plus10 Success Stories

Pharma- and Medtech

GMP & FDA compliant optimization tools

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.

Benefits of Shannon® for Pharma & MedTech

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

Success Story: Shannon® at SCHOTT

Increasing manufacturing line efficiency with Shannon®

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

  • Identification of technical influencing factors regarding individual scrap rate and modelling of counter-actions
  • Technical setup, initialization and brief instruction how to interact with Shannon® done by plus10 onboarding team
  • Productivity already increased during pilot test weeks by 6 % points and reduction of mean variation of productivity during 24/7 operations
  • Technical expert knowledge for problem-solving in case of breakdowns 24/7
  • Quantitative transparency in technical line behaviour, errors, and solutions during normal operations supports conceptional optimizations of new and existing manufacturing lines
polymer syringe
©SCHOTT AG, SCHOTT TOPPAC® polymer syringes
Success Story: Shannon® at Haselmeier

Data-driven production optimization of automated assembly lines for medical self-injection pens revealing up to 10 % OEE increase

Portrait of a man

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).

  • DataCollector for high frequency and synchronized data infrastructure taking several Schneider Electric PacDrive PLC into account
  • Shannon® for automated root-cause analysis of all losses for each short-stop or disturbance during operation
  • Transparency of line behaviour and allocation of loss reasons to each individual downtime or short-stop
  • Quantified and prioritized action list for technical optimization of the assembly line
  • Trend analysis of mean-time-to-repair and mean-time-between-failure for each individual root-cause

Benefits of Darwin for Pharma & MedTech

  • Increase in output per time per machine by reducing the cycle time respecting the validated process in terms of GMP/FDA
  • Reduction of throughput times
  • Identification of performance potential regarding cycle time
  • Early warning system before breakdowns happen