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BatchCo n trol Process Control Development Ltd

BatchCo n trol Process Control Development Ltd. BatchControl Ltd Hungary , 1043 Budapest Dugonics u. 11. www.batchcontrol.hu Dr. Lajos Böröcz lborocz@batchcontrol.hu. Founder member of Hungarian Batch Forum. About BatchControl Ltd. Mission: „Competence in batch control”, It means:

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BatchCo n trol Process Control Development Ltd

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  1. BatchControl Process Control Development Ltd BatchControl Ltd Hungary, 1043 Budapest Dugonics u. 11. www.batchcontrol.hu Dr. Lajos Böröcz lborocz@batchcontrol.hu Founder member of Hungarian Batch Forum

  2. About BatchControl Ltd Mission: „Competence in batch control”, It means: our company has specialized in the problems of batch control area, and has become the specialist to solve them.

  3. BatchControl Ltd • Foundation: 1991 • Origin: CHINOIN Pharmaceutical Factory (now Sanofi-Aventis) • Employees : 20 • Engineers: 17 • Capital: 480 000 Є • Sales volume: 1 000 000 Є

  4. Possible Partners We look for: Pharmaceutical and chemical production companies applying batch control processes for reactors Food processing companies (e.g. beer), building material production companies (e.g. cement) applying similar technologies Engineering companies working for the pharma industry ( Like Jacobs from Italy, Tecnimont from Belgium, Novo Nordisk Engineering from Denmark- we have no contact to them )

  5. Our strengths • Batch (control) analysis • Batch control strategies • Batch algorithms • Recipe control • Operations • PLC programing • DCS programing • Control Systems Validation • Protocols • Test practices including software tests • Installation Qualifications • Operational Qualifications • 21 CFR Part 11 • Project Execution Procedure • Based on Good Automated Manufacturing Practice (GAMP) • Based on Baseline recommendations • Based on validation requirements • Integration of package units

  6. Activity • Desing • Construction and building • Control System programme design • Quality assurance • Development • Explosionproof practice • Maintenance

  7. Design • Studies, • Basic instrumentation design, • Construction plans, • Execution plans. AutoCad EPLAN WSCAD GD_ACCESS

  8. Construction and building • Production of control panels. • Installation of instruments both in the production area and in the instrument rooms. • Putting in operation of instrumentalisation elements. • Tests • Configuration of process control systems (DCS/PLC/SCADA)

  9. Validation • Validation before installation. • Installation validation. • Validation of the operation. • Software validations. • GAP analysis • Risk analysis

  10. Development • Solution of unique process control problems • Development of special SWs • Simulations, application of models • Training

  11. Explosion proof activities • 7 certifiedexperts

  12. Main customers • Sanofi-Aventis CHINOIN, • Richter Gedeon Chemical Works, • EGIS Pharmaceutical Works (major shareholder is the French Servier Group), • GlaxoSmithKline Biologicals, • VALEANT (ICN), • Biogal,

  13. References – CHINOIN • Control systems of CHEMIFLEX reactors (validated) • Process control systems of active ingredient (TD) production (validated) • Process control system of multipurpose plant (validated) • Enlarging of process control system of multipurpose plant (validated) • Process control system of active ingredient (SR) production (validated) • Process control system of pilot plant (validated) • Control system of climate cabinetsof PW systems. • Instrumentation of Prostaglandin plant • Process control system of active ingredient (Kemia 2) production (21CFR) • Process control system of active ingredient (Kemia 1) production (21CFR) • Process control system of Guedudryer (Kemia 2) (21CFR) Above projects are based on Emerson’s DeltaV DCS (Distributed Control System).

  14. References – RICHTER • Process control system of WFI (old water system)(validated) • Measurement of TOC of PW/WFI water • Planning of process control system of new WFI system (validated) • Process control system of active ingredient (Kemia 3) production (validated) • Process control system of dissolving equipment (validated) • CHEMIFLEX system (Kemia 3)

  15. References – others • PharmaPark - Validation activity of building management system (21CFR Part 11). • GlaxoSmithKline Biologicals – Enviroment monitoring system • GlaxoSmithKline Biologicals – Vaccine Plant • EGIS – • Producing of active ingredients under pressure. • Low volume active ingredient production - instrumentation plans • Active ingredients production (resolving plant) • Glatt dryer • Lenticular homogenizator

  16. Batch analysis Units Control policy User Specification HMI Process Analysis (Risk Analysis) Structure definition Positioning of tasks Generation of lists HMI requirements Level of automation Loops Physical Model Proces description Actuators P&ID Process Model Operations

  17. Integration of package units based on S88.01 models Control tasks can be allocated to: • central control system (e.g. DCS) • control device of Package Unit (PLC)

  18. Specialities • High accuracy of heat control • Compact solution of the thermo block (newly invented, under registration)

  19. Trend1

  20. Highest publications success Lipták, B.G. and Molnár, F. Instrument Engineers' Handbook, Process Control Volume, Reactor Control, 3rd Edition, Chilton Book Company, 1995.

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