Outline of Microbial Biotechnology Plant Construction Process

Outline of Microbial Biotechnology Plant Construction Process

by Micro-Giant BioEngeering 2008.07.28

  1. Decide on production projects and annual yield.
  2. Fermentation flow chart planning - Manufacturing Process (P&ID)
  3. Estimated investment budget (Production revise budget refer to ROI and rate of return)
  4. Market analysis – price, competitors, marketing (channels)
  5. Provisional price – consider manufacturing costs (including raw materials, processing costs, energy consumption calculations, labor cost, equipment depreciation and amortization...) and market expected value.
  6. Plant selection (consider raw materials, transportation of products, man power, environmental impact assessment, wind direction, electricity, water supply)
  7. Plant and production line planning (depend on annual output expansion in the future 3~5 years and the reference market demand to analyze), pay attention to personnel, logistics lines, and prevent cross infection.
  8. Strain acquisition: strain source, strain preservation, strain improvement (strain screening, domesticated strain, and purification) to prevent strain variation, aging and inactivation.
  9. Production process staff arrangement: Production process personnel organization (laboratory RD, production operator, fermentation engineer and technical engineer) and regulations management methods.
  10. Marketing sales arrangement: sales, distributors, sales channel, and establishment of marketing networks.
  11. Administrative, accounting and management staff arrangements.
  12. Laboratory planning (with R&D, production process improvement and QC- qualitative and quantitative analysis of product activity or strain mass)
  13. Biotechnology plant raw material pretreatment (medium formulation) area and equipment.
  14. Strain scale up culture (fermentation) area and equipment.
  15. Back-end process (purification, separation, drying, concentration, abstraction... and sub-packaging) area and equipment.
  16. Central monitoring room.
  17. Storage equipment (including raw materials, semi-finished products, finished products and packaging materials)
  18. Utilities (electricity, process water - city water: soft water or pure water, production process equipment water – chilled water or room temperature water, steam, compressed air, special gases ex.O2, CO2, N, NH3)
  19. Exhaust gas and liquid treatment (including production process waste).
  20. Consideration of recycling or recycling of energy consumption in the production process.
  21. Production government subsidies and tax credit of investment.
  22. Product certification (FDA, GMP, cGMP...).

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