Genentech’s Quality and Project Plans defined the procedures, standards, organizations, roles and responsibilities, processes and documentation that would ensure a controlled and traceable development of the automation system.
To create the User Requirements Specification, Genentech formed a multi-departmental, cross-functional team, and chartered it with the design, procurement, installation, startup and qualification of a suite of bioreactors and CIP equipment for the production of Nutropin. The team included in-house engineering expertise in process design, manufacturing science, automation and manufacturing operations, as well as applications engineers from the Foxboro automation group of Invensys, Foxboro, Mass.
The decision was made to automate this manufacturing process completely, from media preparation and bioreactor integrity test, through media addition, bioreactor sterilization, bioreactor inoculation, feed preparation, production, product transfer and bioreactor cleaning.
While moving through the early phases of the GAMP4 process, the team was working under the tacit assumption that it would continue to use separate recipes for each step of the process. As parallel-processing efficiencies became increasingly feasible, however, it also became evident that the entire process could—and probably should—be integrated into a single recipe following the ISA-88 standard.
When an operator schedules and starts the recipe, known as the master recipe, the system creates the control recipe (a working version of the master recipe), acquires all equipment, sterilizes each, puts it in production and monitors it through completion.
As each unit procedure completes, the transfer lines, tanks and bioreactors are cleaned and ready for the next cycle. Each cycle begins with clean equipment and leaves it that way, ready for the next use.