BatchControl Process Control Development Ltd

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BatchControl Process Control Development Ltd

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GlaxoSmithKline Biologicals Enviroment monitoring system GlaxoSmithKline Biologicals Vaccine Plant EGIS Producing of active ingredients under pressure. – PowerPoint PPT presentation

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Title: BatchControl Process Control Development Ltd

1
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
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 ?
Sales volume 1 000 000 ?

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
Explosion proof 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 certified experts

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 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).

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
PID
Process Model
Operations
17
Integration of package units based on S88.01
models