • Integrated CIP rotating spray ball (≥95% coverage)
   • All connections use Tri-clamp fittings
3. Digital Management:
   • Optional electronic batch record system
   • Complies with FDA 21 CFR Part 11 data integrity requirements

Applications

• Biopharmaceuticals: Cell culture media preparation (mixing uniformity CV≤5%)
• Vaccine Production: Adjuvant emulsification process (±0.5℃ temp control)
• Gene Therapy: Viral vector buffer preparation

Quality Control

• Complete 3Q validation documentation (DQ/IQ/OQ)
• Material certification included (EN 10204 3.1)
• Factory helium leak testing (≤1×10^-6 mbar·L/s)

Service Support

• Standard delivery lead time: 12-16 weeks
• Optional load cells (±0.5%FS accuracy)
• SIP/CIP validation services available

(Note: Base model priced at ¥180,000-250,000. Final configuration depends on process requirements)

Maintenance Guidelines

• Recommend mechanical seal lubrication every 6 months
• Perform 0.5-1.0 bar pressure integrity testing
• Avoid prolonged exposure to extreme pH conditions (<2 or >12)

Optional Upgrades

• Sterile vent filters with pressure monitoring
• Multi-probe PAT integration package
• GMP-compliant automation upgrade kit

For validation protocols or technical consultation, contact Cytiva application engineers.