Flexibility And Security
Bioengineering‘s control software Bioscada is not designed as isolated software package and enables integration of diverse interfaces. This creates flexibility and versatility for visualization, control and automation of biotechnological processes from laboratory scale to production plant without compromising operational safety and compliance with applicable regulations.
Fermentations and cell cultures are complex biotechnological processes which have to be conducted in bioreactors and equipment suitable for sterile operation. Only with exactly defined process management and with accurate control of process parameters such as temperature, agitator speed, DO, pH and foam formation expected product yields can be generated. Slight deviations of critical parameters can lead to metabolic changes or to death of the cultivated organisms. Both entail significant product losses.
Control loops are the basis of process control. Distinct controllers are exclusively used to monitor and control the control loops. Because of complex algorithms, process control is very precise. Modern pharmaceutical and biotechnological processes have to be documented seamlessly and in compliance with applicable regulations. Software as primary control system is not only commonly used today in biotechnological processes, but is often vital for proper process management.
Control software of a fermentation or cell culture plant does not only actuate controllers or control loops directly and achieve process automation, but also visualizes measurement values, puts them into context and documents them. Ideally it should make it easy to draw conclusions from former fermentations (e. g. OTR, CTR and RQ values) and to implement them into process optimization (e. g. for fed-batch control).
Control Concept
Bioengineering's intelligent combinations of hardware and software components which have been tailor-made to suit the process incorporate a multitude of functionalities. At the same time they provide the safety net required for laborious and expensive biopharmaceutical production processes.
The hardware is built up in modular levels. A controller level is integrated which is expandable, processes events quickly, and allows for retrospective implementation of functionalities. If the PC fails, all data are stored at the controller level and can be retrieved any time. This reliably prevents the loss of a batch which has been regularly conducted just because of a system crash of a single computer.
The software has been designed according to the ANSI/ISA-88 standard with a strictly hierarchical configuration in the form of a layer model. Each layer exclusively uses functions of the layer directly below and transfers results to the layer directly above. This enables simple, concise and reliable development of complex automation recipes. All operations are validated in the course of the acceptance test and because of the layered software design subsequent recipes do not have to be validated again.
Full Range Of Functionalities
The software Bioscada does not only manage visualization and control of biotechnological processes, but also provides a full range of functionalities to facilitate process management, increase process safety and secure reproducibility and compliance with regulations. These functions are applicable on all process levels. On the level of direct actuation of control loops or controllers the software allows for programming of profiles or interconnection of several controllers in a cascade. In case of alarm the operator can be immediately informed via SMS or e-mail. Automation of the plant is achieved via step sequence programming (unit procedures).
Data can be visualized and edited anywhere in an interlinked network of computers. For process documentation not only the generated data and measurement values are provided, but also all performed operations. This renders batches comparable not only in their outcome but also in their execution. Data can be displayed in any order and combination as line diagram, bar graph or 3D-chart. Detailed evaluation and processing of results is possible after data export to other programs (e. g. Excel). Multi-level user administration prevents unauthorized access and inappropriate manipulation. Despite of this multitude of functionalities Bioscada has been especially designed for compliance with 21 CFR Part 11.
Individual Development Process
Bioscada is not ready-made standard software, but is individually developed to specification for the respective process. Bioengineering applies the V-model for control system development. According to this model the project is divided into hierarchical subcategories and then all specifications are reviewed and realized in a multistage process.
Software development starts with the evaluation of the customer's system requirements. Expectations and necessities of the plant and the process are illustrated and discussed. Together with the sales personnel optimum components for the plant are selected and the type of control is defined.
Functional Design Specification (FDS) and Piping and Instrumentation Diagram (PID) illustrate customer specifications in a concise way. On this basis the architecture of process automation is determined in the Hardware Design Specification (HDS) and the Software Design Specification (SDS). After the concept is completed hardware and software are organized into clearly defined modules. Each of these modules is individually implemented and tested. During development the respective specifications are constantly reviewed. The development process of hardware and software components terminates with the acceptance tests and the handover to the customer. In the factory acceptance test (FAT) and the site acceptance test (SAT) equipment and software are checked for functionality and safety. All operations are validated at this stage.
This stepwise approach creates a powerful software which has been custom made for the specific process. Its degree of validation is selected in compliance with the applicable regulatory standards. The software dispenses with all functionalities unnecessary for the process. Thus it is not only more specific but also economically more feasible than inflexible mass software with a number of unneeded expensive functions.
Upscaling And Upgrading
Biotechnology is a modern science and new developments in process control are a necessity. Bioreactors are often first procured for development laboratories, where the future production process is designed and optimized at small scale. At this development stage the process is yet vaguely defined and subjected to major procedural changes. Hardware and software must be able to react flexibly when an alternative procedure is tried or when a promising method is optimized.
As soon as the definition of the process is completed in the development laboratory the upscaling begins. Step for step the process is brought to production scale in bioreactors of increasing size. In this phase of process development the control software does not need to have the same flexibility as in the development laboratory. Instead, all transitions to bioreactors next in size should be as smoothly as possible to ensure that generated data and know-how remain applicable.
Thus the control software must have great versatility, but at the same time should be designed as homogeneously as possible from laboratory scale to production plant of several thousand liters.
Bioscada puts these characteristics into practice with a uniform operator environment for all plant scales and for every degree of automation. During upscaling, developed automated processes can be directly adopted for further optimization in the next level. They do not have to be revised due to different automation strategies in small scale and large scale bioreactors.
Bioscada creates flexibility not only with a multitude of functionalities and the integrability of different interfaces but also because of its expandability. Like the machines of Bioengineering, Bioscada is modular. This means, the software can be gradually expanded in its functionality without interfering with existing software and hardware components. Thus initial investment costs can be kept low. The quality of the plant, however, does not have to suffer, because the control software is systematically upgraded with progressive development of the process.
Thus Bioscada is a process control software for plant operators who want to implement original creative ideas and who do not want to settle for ready-made standard systems.
