The use of MES systems allow us integrate production and management (horizontal and vertical), thus optimising production processes.
eBR is the MES (Manufacturing Execution System) solution for the pharmaceutical and cosmetics industry, which complies with the ISA 95 standard. This eBR software provides functionality and benefits for paperless manufacturing from an engineering, operational and quality perspective.
eBR combines the requirements for a MES and the system for the control, monitoring and reporting of core pharmaceutical processes and support processes, with the main objective being to simplify the tasks of the operator.
Based on high-level requirements, MES process control, with the DCS (PCS7) base, combined with electronic batch records (eBR), includes a native integration between both elements. This solution has already been successfully applied in numerous pharmaceutical industries.
Advantages of eBR
- Integration of the MES layer and the DCS layer, native.
- Numerous success cases of PCS7 deployments.
- Integration of the entire automation part, with the support of the product life cycle and the backing of a global company.
eBR can also be a MES solution that integrates with different recipe automation systems from other brands. Thanks to its versatility, it can adapt to any regulated manufacturing process.
MES systems are adaptable and scalable, offering the ability to choose and select the processes to be automated, while also including the ability to design our own or specific processes.
Software for the pharmaceutical industry is divided into two functional modules: eBR, for manufacturing in a BPM factory (Good Practices in Food Industries), and industry experience with Simatic IT and Production Suite products.
The paperless solution consists of different elements (eBR/Batch/PCS7) that are fully integrated into the ISA 95/ISA 88.
- ISA 95 control standard for business control systems
- ISA 88 standard for batch-oriented production
Thus, you can integrate and benefit from the different Siemens solutions: Planner-Sequencer (Preactor), LIMS (R&D Suite), traceability, OEE (Production Suite).
Functional eBR modules
The eBR solution consists of different functional modules, with can be implemented step by step, module by module, according to the needs to be met. This means that the solution includes many pre-validated components.
Core FDA-GMP (Compliance and integration axis)
This module is responsible for recording the necessary operations for the product and for regulatory review purposes, providing the 21 CFR part 11, electronic signatures, audit trail, batch genealogy and electronic records. It is also the integration centre with LIMS, ERP and any third-party automation through OPC, and can be accessed through mobile devices.
Control of materials and monitoring (Warehouse and Packaging)
This module allows for the management and monitoring of materials that pass through the plant, including raw materials and packaging, semi-finished products and final products, while also adjusting to FDA-GMP procedures.
Master Batch Record (MBR) and Electronic Batch Records (eBR)
Complete management of paperless manufacturing, within regulated processes. Compatible with FDA and GMP regulations, optimising batch manufacturing, documents and processes. It maximises all resources: user guide, assignment of equipment and standardised work procedures. Each of these operations is within the execution of production, either manually or through a PLC, which are monitored and controlled. With the help of exception rules, eBR allows product batch records to be reviewed, improving the time-to-market while considerably reducing the review and release times.
Weighing and dosing
Dispensing and weighing module, including out-of-box weighing modes, and enabling the traceability and reliability of complete weighing operations.
Plant Intelligence (Control Panel)
In a standard ETL solution (this is the process that allows organisations to move data from multiple sources, reformat it and clean it, then load it into another database), it allows users to locate what they need from multiple data sources, while providing tools that allow the data to be manipulated in the required results.
Batch integration layer
The integration layer allows for native integration with Simatic Batch and PCS7. It provides a unique interface with a unified approach from engineering and also during operation, on top of an automated recipe. If you do not have a Siemens system, the system also supports OPC, allowing for the direct exchange of specific data from the equipment.