In order to meet the Biologics License Application (BLA) requirements and maintain compliance a program was established for one of our customers with regard to insulin production, which included process optimizations in a wide variety of manufacturing stages and manufacturing processes on several production lines.
In advance various measures were identified by the customer, presented to the authorities, and confirmed with corresponding timelines.
rantronik was commissioned to manage the implementation of product solution filtration and raw material and media feed systems as project manager for several production lines.
A draft of the required filter concept was revised once again as a guideline in order to protect and close the manufacturing process at certain process limits.
As a result implementation concepts for the gas and liquid filters were developed, discussed in the individual teams and the proposed final solutions were presented to the operations managers and jointly approved. Internal and external stakeholders were integrated into the respective project phases and the tasks were coordinated.
In addition to the duties as project manager, rantronik drew up a detailed project plan with corresponding resource planning for the shutdown implementation, which was integrated into the overarching global project plans.
Do you have any questions or BLA issues or even an urgent need for action? Please get in touch with us. We will be happy to assist you.