Introducing: BioXpert. Supervisory Control and Data Acquisition Software

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1 Introducing: BioXpert Supervisory Control and Data Acquisition Software

2 Applikon Biotechnology SUPERVISORY CONTROL AND DATA ACQUISITION SOFTWARE BioXpert Introducing: BioXpert 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 logical 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. Various BioXpert versions have been developed based on international standards for use in either research and pilot plant or production environments. BioXpert Lite is designed for data collection, data storage and data presentation. The research versions (BioXpert 1 and 2) offer maximum flexibility to set up and to modify processes. The pilot plant and production version (BioXpert XP) focuses 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. SCADA, Supervisory Control And Data Acquisition PID Control I/O modules Sensors and actuators

3 Laboratory Pilot Plant Applikon Biotechnology Projects Data collection BioXpert seamlessly integrates with Applikon controllers and other peripheral equipment to enable 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 measurements can be added to the process data to be used for calculations or advanced process control. measurements or calculated variables. The trend graph can also combine the values from different active and/or historic processes in one graph. The table presentation shows all measured data in tabular format. This gives the exact value of all parameters at any time during the process. The bar graph presentation can be used for a quick overview of the controlled parameters of a process. Data presentation BioXpert offers different ways of presenting your measured data. The trend graph shows the historical and actual values of up to 10 parameters in one graph. These parameters can be on-line measurements, off-line 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.

4 SUPERVISORY CONTROL AND DATA ACQUISITION SOFTWARE BioXpert Remote Access For BioXpert XP a special tool is available. process data without the need to physically be in the laboratory. Remote Access for BioXpert XP is based on web browser technology and makes BioXpert process data accessible 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 remote access program allows viewing of BioXpert 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 predefined calculations include oxygen uptake rate and a number of other frequently used parameters. Report trend viewer

5 Laboratory Pilot Plant Applikon Biotechnology Projects Remote alarm Supervisory 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. Recipes Processes are defined in recipes. These recipes can be executed in different bioreactors. The advantage of this approach is that repeatability of processes 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 control actions. Complex actions like automatic sterilization, cleaning procedures and constant total gas-flow for dissolved oxygen control can be programmed in BioXpert. Validation International standards used during the development stage of the software and safety features are the basis for the validatable BioXpert software. 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. Additional features and functionality in the software 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.

6 SUPERVISORY CONTROL AND DATA ACQUISITION SOFTWARE BioXpert Report Generator The Report Generator for BioXpert XP makes it possible to create process reports in compliance with 21 CFR part 11. Every graph and table has its own unique electronic signature. This allows comparison of process data on BioXpert XP Report 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 screen and on paper without a chance of mixing up information. 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. Electronic signature input

7 Laboratory Pilot Plant Applikon Biotechnology Projects Features BioXpert Lite BioXpert 1 BioXpert 2 BioXpert XP Operating system Windows NT, Windows 3.x, Windows NT, Windows XP 2000, XP 95, , 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 management BioXpert Lite BioXpert 1 BioXpert 2 BioXpert 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 BioXpert Lite BioXpert 1 BioXpert 2 BioXpert XP Line graphs Yes Yes Yes Yes Maximum number of pens per graph 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 Supervisory control BioXpert Lite BioXpert 1 BioXpert 2 BioXpert 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 BioXpert Lite BioXpert 1 BioXpert 2 BioXpert 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 Batch reports supported No No No Yes

8 BIOXPERT SUPERVISORY A U T O C L A V CONTROL A B L E S YAND S T DATA E M S ACQUISITION SOFTWARE About us Laboratory Pilot Plant Projects 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 expertise in Fermentation technology Validation procedures Cell culture technology Mechanical and electronic engineering Process engineering Control system engineering Sterile and hygienic processing Software development and automation Our product range consists of 7 liter Bio Bench Laboratory Glass Autoclavable Bioreactor systems ranging from 1 to 20 liter Stainless Steel SIP* Bench top Bioreactor systems ranging from 7 to 30 liter Pilot System 60 liters Pilot Plant Stainless Steel Autoclavable Bioreactor systems ranging from 20 to 110 liter Stainless Steel SIP* Pilot Bioreactor systems ranging from 20 to 140 liter Measurement, control and software 1500 liter Fermentor Projects Customized Bioreactor systems up to 2,500 liter * Steam In Place 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: Fax: biotech@applikon.com Applikon Biotechnology - V1XP Subject to modifications - Printed by Applikon Dependable Instruments bv - The Netherlands August 2004