Fully automated production lines e.g. for pharmaceutical primary & secondary packaging as well as stand-alone machines like injection molding machines are commonly used in pharmaceutical and medical equipment production for instance for 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 operational shopfloor assistance, provides situational problem-solving suggestions for the employees at an automated production line. The tool thus forms a continuously operating optimization control loop based on high-frequency PLC data.
Shannon® makes expert knowledge explicitly available to the entire staff 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
„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).
„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 often perform differently over time at the same or at different factories.
Darwin, the Machine Performance Finder, offers several intelligent functions to identify concrete optimization potentials of an automated production line during operation. In this way, it significantly increases the performance level of the machines.
The Machine Benchmark learns a virtual ideal process on the basis of control data from several machines, compares this with the processes of the real machines and provides a target value for the fastest possible production process. Based on this, Darwin continuously generates technical recommendations for reducing the cycle time.
This also provides maintenance with an early warning system at the function or component level to prevent unplanned machine failures and to always operate each machine at its optimum.