DESIGN REQUIREMENTS FOR COMPONENTS AND SYSTEMS IN PVC COMPOUNDING FOR MEDICAL APPLICATIONS. Rochus Hofmann, Zeppelin Systems GmbH, Germany

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1 DESIGN REQUIREMENTS FOR COMPONENTS AND SYSTEMS IN PVC COMPOUNDING FOR MEDICAL APPLICATIONS Rochus Hofmann, Zeppelin Systems GmbH, Germany

2 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 2

3 1. OUR VALUES go back to the founder of our company Archiv der Luftschiffbau Zeppelin GmbH Archiv der Luftschiffbau Zeppelin GmbH Archiv der Luftschiffbau Zeppelin GmbH THE PEOPLE AT ZEPPELIN make you think overcome boundaries tip their hats leave their footprint stay on course fail successfully move your heart attract Grafen get others on board receive support 3

4 ZEPPELIN STIFTUNG Administered by the city of Friedrichshafen Luftschiffbau Zeppelin GmbH Friedrichshafen FIGURES 2015 ZF AG Friedrichshafen Turnover: 29,2 bill. Employees: 138,300 Locations: 230 ZEPPELIN GmbH Friedrichshafen/Munich FIGURES 2015 Turnover: 2.33 bill. Employees: 7,800 Locations: 190 4

5 GROUP OVERVIEW Managementholding: Zeppelin GmbH Shareholders: Zeppelin Foundation/Luftschiffbau Zeppelin GmbH Turnover 2015: 2.33 bill. Employees: 7,800 (incl. trainees) Locations: 190 locations in 30 countries CONSTRUCTION EQUIPMENT EU CONSTRUCTION EQUIPMENT CIS RENTAL POWER SYSTEMS PLANT ENGINEERING Sales and service of construction machines Sales and service of construction and agricultural machines Rental and project solutions for construction and industry Propulsion & energy systems Plant engineering 5

6 SBU ZEPPELIN PLANT ENGINEERING From the local hopper fabricant to an international engineering company Locations worldwide: 19 Turnover: 328 mil. EUR in 2015 Employees worldwide: over 1,376 Shop floor area worldwide: approx. 60,000 m 2 Engineering worldwide: more than h per year Silos fabricated per year: 350 6

7 OUR SCOPE OF SUPPLY is oriented at the customers value added chain PRODUCER FORWARDER COMPOUNDER/ PROCESSOR Conveying, storage Cooling, degassing, drying Blending, dedusting Packing, loading, distribution Storage, conveying Metering, weighing, procssing, mixing 7

8 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 8

9 2. VALIDATION OF SYSTEMS Comprehensive validation includes raw materials, equipment, process, process parameters and control Processing Combine, mix and process individual raw materials according to recipe and processing methods Documentation Traceability from which raw materials the product has build up Documentation of the process conditions under which the product has build up, including the equipment / machines used 9

10 STANDARDS UND GUIDELINES Authorities, organizations FDA GMP+ GAMP 5 ICH Q9 EU-GMP PIC/S WHO Computer Software Validierung (CVS) GAMP 5 = Good Automated Manufacturing Practice GAMP is an accepted guide for the validation of computer-based systems GAMP is a quasi-standard, but not legally binding. 10

11 VALIDATION OF SYSTEMS Steps for successful validation time Analysis of the overall system Documented test with material General and detailed design specifications Documented test without material details Definition of documents Documented integration in the system Determination of the necessary tests Documented test of every unit at factory side Design mechanical and electrical Hard- and Software 11

