STERILE MANUFACTURING VESSEL

A hygienic, GMP-compliant SS316L vessel designed for sterile preparation, holding, and transfer of liquid formulations in sterile pharmaceutical manufacturing. Available in jacketed or non-jacketed, with options for mixing, heating, cooling, and CIP/SIP integration.

Technical Specifications:

  • Capacity Range: [Customize – e.g., 50 to 5000 Litres]
  • Material of Construction: SS316L (Product Contact)
  • Finish: Internal Electro-polished (Ra ≤ 0.4 µm), External Matt Finish
  • Temperature Range: Up to 121°C (SIP capable)

🔩 Key Components:

  • Top or Bottom Entry Agitator (Magnetic / Mechanical Seal)
  • Jacket / Limpet Coil (for Heating/Cooling with Steam or Chilled Water)
  • Vent Filter Housing (0.2 µm)
  • Load Cells / Level Transmitter (optional)

🧠 Automation & Controls:

  • Optional PLC + HMI Interface
  • Integrated Sensors: Temperature, Pressure, RPM, Level
  • Safety Interlocks for Overpressure / Overtemperature
  • Batch Control (with Recipe Programming – optional)

📋 Documentation & Validation:

  • DQ / IQ / OQ / PQ
  • MOC with EN 10204 3.1 Certificates
  • Surface Finish & Weld Reports
  • GA Drawings / P&ID

📐 Compliance Standards:

  • cGMP | FDA | WHO
  • ASME BPE | ISPE | GAMP 5
  • 3A Sanitary Standards (where applicable)

Suitable for Cleanroom Installation (Grade A/B)