Monitoring System and Method for Biopharmaceutical Products

A system for monitoring a set-up for manufacture and/or setting up for manufacture of a biopharmaceutical product, said system comprising:

• a manufacture system for manufacturing the biopharmaceutical product,
• at least one image capture device arranged to capture images of a scene comprising the manufacture system, and
• a processing element connected to said at least one image capture device and arranged to process images captured by said at least one image capture device to track operator interactions and/or a result of operator interactions within the scene,
• wherein the processing element is further arranged to:
• determine facilities for the manufacture is ready for the step-up for manufacture and/or the setting up for manufacture, wherein the facilities for the manufacture comprise the at least one external device,
• obtain information relating to the at least one external device connected to the manufacturer system, wherein the at least one external device comprises at least one single-use consumable,
• compare at least part of the obtained information relating to the at least one external device to characteristics of the external device defined in a predetermined workflow process scheme, and
• determine whether the pre-set criterion set by the predetermined workflow process scheme relating to the characteristics of the at least one external device connected to the manufacture device is fulfilled.