12 FUNCTIONAL EXPIRATION OF VALIDATION DQ: Design Qualification Demand analysis Requirements Purchase contract GMP GAMP 5 Good Manufacturing Practice Good Automated Manufacturing Practice Verifying of installation and installed equipment IQ: Installation Qualification Document check Visual inspection FMEA HACCP PDS Failure Mode and Effects Analysis Hazard Analysis of Critical Control Points Process Design Specification FDS Function Design Specification Test of all functions under production conditions OQ: Operational Qualification HDS SDS DQ IQ Hardware Design Specification Software Design Specification Design Qualification Installations Qualification OQ Operational Qualification Verification of the required performance data PQ: Performance Qualification Operation Maintenance Calibration PQ FAT Performance Qualification Factory-Acceptance-Test 12

13 DESIGN OF VALIDATION SYSTEMS Requires comprehensive documentation of all project stages Replaces punctual quality assurance with a comprehensive concept Not legally binding, is based on nonsynchronized, partially contradictory international rules So far, limited to pharmaceuticals, medicine and partial foods Requires clear coordination with the customer about relevance, application, scope and delivery limit 13

14 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 14

15 3. 3D PLANNING OF THE PLANT 15

16 3D PLANNING OF THE PLANT Links site planning with component construction Enables the integration of a larger group of people into planning 3D scanners allow the recording of the building contours Complex space situations can be analyzed excellently Reduces construction site expenses by means of collision tests Another "view" of integrated engineering Integrated engineering is very helpful for the validation steps planning and documentation 16

17 INTEGRATED ENGINEERING WITH PDMS From the database-based planning tool (Comos PT) to 3D planning until now: Integriertes Engineering: Access - Claims - Std- kont. - etc. Word - Specs - Anfragen - Doku - etc. UNIPPS - Bestellung - Budget - etc. Excel - Data Sheets - Listen - etc. TRICAD - 3D Planung - Isometrie - P& ID s - etc. Power Point - Doku. - Infos - etc. And. Format - Doku. - Infos - etc. Verzeichnisstrukt ur Serverstruktur There is no logical link between the documents, each document stands alone! database Engineering Tool Reports z. B. construction lists LOOP Database as a basis 17

18 INTEGRIERTES ENGINEERING Working with objects PFD P&ID Berechn. Piping 3D Iso FUP MSR\ET Wartung P&ID Fuctional plan PFD OQ-Documents -Objekt- database e. g. Pump - FUP - Berechn - PID - PFD - EMR - 3D - ISO - service Loop 3D - Planning Isometrie PFD Etc. Operating manual 18

19 INTEGRATED ENGINEERING Summery Through integrated, database-driven planning, increasing, diverse requirements to the validation, supply chain, planning, etc. are met. Fulfilling the high demands placed on machinery and equipment for medical products Planning and construction of complex plants Through integrated, database-driven planning, increasing requirements for validation, supply chain, planning, etc. are met. 19

20 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment mixing concept 7 Summary 20

21 4. BATCH TRACING Laws and regulations to be considered EU Regulation 178/2002 (Focus on the Food and Feed Industry) or GMP + Consumer protection, proof of origin, labeling requirements Risk minimization, recall of defective products Quality control through the supply chain Asset validation Optimization potential Determination of liability 21

22 PRODUCT FLOW ALONG THE SUPPLY CHAIN (supply chain) Rohstoffe Händler, Veredler Endverarbeiter Traceability makes it possible to reconstruct the entire supply chain as well as parts of the supply chain. 22

23 REQUIREMENTS Unique identification of raw materials Documentation of critical processing steps, formulations, process parameters and quality control Clear identification of your own products and allocation of production lots Proper treatment of batching, overlapping, cleaning and carryover Traceable and accurate detection, recording and archiving of all necessary data, compressing to information 23

24 EQUIPMENT REQUIREMENTS No cross contamination 24

25 RETRACEABILITY Summary No mixing during storage, discharge and dosing Avoid cross-contamination and carryover No mixing of identical raw materials of different batches - clear assignment to batch number Careful cleaning of the containers Avoidance of data acquisition errors, control of manual operations Control concept and data compaction to information, communication with ERP systems Batch tracking does not end at the factory limit!! 25

