1. Mixing Production System Design

Analysis & Planning Stage

• Production requirements identification: product type (liquid, semisolid, etc.), batch capacity, viscosity, and desired homogeneity

• Regulatory standards: design must comply with CPOB, GMP, FDA, and EU Guidelines

• Process integration: mixing, heating, cooling, and automation control systems

Key Design Elements

1. Mixing Tank

   • Material: Stainless Steel SS316L with electropolished surface to prevent contamination

   • Jacketed tank design for heating and cooling processes

   • Agitator/impeller selection based on process requirements (anchor, propeller, or homogenizer type)

2. Piping & Valve System

   • Sanitary piping design with orbital welding and clamp connections

   • CIP/SIP (Cleaning/Sterilization In Place) system for automated cleaning and sterilization

3. Automation & Instrumentation

   • SCADA/PLC systems for controlling mixing speed, temperature, and process timing

   • Sensors for temperature, pressure, and flow rate for real-time monitoring

4. Safety & Validation

   • Interlock systems to prevent operational errors

   • Documentation including URS, DQ, IQ, OQ, PQ for system validation

2. Mixing System Fabrication & Assembly

Preparation & Fabrication

• Tank fabrication according to design in workshop: cutting, welding, and surface finishing

• Fabrication of skid frame for easier transportation and on-site installation

• Pre-assembly of pumps, piping, and valves in workshop before delivery

Automation Integration

• Installation of control panels, PLC, and HMI in workshop

• Integration with sensors and actuators to simplify on-site installation

3. On-Site Installation

Mechanical Installation

• Placement of mixing tank in production area according to layout design

• Installation of product transfer piping, CIP/SIP piping, and utility systems (steam, chilled water, compressed air)

Electrical & Instrumentation Installation

• Connection of control panels to sensors, motors, and actuators

• Integration with SCADA/BMS for production process monitoring

Utility Connections

• Connection to water, steam, electricity, and compressed air supply systems

• Drainage system installation for cleaning wastewater discharge

4. System Testing & Qualification

• Installation Qualification (IQ): verification of installation according to design

• Operational Qualification (OQ): testing mixing operations (speed, temperature, pressure

• Performance Qualification (PQ): validating actual production performance to ensure product quality compliance

• CIP/SIP Validation: testing automated cleaning system performance

5. Standards & Regulations

• CPOB/GMP: Pharmaceutical facility requirements

• ASME BPEASME BPE: Bioprocessing equipment and sanitary piping design standards

• ISO 9001 & ISO 13485 untuk sistem manajemen mutu.