TruBio Bioreactor Control Software

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1 Data File #810-DST-001-Rev1 TruBio Bioreactor Control Software Ultimate bio-process scalability from bench top to full scale manufacturing Scalable Accelerate scale-up and scale-down Modular Configure, customize, or expand with ease Adaptable Connect with many bioreactor sizes and brands Reliable Use premium platforms DeltaV or Wintel Total Unify upstream processes with one common user interface

2 Bio-process Software Finesse Solutions has developed its two TruBio software platforms (DV and µc) with flexibility, reliability and state-of-the-art control capability for cell culture and fermentation. Finesse TruBio software and G3 bioreactor controllers provide unprecedented control of bio-processes. TruBio software satisfies control needs at all scales of process from a start-up research organization to global biologics manufacturing. Dependable software for cgmp production TruBio DV software is hardware-independent, highly configurable software powered by the DeltaV control platform from Emerson Process Management. TruBio DV has been developed with the latest GAMP revision methods and validated for cgmp applications. It is fully compatible with DeltaV versions 9.3 through TruBio DV software provides automation hardware independence and allows third party data to be seamlessly acquired and used to build sophisticated process control strategies. TruBio DV software is pre-configured with algorithms for controlling bioprocess parameters such as ph, dissolved oxygen, temperature, pressure, and feed strategy. With tridundant sensor loops as well as unlimited gas and liquid addition capability, TruBio DV software can be used with glass vessels, wave rockers and most brands of single-use bioreactors to provide perfect process control from R&D through production. TruBio DV can also unify all upstream process trains and enable easy scale-up and scale-down between R&D, process development, and cgmp manufacturing. For highly demanding upstream applications such as perfusion, TruBio DV enables rapid integration of peripherals (scales, pumps, sensors) and off-line analyzers. Comply with cgmp regulations and mitigate risk All TruBio control software platforms have an embedded historian database that simplifies the collection of real-time data from all bioreactors. To secure batch record or experiment-design data, TruBio DV enables a secure OPC connection to all standard reporting tools: OSI Pi, CrystalReports and DreamReport. Once process parameters are selected and the data transfer validated by your quality assurance group, expedite batch release with automated reporting and minimize compliance risk. Manual laboratory entries can also be stored in TruBio DV and transferred into the DeltaV database.

3 Configurable SCADA software for equipment harmonization TruBio DV SCADA has been developed to harmonize and upgrade an installed base of older, proprietary bioreactor control systems. A migration occurs when the existing bioreactor controllers can no longer meet current bio-process needs. TruBio DV SCADA then provides a cost-effective solution by which the existing process hardware is retained, but is enhanced with the capability and features of TruBio software and is bolstered with the reliability and power of the DeltaV automation platform. A proprietary, closed controller now becomes fully configurable and open. The overlay of TruBio DV SCADA onto third party controllers and analyzers is executed by using either Finesse TruConnect hardware or OPC connectivity through an Application Station. Third party sensors or digital MFCs can also be added to existing controller hardware by using spare DeltaV I/O in the TruLogic controller. TruBio DV SCADA software is a cost-effective means to extend the useful life of existing capital, unify the user interface for a variety of controllers (Sartorius, Applikon, DasGip, NBS), and aggregate process data in a common, robust DeltaV historian. Flexible software for process development TruBio µc harnesses the processing power of the Wintel platform to achieve smart control that is fully scalable and works out-of-the-box. TruBio µc software also has many other advanced features already integrated for end user operating convenience. For example, data graphing and reporting are standard along with off-line data entry and electronic process notes. The RecipeManager add-in allows up to eight process phases to be easily entered, saved and executed. Running TruBio μc is truly click-and-process because all control loops are pre-tuned to the bioreactor vessel being used. The control loop parameters are stored in default vessel configuration files. Each vessel file is created using data obtained when the vessel is characterized (e.g., temperature and kla mapping), and contains all of the information required to control critical process parameters such as ph, dissolved oxygen, temperature, and feed strategy. TruBio µc software has been optimized to provide a cost-effective and user-friendly solution for small-scale or development needs without forgoing scalability. Large networks of bench scale bioreactors can be set up and configured for sophisticated design of experiment runs.

4 Smart OPC Servers Native OPC operability with 3rd party equipment Finesse SmartOPC servers integrate industry-leading OPC communication with the DeltaV control platform from Emerson Process Management. By leveraging OPC, a well-established communication protocol, Finesse SmartOPC servers enable the rapid and cost-effective integration of both large and small numbers of third party proprietary controllers into a DeltaV network running TruBio DV SCADA software. SmartOPC servers eliminate the need for multiple historians, HMIs, applications or devices by unifying all data and process recipes in DeltaV. TruBio DV SCADA allows users to develop more sophisticated control strategies using legacy equipment in a master-slave configuration with seamless integration of the native controller. Unify data and processes Finesse SmartOPC Servers for Sartorius DCUs and Applikon EZcontrollers provide direct, secure, and reliable connectivity to these controller units. This OPC Server makes it possible to increase the speed of process development by eliminating manual process of programming each controller and aggregating off-line data. Increased productivity reduces R&D and operating costs. SmartOPC servers bring enhanced process flexibility as an overlay, and allow users to store process data in a single historian database, while easily sharing information between different geographical sites. Real-time remote data access to a legacy controller or off-line analyzer has never been easier. Tested and proven communication and reliability Finesse SmartOPC servers are fully compatible with: Sartorius DCU (B/C) Applikon EZControl DasGip Quad Systems New Brunswick Scientific BioCommand Nova Bioprofile 400/FLEX

5 TruBio Network Architectures

6 Features and Specifications BASIC OPERATIONS Process Signal Conditioning Vessel Settings Key Parameter Display On Configuration Page Online Parameter Update Total (Liquid and Gas) Pages Analyzer Data Entry Pages User Access Configuration Electronic Signature Backup and Restore Procedure 21 CFR Part 11 Compliance CALIBRATION ph Sensor (one-point, two-point, slope / offset) DO Sensors (one-point, two-point) Temperature Sensors (one-point, two-point) Pressure Sensors (one-point, two-point) Pump Agitator Speed (one-point, two-point) Vessel Weight (zero, tare) Auxiliary Input

7 CONTROL AND SETTINGS ph Control Dissolved Oxygen Control Weight Control Auxiliary Input Control Agitator Speed Control Gas Flow Control Pump Control Foam Control Level Control MISCELLANEOUS Interlock Configuration ph / DO Sensor Redundancy Dual Triple ALARM MANAGEMENT Alarm Configuration Alarm Priorities Alarm Type Remote Access Notification RECIPE MANAGEMENT ISA 88 Batch Control Option Recipe Editor Option PROCESS DATA STORAGE Continuous Historian Audit Trail VERSION Current TruBio Release

8 Toll free Tel Fax Finesse Solutions, Inc. Global Headquarters 3501 Leonard Court Santa Clara, CA USA Europe Via Sogn Gieri 27a CH-7402 Bonaduz, Switzerland Asia-Pacific 3A Intl Business Park, #07-08 Tower A Singapore TruBio DV TruBio µc are registered trademarks of Finesse Solutions, Inc. DeltaV is a registered trademark of Emerson Process Management. Finesse Solutions, Inc., 2013.