Aseptic fill & finish processes involve unit operations such as sterilisation, filling and lyophilisation, which all need comprehensive reporting and documentation. Boehringer Ingelheim has adopted the latest MES software for handling such crucial operations.
The family-owned drug manufacturer Boehringer Ingelheim has been using Werum’s Manufacturing Execution System (MES) for the production of biopharmaceutical active ingredients in what is the largest cell culture plant in Europe, since 2002. Now, at its Biberach production site in Germany, the pharmaceutical company is carrying out its aseptic fill & finish processes and 100% visual inspection in its biopharma operations with PAS-X MES software. Within the Boehringer Ingelheim Corporation there are two major sites for sterile filling and lyophilisation of bio-pharmaceutical products: Boehringer Ingelheim Pharma in Biberach and Ben Venue Laboratories in Bedford, Ohio, USA.
Maximum sterility
The new 200m2 Biberach fill and finish plant is used for liquid and lyophilisation formulations for proteins and plasmid DNA and can handle filling volumes between 0.2ml and 100ml, with nitrogen gassing before and after filling. Throughput rates of up to 12,000 vials per batch can be achieved for liquid formulations, and up to 7,000 vials for lyophilisation formulations.
Specific criteria and conditions must be considered for the aseptic 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, says Werum, and 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 status 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 systems
PAS-X has made it possible to integrate the fill and finish process seamlessly into the IT structure of Boehringer Ingelheim. In particular, this integration work involved the ERP system (SAP), the LIMS system and the systems for deviation and document management. CT
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