26 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material For medical application 6 Equipment Mixing concept 7 Summary 26

27 5. SOFT PVC - P COMPOUNDING Standard soft PVC - homogeneous absorption of plasticizer - dry Dryblend - variable raw material selection - high throughput up to 9,5 batches/hr - with up to 85 % filling Important: Very fast plasticizer absorption Medical soft PVC - absolutely complete homogeneous plasticizer absorption - free-flowing Dryblend with no gelled agglomerates, - without any influence to the compounding parameters - nearly free of any pits - constant valuable parameter Important: Shear near the bottom 27

28 PROCESSING STEPS PVC-P FORMULATION Feeding of all components into the mixer. Heating of the mixture by friction up to approx C with a tip speed of up to 40 m/sec. Validation process: Reduction of tip speed to m/sec. Start to adding plasticizer, depending on the temperature increase after final liquid adding increase of speed up to 40 m/s After reaching the final temperature of C: Reduction of tip speed to 20 m/sec. Discharging into intermediate hopper or cooler mixer. If cooling is desired, cooling down to C. Documentation and recording of each processing step With - Times - Temperatures - Velocities 28

29 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 29

30 6. MIXING TECHNOLOGY Complex mixing tasks need intelligent solutions Applications Rigid and soft PVC Masterbatch and coating powder Natural fibre compounds Battery massas Chemicals, stabilisers, additives Coating, bonding Food Metal/ceramics (MIM/CIM) Technologies Mixer from 4 to 8,000 l Heating mixer Cooling mixer (vertical/horizontal) Universal mixer Container mixer Continuous mixer Laboratory mixer 30

31 HENSCHEL FLUID MIXER Motor Bearing Belt pulley bearing Belt tension Belt pulley Belt Belt pulley 31

32 DISCHARGE Easy cleaning with Swing-away cylinder Swing-away cylinder for faster, easier cleaning of the discharge area. 32

33 PVC-P PLANT FLEXIBLE PVC PLANT FOR MEDICAL HOSES WITH COOLING MIXER FLEXIBLE PVC PLANT FOR MEDICAL HOSES WITHOUT COOLING MIXER 33

34 PVC-P PLANT without any mixer for medical application Formulation: Bulk density: Throughput: medical hoses 0,60 kg/l 1,1 t/hr Inline compounding: All steps inside the Extruder: - Mixing, heating - difusion of plastciser - Melting - pressure buildup - profiling 34

35 PROCESS TECHNOLOGY Patented conical shaped mixing elements (EP ) with self-cleaning effect for soft and gentle melting of polymer and homogenising of fillers and/or fibers 35

36 PROCESS TECHNOLOGY screws HENSCHEL Compounder conventional Compounder Low shearing and less mechanical forces Homogenous thermal distribution without temperature peaks Reduced energy demand due to low torque Less wearing due to bigger gap between screw elements 36

37 COMPOUNDING WITHOUT MIXER process and production competent system for continuous preparation of PVC-P With: Consequent energy reduction Flexibility Reduction of building complexity 37

38 COMPOUNDING WITHOUT MIXER 1. Extreme energy savings (55%) (future energy cost, background energy transition) 2. Simple and clear production 3. Low installation expense 4. No segregation because intermediate storage is omitted 5. No cross-contamination and thus less damage and less scrap 6. Saving of up to 2/3 of the building height is possible 7. Strongly simplified standard buildings 8. Low cleaning expense for formulation or colour changes 9. High flexibility in recipe changes 10. Easier operation by means of less complexity and easier overall controls 38

39 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 39

40 7. SUMMARY Planning and documentation of the system for producing medical grades Planning and documentation of all materials used General documentation of every influencing factor in all processing steps Use automated and integrated Processes for planning and documentation Use optimized machines and equipment Planning and designing of optimized systems 40

41 VIELEN DANK FÜR IHRE AUFMERKSAMKEIT!

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