Introducing: BioXpert. Supervisory Control and Data Acquisition Software

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Introducing: BioXpert

®

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Introducing: BioXpert

®

Various BioXpert®_versions

have been developed based on international standards for use in either research and pilot plant or production environ-ments. BioXpert Lite is designed for data collection,

data storage and data presentation. The research versions (BioXpert®_{1 and 2) offer maximum}

flexibi-lity to set up and to modify processes. The pilot plant and production version (BioXpert®_XP)

focu-ses on process repeatability and data security.

The most recent release BioXpert®_{XP, allows the user to}

operate the bioreactor systems in compliance with the FDA’s 21 CFR part 11 guidelines. Via web browser technology the BioXpert®_{XP data is accessable}

throughout a network with the Remote Access. To create process reports in compliance with 21 CFR part 11, BioXpert®_{XP uses the Report Generator.}

Control concept

BioXpert®_{is installed on a PC that can be part of a local network. Data from sensors and actuators is}

read by BioXpert®_{from the local controllers and stored in the database. The data can be used for advanced}

process control in BioXpert®_.

BioXpert®

Applikon Biotechnology

S U P E R V I S O R Y C O N T R O L A N D D A T A A C Q U I S I T I O N S O F T W A R E

SCADA, Supervisory Control And Data Acquisition

PID Control I/O modules

Sensors and actuators BioXpert®_{is a software tool to control bio-processes and to store the process data. The software is} designed specifically for biotech researchers and operators in the production environment. The logi-cal structure of the program and the user-friendly interface allows the program to be used by anyone. That is why over 1,000 packages of our BioXpert®_{software are in use worldwide. The software is easy} to operate and has extensive functionality for monitoring, collecting and storing data and controlling processes. This allows any bioprocess to be easily optimized and controlled using Applikon software.

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Projects

Laboratory Pilot Plant

Applikon Biotechnology

Data collection

BioXpert®_{seamlessly integrates with Applikon}

controllers and other peripheral equipment to ena-ble you to get the maximum out of your bio-process equipment. All process data and controller data can be stored at user-defined intervals. Off-line meas-urements can be added to the process data to be used for calculations or advanced process control.

Data presentation

BioXpert®_{offers different ways of presenting}

your measured data.

Thetrend graphshows the historical and actual values of up to 10 parameters in one graph. These parameters can be on-line measurements, off-line

measurements or calculated variables. The trend graph can also combine the values from different active and/or historic processes in one graph.

Thetable presentation shows all measured data in tabular format. This gives the exact value of all parameters at any time during the process.

Thebar graphpresentation can be used for a quick overview of the controlled parameters of a process.

Data can also be displayed as a scatter plot. The X-axis can be any chosen parameter. This allows plotting one variable against another variable e.g. biomass concentration versus optical density. In this way, you can easily find the correlation between any two parameters.

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BioXpert®

For BioXpert®_{XP a} spe-cial tool is available. Remote Access for BioXpert®_{XP is based on} web browser technology and makes BioXpert® pro-cess data acpro-cessible for monitoring throughout a network. This enables any network station to be a view station for BioXpert®_{. Of course, access to the} BioXpert®_{data is coupled to the password access} security of the main BioXpert®_{program. The} remo-te access program allows viewing of

process data without the need to physically be in the laboratory.

BioXper t® _{XP Remote Access offers}

• Secure access to process data over the network • Viewing BioXpert®_{processes from any}

computer within the network

• Comparing data from different active processes • Remote viewing of operator actions

• Remote viewing of alarms

• Definition and storage of user-specific graph and table templates for remote viewing

Calculations

The on-line calculations of BioXpert®_{can be used to calculate derived variables. Based on the oxygen}

and carbon dioxide concentration in the off-gas, the respiratory quotient can be calculated. Other pre-defined calculations include oxygen uptake rate and a number of other frequently used parameters.

Report trend viewer

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Projects

Remote alarm Super visor y control

The statement editor and interpreter allow time and/or event based execution of advanced control strategies. Set points can be changed based on process time or as a result of measured variables. Complex actions like automatic sterilization, clea-ning procedures and constant total gas-flow for dis-solved oxygen control can be programmed in BioXpert®_.

Profiles

Another option for supervisory control is the use of profiles. These profiles are used for time-based changes of set points and analog outputs to control pumps and flow devices.

Recipes

Processes are defined in recipes. These recipes can be executed in different bioreactors. The advan-tage of this approach is that repeatability of

proces-ses is guaranteed. Every process is executed in exactly the same way as the previous one when the same recipe is used. Recipes allow definition of all process variables calculations and supervisory con-trol actions.

Validation

International standards used during the develop-ment stage of the software and safety features are the basis for the validatable BioXpert®_software.

Additional features and functionality in the soft-ware contribute to, and enhance the validation of your process. For instance, all system events and parameter changes by user operations are logged and secured by the system. These data cannot be manipulated, which contributes to the validation of the process. Applikon can provide the user with a fully-documented validation package.

The optional 21 CFR part 11 module allows full compliance with this FDA guideline.

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BioXpert®

Electronic signature input

The Report Generator for BioXpert®_{XP makes} it possible to create pro-cess reports in com-pliance with 21 CFR part 11. Every graph and table has its own unique electronic signatu-re. This allows comparison of process data on screen and on paper without a chance of mixing up information.

