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)