Organon Counts on PAS-X for their Production of Active Pharmaceutical Ingredients
 |
| Organon's state-of-the-art facility for the production of Active Pharmaceutical Ingredients (APIs) in Oss, The Netherlands |
Lueneburg, Germany, January 17, 2007 – Organon, the human healthcare business unit of Akzo Nobel and one of the largest manufacturers of Active Pharmaceutical Ingredients (APIs) worldwide, has finished the installation of Werum Software & Systems’ PAS-X MES software in their new state-of-the-art API-powder processing production facility in Oss, The Netherlands.
Mixing and milling as well as a final-product warehouse were combined in this new factory. Organon uses PAS-X for recipe management, weighing and dispensing, shop floor management, electronic batch recording, and warehouse management. Throughout all the manufacturing processes PAS-X has replaced paper-based recipes and SOPs by electronic records. Operators do not only get information about the production processes on screen, but they are also able to give feedback about process parameters by computer.
Mixing and milling are part of the final activities in the overall manufacturing process of Active Pharmaceutical Ingredients. In this stage the final product is already present in a solid form, usually as a powder. Depending on customer specifications this powder must be homogenized and milled or micronized to make it yet finer. In the warehouse final products are received, stored, picked, weighed and either sent to external customers or to other Organon departments.
The primary goal pursued by the implementation of the PAS-X MES system was quality assurance through prevention of mistakes, registration and verification of critical activities and data, acquisition of deviations, and tracking and tracing of batches and equipment. Moreover, the MES system contributes to an improved efficiency through barcode scanning instead of manual entries; through detailed location tracking so that specific batches can be found and picked more easily; and through more effective creation and maintenance procedures for Master Batch Records by authorized employees.
The installation includes manual or computerized interfaces with various systems, such as ERP, Substance Information System, Document Management System (EDMS), and LIMS.
About Werum
Werum Software & Systems (www.werum.com) is a leading supplier of Manufacturing Execution Systems for the pharmaceutical and biopharmaceutical industry worldwide. Twelve of the world's top 20 pharmaceutical companies use Werum's product suite PAS X to run their manufacturing business. Outstanding PAS X features are the functions ensuring compliance and boosting performance. The modular system suite includes components for Production Planning and Scheduling, Master Batch Record Management, Electronic Batch Recording, Weighing and Dispensing, Material Flow Control and Tracking, Equipment Integration, Warehouse Management, Quality Management, and Performance Management based on KPI Analysis. Werum’s solutions and services range from software consulting, creation of functional specifications, and software development to turn-key delivery of integrated and validated Manufacturing Execution Systems. Founded in 1969, the IT company employs more than 280 people in its headquarters in Lueneburg, Northern Germany, the regional offices in West and Southwest Germany, and the subsidiary in Parsippany, New Jersey, USA.
Werum Software & Systems, Tel. USA +1 (973) 644-4000, Tel. Europe +49 (0)4131 8900-0, Press Contact: Volker Mensing, mensing@werum.com