BioXper t® _{XP Repor t Generator offers}

• Printing of process data in line graphs • Printing of process data in table format • Exporting of process data

• Secure access to process data

• Comparison of data of multiple active processes • Comparison of data of active and archived

processes

Safety and High-Level User Security

Every operator can get specific user access rights to the program. The system administrator can define who is allowed to execute different parts of the programs. Options are unlimited and include viewing-only, changing graphic display layout, changing process parameters, defining recipes and many others.

Report Generator

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Projects

Features BioXper t Lite BioXper t 1 BioXper t 2 BioXper t XP

Operating system Windows NT, Windows 3.x, Windows NT, Windows XP

2000, XP 95, 98 2000, XP

Communication drivers included ADI 1010, ADI 1010, ADI 1010, ADI 1010, ADI 1030 ADI 1020, ADI 1020, ADI 1030, ADI 1030, ADI 1030, ADI 1060, ADI 1060, VG mass spec., ADDA card Sartorius balance, Sartorius balance,

DCU, ADDA card DCU, ADDA card

Measurement of process values from process controllers Yes Yes Yes Yes

Control of process setpoints in process controllers No Yes Yes Yes

Starting and stopping of controlloops No Yes Yes Yes

Programming of local process controllers No No No Yes

Reading of calibration data No No No Yes

21 CFR part 11 compliant No No No Yes

Gamp 4 compliant No Yes Yes Yes

ISA S88 standard No No No Yes

Password protection No No No Yes

User definable acces rights No No No Yes

Auto start after power failure No No No Yes

Data manag ement BioXper t Lite BioXper t 1 BioXper t 2 BioXper t XP

On-line data collection Yes Yes Yes Yes

Off-line data collection Yes Yes Yes Yes

Additional drivers available separately No No No Yes

Data storage system Proprietary Proprietary Proprietary SQL database file format file format file format

Minimum sample frequency 1 minute 1 minute 1 minute 1 second

Sample frequency selectable per parameter No No No Yes

Data export to Excell Yes Yes Yes Yes

Data storage in ASCII format Yes Yes Yes Yes

Graph export in BMP format Yes Yes Yes Yes

On-line calculations using on-line and off-line data No Yes Yes Yes

Data display BioXper t Lite BioXper t 1 BioXper t 2 BioXper t XP

Line graphs Yes Yes Yes Yes

Maximum number of pens per graph 10 10 10 10

Bar graphs Yes Yes Yes Yes

Synoptic Yes Yes Yes Yes

Procedure flow chart No No No Yes

Combination of current and historic data in graphs Yes Yes Yes Yes

Combination of different active batches in graphs Yes Yes Yes Yes

Measured data table display Yes Yes Yes Yes

Scatter plots Yes Yes Yes Yes

Storage of predefined graph setting Yes Yes Yes Yes

Super visor y control BioXper t Lite BioXper t 1 BioXper t 2 BioXper t XP

Programming of time based actions No Yes Yes Yes

Programming of event based actions No Yes Yes Yes

Profiling of setpoints No Yes Yes Yes

Manual setting of local control setpoints No Yes Yes Yes

Recipe definition No No No Yes

Other BioXper t Lite BioXper t 1 BioXper t 2 BioXper t XP

Logbook for process and equipment remarks Yes Yes Yes Yes

Event viewer for system comments Yes Yes Yes Yes

Audit trail No No No Yes

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Applikon Biotechnology

Applikon Biotechnology is a privately-owned Dutch company developing, manufacturing and supplying bioreactor systems for both research and production use. Starting in 1973 Applikon has grown from a small-sized company supplying laboratory instrumentation to a dynamic worldwide enterprise capable of supplying a broad and diverse line of bioreactor systems. Our autoclavable bioreactor systems are the worldwide industry standard. Applikon’s ISO 9001 certification and our ISO certified manufacturing partners ensure that only products made to the highest standards are delivered to our customers.

Applikon Biotechnology has exper tise in •Fermentation technology

•Cell culture technology •Process engineering

•Sterile and hygienic processing

•Glass Autoclavable Bioreactor systems ranging from 1 to 20 liter

•Stainless Steel SIP* Bench top Bioreactor systems ranging from 7 to 30 liter

•Stainless Steel Autoclavable Bioreactor systems ranging from 20 to 110 liter

•Stainless Steel SIP* Pilot Bioreactor systems ranging from 20 to 140 liter

•Customized Bioreactor systems up to 2,500 liter

* Steam In Place

7 liter Bio Bench

•Validation procedures

•Mechanical and electronic engineering •Control system engineering

•Software development and automation

•Applikon has been providing customers with software and control system solutions since the middle of the eighties. The products are developed by software and electronics specialists in close co-operation with bioreactor users.

The software and the controllers are used from laboratory scale up to production scale and comply with major international pharmaceutical standards. Key features are ease of operation and high control accuracy.

Applikon Dependable Instruments bv / Biotechnology Division.

De Brauwweg 13, P.O. Box 149, 3100 AC Schiedam, The Netherlands. Phone: +31 10 298 35 55. Fax: +31 10 437 96 48. E-mail: [email protected]

www.applikon.com

Measurement, control and software Laboratory Pilot Plant

1500 liter Fermentor Projects Pilot System 60 liters

Applikon Biotechnology -V1XP120011 -Subject to modifications -Printed by Applikon Dependable Instruments bv -The Netherlands August 2004 A U T O C L A V A B L E S Y S T E M S B I O X P E R T®_{S U P E R V I S O R Y C O N T R O L A N D D A T A A C Q U I S I T I O N S O F T W A R E} About us

Laboratory Pilot Plant Projects