The Case for TEVA Pharmaceutical. Cop yri g h t 2014 OSIso f t, LLC.

Transcription

1 The Case for TEVA Pharmaceutical Presented by László Simon Cop yri g h t 2014 OSIso f t, LLC.

2 Agenda About TEVA Challenges Meeting with PI System Solution and Application examples PI DataLink (Excel Add-Ins) PI Batch Generator (PIBaGen) PI ProcessBook Benefit Future Opportunities Conclusion 2

3 TEVA TAPI Worldwide: 20 Sites US: TAPI-Missouri Mexico: TAPI-Mexico TPW: Puerto Rico: Debrecen TAPI PR (Guayama) Sajobabony TAPI PR (Humacao) Theramex Monaco Italy: Sicor Santhia Rho PFC Caronno Bulciago Settimo Villanterio Czech: TAPI Galena Israel: Plantex Abic Teva Tech Croatia: Pliva (Zagreb SM) Antibiotics HP & Others Fermentation Synthetics China: TAPI China TPC 3

4 TEVA Hungary Debrecen Area: m² Main activities: solid dosage form & API production, R&D activities Sajóbábony Area: m² Main activity: API production Gödöllő Area: m² Main activities: sterile production, R&D activities 4 4

5 Challenges Regulated Industry Released PO PO BOM & Control recipe BOM MRP / Scheduling Masters Control recipe preparation Warehouse (Picking) Released Batch Training Batch Report Lab Authorisation Control Recipe Weighed ingredients Picking List Batch release Control Logbook recipe SOP Manufacturing Weighing center 5

6 Challenges Very strong validation requirements Stability even lack of flexibility Today, subject to high economic pressures Improve industrial performance Paper is the major challenge for better performance «Typical» Manufacturing process Released Poduction Orders PO BOM & Control Recipe BOM Masters MRP / Scheduling Control Recipe preparation Warehouse (Picking) Training Lab Authorization Control Recipe Picking List Batch Release Batch Report Weighed Materials Batch release Control Recipe SOP Equipements Logbook Weighing Center Manufacturing 6

7 Challenges - DATA The fermentation cycle takes a few weeks, we have to make a judgment according to the process values with a goal of ensuring final product quality. DATA > It s better to have it and not need it, than need it and not have it. C o pcyor ipgyhrti g2h0t OSIs o f t, LLC. 7

8 Meeting the PI System 8

9 Application: PI System and PAT(= Understanding + controlling the manufacturing process) PAT Advanced Control Quality build in by design Right first time monitoring product quality Real-time release Closed loop control Classic control Temp., ph, po2, pressure, MVDA monitoring process data Lab LIMS Process feed Process Analyzer Hold / release Sample Process output 9

10 Application: PI System and PAT(= Understanding + controlling the manufacturing process) PAT Advanced Control Quality build in by design Right first time monitoring product quality Real-time Infrastructure for monitoring Performance Availability - Security Real-time release Closed loop control Process feed Classic control Temp., ph, po2, pressure, Process Data MVDA PI System Lab LIMS Hold / release Sample Process Analyzer Process output 10

11 PI System Architecture 11

12 PI System Architecture 2000 tags PI Interface for OPC DA (2 pcs) PI Batch Generator (PIBaGen) PI Server PI Interface node PI Data Access PI-SDK Matrikon Data Manager OPC Server PI Interface for OPC DA PI Buffering PI Server PI AF PI Event Frames Batch KEPware OPC Server PI Interface for OPC DA PI Buffering Tag Data Assets & Attributes Event Frames & Attributes 12

13 The PI System in Virtual Environment 13

14 PI System Management Tools (PI SMT) 14

15 PI SMT - Point Configuration and the Excel Add-Ins C o pcyor ipgyhrti g2h0t OSIs o f t, LLC. 15

16 PI Batch Generator example C o pcyor ipgyhrti g2h0t OSIs o f t, LLC. 16

17 PI Batch Generator example C o pcyor ipgyhrti g2h0t OSIs o f t, LLC. 17

18 PI Batch Generator example C o pcyor ipgyhrti g2h0t OSIs o f t, LLC. 18

19 PI BatchView with PI ProcessBook 19

20 PI BatchView with PI ProcessBook 20

21 PI DataLink Excel application example (simple reporting) 21

22 PI DataLink Excel application example (simple reporting) 22

23 PI DataLink Excel application example (simple reporting) 23

24 Benefit Less paperwork Site-wide process visibility Batch tracking, investigations Users can get the data what they need 24

25 Future opportunities Batch Reporting based on RtReports More data source - PI Server extension More eyes on PI System new clients MES integration Technology transfer from Glass lab to full scale manufacturing 25

26 Conclusion Business Challenge Solution Results / Benefits Automate the manufacturing workflow Provide an easy tool for comparing and analyzing batches Provide a standard rapid an cost effective approach to capturing key process data PI System with Batch functionality Less paperwork More focus on process less time with data mining Optimized batch cycle time Better equipment utilization 26

27 László Simon Head of Automation TEVA Hungary 27

28 Questions Please wait for the microphone before asking your questions State your name & company 28

29 Brought to you by Cop yri g h t 2014 OSIso f t, LLC.

30 Please don t forget to Complete the online survey for this session eventmobi.com/emeauc14 Share with your friends #UC2014 Cop yri g h t 2014 OSIso f t, LLC.