Agenda

The new manufacturing paradigms in life sciences pose considerable challenges to the engineers who have to deal with automation and digitalization. For example, the operational flexibility required in biotech, the modules that make up the production processes in flow chemistry and the inefficiencies caused by the numerous manual operations in cell therapies. But what do these production sectors have in common? They consist of modules specialized in specific functionalities linked together to produce a specific product. Modules produced by different suppliers, often incompatible from a digitization point of view. For some years now, the concept of 'modular production' has been gaining ground, whereby production processes are subdivided into intelligent modules capable of communicating with each other in a standardized manner. These are combined with a software application capable of automatically recognizing the various modules and 'orchestrating' their operation according to a user-defined sequence. We call it “plug & produce”. To support this production concept, a standard called MTP - Module Type Package (VDI/VDE/NAMUR 2658) - has been developed and has proven its worth in recent years. The authors of this contribution are members of the Plug & Produce working group of the ISPE Pharma 4.0 CoP.  The presentation will introduce the advantages of this new approach based on the MTP standard by giving concrete examples of the application of modular automation in the life sciences field, contained within a concept paper that is currently being developed.