Press release
Boehringer Ingelheim: Fill & Finish with PAS-X
In state-of-the-art clean rooms which meet the requirements of international authorities, the drugs are filled aseptically into vials or syringes. Source: Boehringer Ingelheim
Lueneburg, Germany, June 16, 2009 - At its Biberach production site in Germany, Boehringer Ingelheim is now 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.
Maximum Sterility
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.
Filling and Visual Inspection with PAS-X
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.
PAS-X 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.
Integrated System Landscape
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.
Werum Software & Systems (www.werum.com) is the leading supplier of Manufacturing Execution Systems (MES) for the pharmaceutical and bio-pharmaceutical industries worldwide. Fourteen of the world's top 20 pharmaceutical companies and leading biotech companies use Werum's MES product suite PAS-X to run their manufacturing business. Outstanding PAS-X features are the functions ensuring compliance and boosting performance. Werum's solutions and services range from software consulting, creation of functional specifications, and software development to turn-key delivery of integrated and validated MES. A global partner network ensures reliable local support services. Founded in 1969, the IT company employs 315 people at different locations. Werum is headquartered in Lueneburg (Northern Germany) and has regional offices in St. Augustin and Hausach. Its U.S. subsidiary Werum America is headquartered in Parsippany, New Jersey, and has additional offices in Cary, North Carolina, and in Pasadena, California.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com
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