A bit of -on line- science in Pharma manufacturing

Transcription

1 A bit of -on line- science in Pharma manufacturing 2012, June 28 th IS Innovation Awards 2011: Communication Kit 1

2 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Breaking walls between Lab and Production Plant WYSIWIG 2.0: What You Simulate Is What You Get Short introduction Business / technical issue: more and more process understanding in order to implement QBD (Quality by Design concept) and to cut production costs are at stake. This requires to quickly experiment new ideas born in the Lab at industrial level. However technical roadblocks are on the way from LAB to Industrial scale: actually there are 2 worlds with different IS equipment and languages, substantially slowing down the process transfer or even collapsing it. Usually simulations done at Lab scale must be transposed to industrial equipment requiring to translate programs into very specific languages and sometimes heavy re-validation tasks. This takes time, money and sometimes makes smart projects never reaching industrial scale or even pilot scale. The solution: a PC profiled to process control area + a skilled simulation tool (SCILAB / INRIA) with real time connection capabilities to industrial equipment above hurdles can be fully overcome. It applies to a wide variety of projects, from process production improvement to energy management optimization. (*) SAWv7 (LPC LAB Process Control), based on Windows 7 and office

3 Binder 1 Disintegrant Paracetamol (powder) Exhaust Air Weighing Granulation 1. Raw materials preparation and loading 2. Granulation 3. Drying 4. Discharge 5. Sieving 6. Mixing 7. Compression 8. Packaging Buffer Packaging Granulation Drying Doliprane (tablets) Compression Compressed Air Water + Binder 2 Process Air Lubricant Glidant Sieving Mixing Doliprane (granules) No reliable nor affordable on- line moisture measurement

4 Process modeling: Mass balance Principle: water mass conserva2on Assump2ons: Pulverized water used to wet solid Vaporized water 100% to outlet air No water losses Partial mass flow rates of water in air : 4

5 Process modeling: Heat balance Principle: energy conserva2on Assump2ons: Heat parameters constant during a batch Heat capacity of air such that Cpair = Cpdry,air 5

6 Es2ma2on of solid moisture: 3 models for the Fluid Bed Granulator/Dryer Mass balance: water mass conserva2on Heat balance: energy conserva2on Mollier chart: thermodynamics and equipment efficiency + 1 model for the buffer tank Results Es2ma2on of fluid bed clogging: Increasing of pressure drop over a campaign of produc2on

7 Results: quality of on line estimation better than 0.5% (target) Accuracy better than 0.5%

8 Why is this delivered so late? On the one hand LABs: Powerful computers able to run big models On the other hand PLANT: at industrial equipment level: very poor calculation capacities (PLCs, SCADA) No direct connection with industrial systems (PLC + SCADA) Proofs of concepts remain at lab level

9 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Industrial scale can progress only if R&D and Industrial scale can communicate easily Nevertheless big differences stand in progress way LAB SCALE Concept, model, equations, control strategy As per design and technological specificities: NO TRANFER (Reptiles can not read equations) INDUSTRIAL SCALE Real time oriented Specific systems (SCADA, PLCs) Big Brain Armless Good ideas remain future for ever Big hands Tiny / reptilian brain 9

10 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 The challenge: a big roadblock over the way from Lab to Industrial scale 2 worlds, 2 systems and languages needing permanent translation LAB SCALE INDUSTRIAL SCALE Concept & simulation tool Tuning different Systems and, languages substantial: adpatation Back Industrial / pilot equipment (i.e. Excel, Matlab, translation Validation costs SCADA specific system Quite long time Scilab) to market And forth The TRANSLATION WALL 10

11 IS Global Innovation Awards 2011 WYSIWIG 2.0 What You Simulate Is What You Get THE SOLUTION : how to remove barriers LAB SCALE INDUSTRIAL SCALE Concept & simulation tool Back And forth Industrial / pilot equipmentsca DA specific system (Scilab) Tuning Direct connection between the 2 worlds SAWv7 Bi directionnal transparent pass through PC PLC 11

12 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Application to online estimation of Relative Humidity in Fluid bed Dryers From Lab to Industrial scale on the same machine just a PC as a bridge! SAWv7 Direct monitoring and control of 15% of productivity increase expected (250 k / year), easy deployment across about 200 fluid bed dryers within IA 12

13 Application to Air Handling Unit At plant level in Pharma industry: 70 to 80% of energy = Heating, Ventilation, Air Climatisation Control of Temperature, Air Moisture, differential pressure between areas 13

14 Application to Air Handling Unit Evidence of oscillations in Air Handling Units control Cooling valve Heating valve 14

15 Next potential candidates Lyophilisation Crystallization 15

16 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Paving the way for a better controlled production Before this innovation sophisticated models at lab level requiring changes to be brought to equipment, in complex languages a lot of effort and validation no connection between the two - a "black box" at industrial equipment level where only a final output can be seen (yield, energy consumption...) With WISYWIG Quite a simpler model is proposed on an industrial PC, making the 2 worlds communicating directly in real-time This enables testing with no delay new control / production strategies based on last enhancements from labs Getting actual process data speeds up, via simulation, process model improvement No adaptation / translation not delay, no additional validation effort In the future This innovation is transposable to other sites with similar or other equipment (e.g. freeze-drying, crystallization ) It can be used for training purposes as well This paves the way to the next steps Process Analytical Technologies, as per FDA requirement Self-learning systems that will improve process understanding, then yield, OEE and industrial production costs 16

17 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Competitiveness & Value Creation (or Opportunities for Best PoC / Prototype Dossiers): Because it removes quite a handsome and costly step from concept to production, this solution enables to make quick PoC at pilot or industrial. Nice ideas that so far were not implementable become real via this solution, paving the way for process improvement and significant cost reductions, inclusive of energy consumption Breakthrough & creativity with regard to existing technologies / processes: Usual technologies require expertise in specific programming of PLCs and SCADA + substantial validation effort, at least delaying innovation by half a year and sometimes never coming to an end. Even sometimes programming languages simply do not enable to implement enhanced algorithms, brilliant ideas then eventually crash into this roadblock on innovation path. Expected savings, related to productivity as well as green savings amount to double digit figures Simple & Clever: no more than a well suited PC, an open source simulation software and scientific skill refer to figures on next slides 17

18 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 Describe how the solution answers each criteria (with examples if possible) Innovation behavior: This solution is new within sanofi and very likely beyond our company From budget perspective: accessible to the most penniless sites Collaboration with different entities / breaking silos Involvement and support of / from Operations, IS, R&D, external companies, University Sustainability / Green value Another immediate application is the control of thousands of Air Handling Units across our Production sites (120 plus), resulting in energy cuts of double digit figures This tool creates independency from odd and scarce languages: this PC platform (SAWv7 + SCILAB), by concept ensures solution portability, as a result this solution appears as sustainable over 2 decades from now on. 18

19 A bit of -on line- science in Pharma manufacturing WYSIWIG 2.0 WYSIWIG 2.0: What You Simulate Is What You Get monitor control Benefit = 250 k / year / equipment About 200 similar equipment across IA potential 25 Mi for this sole category of equipment 30 Mi when applied to HVAC control 19

20 Crea%ve Mindset, Innova%ve Solu%ons Thank you! IS Innovation Awards 2011: Communication Kit 20