The overall task of this second bachelor thesis was to design a fermentation site to produce GFP (Green Fluorescence Protein) by Escherichia coli as teamwork. This work package refers to premises. Therefore a room plan was developed and different clean room grades (B, C) were defined. Moreover several quality-related documents (SOP Standard Operating Procedure, form sheets) were created to enable an easy and sufficient room cleaning and monitoring. Furthermore parts of this work package were the calculation of an alternative production strategy (Chemostat) and the description of the fourth chapter “premises and equipment”, which is an element of the Site Master File. |