plus10 Success Stories

Pharma & 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 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® for Pharma & MedTech

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).

Benefits of Shannon® for Pharma & MedTech

  • 5-15% increase of production effectiveness (OEE = Overall Equipment Effectiveness) in 24/7 operations mode due to reducing breakdowns and corresponding downtimes related to breakdowns, short stops or frequent turbulences e.g. empty cycles (MTTR = Mean time to repair)
  • Increasing cost efficiency by reducing unit costs and breakdown-related scrap
  • 10-30% shortening the ramp-up and relocation phase in the global production network
  • -30% of variation of trouble-shooting duration in between different shifts
  • GMP/FDA-compliant documentation of all suggestions and actions
screen of a smartphone with shannon app showing the solution to recalibrate spring insertion
Success Story: Shannon® at SCHOTT

Increasing manufacturing line efficiency with Shannon®

Target

Significant increase and stabilization of the productivity of a fully automated syringe production line running 24/7

Solution

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

Benefits
  • 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 situationally available 24/7 and expandable
  • 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

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

Success Story: Shannon® at Haselmeier

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

Target

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).

A range of self injection pens
© Haselmeier GmbH
Solution

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

Benefits
  • 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

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

Portrait of a man

Darwin for Pharma & MedTech

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.

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

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