BatchControl Process Control Development Ltd

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

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BatchControl Ltd

• Foundation 1991
• Origin CHINOIN Pharmaceutical Factory (now
  Sanofi-Aventis)
• Employees 20
• Engineers 17
• Capital 480 000 ?
• Sales volume 1 000 000 ?

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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 )

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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

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Activity

• Desing
• Construction and building
• Control System programme design
• Quality assurance
• Development
• Explosion proof practice
• Maintenance

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Design

• Studies,
• Basic instrumentation design,
• Construction plans,
• Execution plans.

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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)

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Validation

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

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Development

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

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Explosion proof activities

• 7 certified experts

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Main customers

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

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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 Emersons DeltaV DCS
  (Distributed Control System).

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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)

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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

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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
PID
Process Model
Operations
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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)

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Specialities

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

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Trend1
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Highest publications success

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