QUALIFICATION OF A FERMENTATION TECHNOLOGY

Name of the product Structure Molecular Weigh CAS RN - Assay Process type (batch or semi-continuous) Phases of the process (pre-seed, seed, etc., and percentages of inoculum for each phase ) Requirements for microbiological laboratory including thermostatic rooms and flask shakers Potency of the harvest broth (if the process is semi-continuous the potency will be the average) Fermentation cycle time Fermentation down time Volume of harvest broth/fermentation batch Sterilization type (batch or continuous) Basic flow diagram showing the main equipment and all streams (inlet and outlet) Main equipment list showing, for each item, sites, construction material, installed power and other information relevant to the technology valuation and/or to the cost estimate Specific consumption of main raw materials, (kg / kg of activity in the harvest broth) For minor raw and auxiliary materials, total cost /kg of activity of the harvest broth Specification of main raw materials Requirements for feedings Requirements for blending (in case of semi-continuous process) Fermentation air consumption (average and peak) Utilities consumption (average and peak): Steam Compressed air (instruments and other services) Cooling water (amount of heat to be drawn) Chilled water (temperature and heat quantity to be drawn) Brine (temperature and heat quantity to be drawn) Electric power Process control requirements (showing all parameters involved in on-line process control) Off-line process control (showing type and number of specific analysis)