Outline of Microbial Biotechnology Plant Construction Process
Outline of Microbial Biotechnology Plant Construction Process
by Micro-Giant BioEngeering 2008.07.28
- Decide on production projects and annual yield.
- Fermentation flow chart planning - Manufacturing Process (P&ID)
- Estimated investment budget (Production revise budget refer to ROI and rate of return)
- Market analysis – price, competitors, marketing (channels)
- Provisional price – consider manufacturing costs (including raw materials, processing costs, energy consumption calculations, labor cost, equipment depreciation and amortization...) and market expected value.
- Plant selection (consider raw materials, transportation of products, man power, environmental impact assessment, wind direction, electricity, water supply)
- 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.
- Strain acquisition: strain source, strain preservation, strain improvement (strain screening, domesticated strain, and purification) to prevent strain variation, aging and inactivation.
- Production process staff arrangement: Production process personnel organization (laboratory RD, production operator, fermentation engineer and technical engineer) and regulations management methods.
- Marketing sales arrangement: sales, distributors, sales channel, and establishment of marketing networks.
- Administrative, accounting and management staff arrangements.
- Laboratory planning (with R&D, production process improvement and QC- qualitative and quantitative analysis of product activity or strain mass)
- Biotechnology plant raw material pretreatment (medium formulation) area and equipment.
- Strain scale up culture (fermentation) area and equipment.
- Back-end process (purification, separation, drying, concentration, abstraction... and sub-packaging) area and equipment.
- Central monitoring room.
- Storage equipment (including raw materials, semi-finished products, finished products and packaging materials)
- 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)
- Exhaust gas and liquid treatment (including production process waste).
- Consideration of recycling or recycling of energy consumption in the production process.
- Production government subsidies and tax credit of investment.
- Product certification (FDA, GMP, cGMP...).
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