1. F. MolnarSlide 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. F. MolnarSlide 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. F. MolnarSlide 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. F. MolnarSlide 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. F. MolnarSlide 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. F. MolnarSlide 6 Activity Desing Construction and building Control System programme design Quality assurance Development Explosion proof practice Maintenance

7. F. MolnarSlide 7 Design Studies, Basic instrumentation design, Construction plans, Execution plans.

8. F. MolnarSlide 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. F. MolnarSlide 9 Validation Validation before installation. Installation validation. Validation of the operation. Software validations. GAP analysis Risk analysis

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

11. F. MolnarSlide 11 Explosion proof activities 7 certified experts

12. F. MolnarSlide 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. F. MolnarSlide 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 cabinets of 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 Guedu dryer (Kemia 2) (21CFR) Above projects are based on Emerson’s DeltaV DCS (Distributed Control System).

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

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

19. F. MolnarSlide 19 Trend1

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