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Control de bioprocesos con supervisión combinado con captura de datos
BioPAT® MFCS/win – el software estándar a nivel mundial para el control de bioprocesos con captura de datos. Basada en más de 25 años de experiencia y más de 2.300 instalaciones, la versión más reciente de BioPAT® MFCS/win ofrece diversas soluciones para atender sus necesidades particulares.
Control de procesos desde
- upstream hasta downstream
- frasco de agitación hasta gran escala
- un solo uso hasta reutilizable
Integrate the capabilities of advanced multivariate methods into your BioPAT® MFCS/win process control software!
The BioPAT® MFCS/win MVDA module enables you to overcome labour bottlenecks for time-consuming data preparation tasks. The module automatically preformats and transfers historical data sets of multiple batch processes from MFCS/win to BioPAT® SIMCA which leads to a quick and reliable interpretation of batch results.
The BioPAT® MFCS/win OPC HDA Server ensures real-time data transfer from running bioprocesses to BioPAT® SIMCA-online. In addition, the simultaneous transfer of historical data gives extra process safety in costly commercial manufacturing processes. Unique algorithms for early fault detection and isolation save batches and prevent expensive post-process deviation handling.
The BioPAT® MFCS/win DoE module provides an easy start into designed experiments with user-friendly wizard guidance. The transfer of the design into a specific recipe allows a reliable and seamless integration of DoE procedures into existing control strategies. BioPAT® MODDE, BioPAT® SIMCA and BioPAT® SIMCA-online are also available as standalone software.
- Mitigating the risk of producing a poor quality product
- Systematic cost savings through all production phases
- Reduce complexity and increase understanding of processes
S88 Recipe Control
In order to achieve a reproducible and fully automated batch process, a modern SCADA system has to provide possibilities to trigger different actions automatically by events.
BioPAT® MFCS/win allows you to mirror each step of your process by selection of customized recipes complying to the ANSI/ISA-88.01 standard for computerized batch control. Semi or fully-automatic operations, state or time-dependent transitions enable organized and structured batch processing as well as flexible manufacturing.
Reproducible batch runs
Reliable and robust automation
Graphical configuration and execution
21 CFR Part 11
The FDA rule relating to electronic records and signatures is a significant legislation. Where validation is required, SCADA systems must comply with 21 CFR Part 11.
BioPAT® MFCS/win supports all requirements to achieve full compliance. That means that your process can be evaluated, reviewed, approved and archived without a single sheet of paper and without the possibility to falsify process data and signatures. However, if required, all information can be printed and signed handwritten.
- Audits trails for all electronic records
- Unique electronic signatures & user management
- FDA accepted electronic format
Besides typical requirements as availability, reliability and scalability the consideration of security standards is of particular importance when adding a SCADA system to a business network.
BioPAT® MFCS/win can easily be integrated with network security into an existing architecture by distributed operator workstations. If required the SCADA environment can also be isolated from your company‘s network. Not only the strong expertise of our IT engineers but also the use of the latest Windows® or Citrix® terminal server solutions allow for closing any security vulnerability.
- Central administration & security configuration
- Client remote operation (e.g. from office PC)
- Easy data backup on file server
Process Analytical Technology (PAT) implicates the use of various measurement and control devices and hence needs a commitment to sophisticated automation solutions.
BioPAT® MFCS/win provides flexible device connectivity, true interoperability with major third-party products and control features which are second to none. Besides user-programmable or customized interfaces BioPAT® MFCS/win fully supports the OPC technology. „Plug & play“ communication to analytical instruments, real-time data input for MES systems or alarm & event notification on multimedia devices simplify your automation tasks.
Flexible device & sensor connectivity
Sophisticated control features
Modern Crossflow plants are equipped with sophisticated monitoring and control systems to ensure high consistency and robustness of purification.
BioPAT® MFCS/win is positioned on top of the local DCU control and used to control and document the Crossflow process by logging all kind of process data and information around the process. BioPAT® MFCS/win recipes and the DoE Module support fully automated optimization and robustness testing procedures, not only for concentration or diafiltration but also for clearing filtration and fractionation purposes.
Customized purification strategies with recipes
DoE for robustness studies
21 CFR Part 11 compliance
Sartorius provides different levels of trainings for the BioPAT® MFCS/win system which are integrated into the Sartorius Stedim Biotech service program.
These training are designed to ensure that each course participant has a proper understanding of the theoretical subject matter and acquires the necessary hands-on, practical skills. The ultimate aim and purpose is to enable, technicians and specialists working in R&D or production to perform their work safely and efficiently.
- Basic and advanced training programs
- Individual (in-house) trainings on request
- Certification as "qualified person“
Register for a free webinar today and learn more about our new BioPAT® MFCS/win solutions and innovative PAT projects.
Genuine value creation becomes feasible when products and services efficiently mesh together. Combined with expertise in project management, technologically and economically optimized solutions are guaranteed.
Our team of experienced service engineers has been involved in a number of successful projects world-wide. Expertise gained through long term cooperation with pharmaceutical and biotech companies has been used to develop and refine a comprehensive range of services including computer system validation (CSV) as well as qualification of automated process equipment.
- Installation & configuration
- Validation & engineering services
- Hotline, e-mail, remote & on-site maintenance
Sartorius is proud to support BioPAT® MFCS/win customers with continuous software improvements and adaptations to current operating systems by updates and service packs.
Regular updates and service packs are available for all current versions, plus free e-mail and optional hotline support as well as remote & on-site maintenance on demand. Sartorius maintains support for main versions of BioPAT® MFCS/win for approx. 10 years following General Availability (GA) of the software. The following table shows the support timeline (EOS: End of Support).
The BioPAT® MFCS/win Versions above include corresponding modules and components.
If you are considering upgrading to a current version, we can offer favorable upgrade options.
Please get in touch with us for further information.
MFCS/win Service Packs
Software Downloads require to fill in the form with your contact information. The form will be displayed with clicking on the Service Pack. Please ensure that you complete all boxes necessary to enable us to provide the service you require.
To check your serial number as well as version information of your MFCS/win system, press the button “System Info” on the MFCS/win Shell. The serial number is also displayed on the delivered USB Dongle or on the sticker on your MFCS/win server PC. If you experience any problems during download or installation, please use the contact form.