Biotechnology plant planning and validation
Biotechnology plant planning
- User requirement specification
- Process Flow Diagram ( Including equipment planning from upstream to downstream )
- Equipment budget
- Block diagram of equipment and support system
- Plant area usage map
- Equipment and facilities procurement entry schedule control table
Raw material processing, microorganism/cell culture system, post-processing system
- Function requirement specification
- Equipment layout 2D, 3D diagram
- Equipment load table, basic diagram
Support System/Utilities
- Utility demand calculation sheet
- Utility specification table (boiler, air compressor, chiller, process water, special gas, exhaust, and drainage)
- Public facilities layout plan
- Piping and Instrumentation Diagram
- 3D configuration drawing of the whole plant supply pipeline of public facilities
- Operating frame 2D, 3D diagram
Power Systems
- Equipment power specification table
- Power sub-box configuration diagram
Central Supervisory SCADA system
- Central supervisory block control system diagram
- Central supervisory specification request
Validation document plan
- Design Qualification Protocol
- Factory Acceptance Test
- Site Acceptance Test
- Installation Qualification Protocol
- Operation Qualification Protocol
