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
F. Molnar
Slide 1
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.
F. Molnar
Slide 2
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
F. Molnar
Slide 3
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 )
F. Molnar
Slide 4
Our strengths
•
Batch (control) analysis
•
Batch control strategies
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Control Systems Validation
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Batch algorithms
Recipe control
Operations
PLC programing
DCS programing
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
F. Molnar
Slide 5
Activity
• Desing
• Construction and building
• Control System programme
design
• Quality assurance
• Development
• Explosion proof practice
• Maintenance
F. Molnar
Slide 6
Design
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Studies,
Basic instrumentation design,
Construction plans,
Execution plans.
F. Molnar
Slide 7
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)
F. Molnar
Slide 8
Validation
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Validation before installation.
Installation validation.
Validation of the operation.
Software validations.
GAP analysis
Risk analysis
F. Molnar
Slide 9
Development
• Solution of unique process control
problems
• Development of special SWs
• Simulations, application of models
• Training
F. Molnar
Slide 10
Explosion proof activities
• 7 certified experts
F. Molnar
Slide 11
Main customers
– Sanofi-Aventis CHINOIN,
– Richter Gedeon Chemical Works,
– EGIS Pharmaceutical Works (major
shareholder is the French Servier Group),
– GlaxoSmithKline Biologicals,
– VALEANT (ICN),
– Biogal,
F. Molnar
Slide 12
References – CHINOIN
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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).
F. Molnar
Slide 13
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)
F. Molnar
Slide 14
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
F. Molnar
Slide 15
Batch analysis
Units
Control policy
User
Specification
Level of
automation
HMI
Process Analysis
(Risk Analysis)
Structure definition
Positioning of tasks
Proces
description
Generation of lists
Loops
Physical
Model
HMI requirements
Actuators
P&ID
Process
Model
F. Molnar
Operations
Slide 16
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)
DCS
1
Recipe
unit procedure
PLC
Equipment unit
procedure
2
Recipe
operation
Equipment
operation
3
Recipe phase
F. Molnar
Equipment
phase
Slide 17
Specialities
• High accuracy of heat control
• Compact solution of the thermo block
(newly invented, under registration)
F. Molnar
Slide 18
Trend1
F. Molnar
Slide 19
Highest publications success
Lipták, B.G. and Molnár, F. Instrument
Engineers' Handbook, Process Control
Volume, Reactor Control, 3rd Edition,
Chilton Book Company, 1995.
F. Molnar
Slide 20