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
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