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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.
5 – 15 % increase of production effectiveness (OEE) in 24/7 operations mode due to reducing downtimes and troubleshooting (MTTR)
10 – 30 % shortening the ramp-up and relocation phase in the global production network
GMP/FDA-compliant documentation of all suggestions and action
Increasing cost efficiency by reducing unit costs and breakdown-related scrap
– 30 % of variation of trouble-shooting nduration in between different shifts
„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".
Michael Feldhaus
Pharmaceutical Systems/Director Technology - SCHOTT Schweiz AG
Significant increase and stabilization of the productivity of a fully automated syringe production line running 24/7
DataCollector for generating a high frequency and synchronized data infrastructure taking all PLC into account
Shannon® for situational recommendations of trouble-shooting actions based on detected root-causes
„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.“
Matthias Meissner
COO Haselmeier GmbH
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).
