MES Helps to Fill & Finish at Biopharma Operations

At its Biberach production site in Germany, Boehringer Ingelheim is carrying out its aseptic fill & finish processes and 100% visual inspection in BioPharma Operations with PAS-X Manufacturing Execution System (MES) software. Boehringer Ingelheim had already been using Werum’s MES since 2002 to manufacture biopharmaceutical active ingredients in the largest cell culture plant in Europe. When it started production, this plant also set new technological standards. Specific criteria and conditions must be considered for fill and finish processes. All relevant information on preceding production stages with a significant effect on the sterility of the finished product must be documented, such as passing airlocks, autoclaving, or decontamination. Defined procedures and expiry dates have to be observed. In state-of-the-art clean rooms, which meet the standards specified by international authorities, the active ingredient batches produced with PAS-X are aseptically filled into vials or syringes and some are freeze-dried. A number of products are temperature-critical and have a limited expiry date at room temperature. The system must ensure that their expiry dates are not exceeded. When the filling process is complete, all products are required to undergo a 100% visual inspection before they are packaged and released. PAS-X has proven its worth in biopharmaceutical active ingredient manufacturing. Now it is also becoming the hub of operative process control in fill & finish and visual inspection operations. The most important MES functions in this area include Master Batch Records Management, which defines all process specifications, and Electronic Batch Recording, which is responsible for the actual execution processes. The system ensures that equipment statuses and batch or log information about individual objects are exchanged within the supply chain. In addition, the Finite Scheduling function in PAS-X enables finite planning of processes, and its Warehouse Management function controls all in-company logistics operations. PAS-X has made it possible to integrate the fill and finish process seamlessly into the IT landscape of Boehringer Ingelheim. In particular, this integration work involved the ERP system (SAP), the LIMS system and the systems for deviation and document management.