eMBR – electronic Master Batch Recording

Standard MBR/EBR Approach

In the Life Sciences industry, GMP-compliant definition of production processes are based on master batch records or templates and the order-related executed batch records with which they are associated. The template contains all pharmaceutically relevant data such as the bill of materials, valid SOPs, detailed work instructions that must be applied in production, process steps, process data, Critical Process Parameters and Critical Quality Attributes.

In a paper based environment, the effort to create and maintain master batch records, and complete and verify executed batch reports is huge. Time-consuming and error-prone reconciliation and approval workflows are required to manually carry out the tasks like structuring, maintaining, and managing versions of master batch records or reconciling data between disparate and isolated IT systems. Standardization in the definition of the different processes is even more difficult because information is not always centralized. The analysis of the Key Performances Indicators of executed batch records is only possible after an immense effort of re-entry of the data from the heterogeneous systems.

Electronic Master Batch Recording

In contrast, electronic master batch record management with an MBR/EBR system, is based on master batch records which are subject to automatic version management and contain standardized and reusable building blocks that make it much easier to create and maintain master batch records. The system provides the framework to configure these templates which then generate an empty electronic batch record form for data collection during the production. The MBR then is distributed to respective systems for execution. In this format, the MES has the responsibility of generation, synchronization, collection and batch release while the other systems are responsible for execution and process control. Executed data results are then collected from these systems into an Electronic Batch Record.

There are three principal elements to an eMBR system:

  • eMBR design consists of a Process Instruction text editor which is used to construct both simple and complex building blocks of manufacturing instructions. These blocks are then easily linked via the process workflow.

  • eMBR execution ensures the execution of the electronic Batch Record (eBR) as a set of Process Instructions to be followed, either by the operators, or by the automated system, in order to guarantee the good manufacturing of a product associated to the Work Order

  • eMBR review provides a dashboard to manage deviations, alerts and gather information related to the batch record. The access to this information is used for the easy release of the product batch by reviewing the corresponding batch record with a direct focus on the deviations that occurred during the process.

Native DCS integration to eMBR – the key to manufacturing excellence in Life Sciences

Although the integration between different business and manufacturing systems in the plant is an essential feature of a Life Science MES system, it is often considered that true manufacturing and operational excellence is achieved through a seamless integration between the MES and DCS system during both the process definition (design) and manufacturing execution (operation).

In response to this emerging industry requirement and thanks to the various components being available within the Siemens portfolio, Siemens has worked on a native integration between the MES layer (Simatic IT eBR) and the DCS layer (PCS7 and Simatic Batch).