Fully automated production lines e.g. for pharmaceutical primary & secondary packaging as well as stand-alone machines like injection molding machines or assembly cells are commonly used in pharmaceutical and medical equipment production for instance for syringe production, self-injection pens or rapid tests for Covid-19.
Output, Ramp-up or cost-efficiency challenges
A typical efficiency of such kind of production equipment is 55-85 % OEE (Overall equipment effectiveness) facing a long ramp-up period between several months up to two years. In addition GMP/FDA requirements must be fullfilled at all times.
Artificial intelligence (AI) tools from a regulatory affairs point of view (GMP/GAMP, FDA)
All digital solutions that are used in such kind of critical environment must fulfill GMP (good manufacturing practice) standards to the full extent to guarantee a validated production process including data-integrity. Our optimization tools are designed to respect those requirements by all means. Therefore we consider a risk based approach of EU-GMP Annex 11, the practical GAMP 5 guideline as well as computerized system validation (CSV) procedures.
Shannon®, the Real-time Solution Recommender, provides situational problem-solving proposals to reduce breakdowns and short stops of automated production lines. Thus the tool forms a continuously effective optimization loop based on high-frequency data of all machine controllers.
Shannon® makes expert knowledge explicitly available to the entire staff worldwide at the right moment in a mobile app! At the same time it can contribute to GMP/FDA-compliant documentation such as batch records, line clearance checklists and situational standard operating procedures (SOP).
Significant increase and stabilization of the productivity of a fully automated syringe production line running 24/7
for generating a high frequency and synchronized data infrastructure taking all PLC into account
for situational recommendations of trouble-shooting actions based on detected root-causes
„The continuously learning tool Shannon® for the allocation of errors to their technical root causes and the situational generation of solution proposals has already brought us approx. 5% more productivity during the pilot phase on a fully automated syringe production line. In addition, the spread of productivity across all shifts was reduced by more than 30%. The situationally transmitted solution proposals thus show a clear effect".
Pharmaceutical Systems/Director Technology - SCHOTT Schweiz AG
Identification and quantification of root causes of availability and performance loss in a fast-moving and fully automated assembly line producing self-injection pens (Initial OEE: 70%-80%, cycletime below 5 seconds).
for high frequency and synchronized data infrastructure taking several Schneider Electric PacDrive PLC into account
for automated root-cause analysis of all losses for each short-stop or disturbance during operation
„Our aim was to identify the technical potentials to significantly reduce manufacturing costs. Therefore, the results are of great importance to us, as they detect and objectively quantify root causes of all losses.“
COO Haselmeier GmbH
Stand-alone machines e.g. injection moulding machines to produce syringes, valves or components for medical devices often perform differently over time at the same or at different factories.
Darwin, the intelligent machine benchmark, learns a virtual ideal process based on high-frequency PLC data from all connected machines and thus provides a target value how fast each machine could be and how to get there. Based on this, Darwin continuously generates individual recommendations for reducing the cycle time. Maintenance departments are empowered by Darwin to avoid breakdowns before they happen thanks to early warnings.