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Sigma Pharmaceuticals a leading Australian pharmaceutical product manufacturer has undergone a major expansion and redevelopment program costing $60 million that will significantly improve production capacity, efficiencies and provide a platform for future growth. The sites existing manufacturing facilities which were becoming difficult to maintain, especially given the strict requirements of regulatory bodies such as the Therapeutic Goods Administration (TGA).
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A major requirement of the project was the implementation of a ‘paperless’ manufacturing environment, along with a manufacturing process that required a high degree of automation. Dickinson Autocon Systems was chosen as the Systems Partner to provide the complete control system, including the Manufacturing Execution System (MES), which manages the overall process and the automation system, which controls the plant equipment (valves, motors, pumps, etc). The project required full design from field level design to highly complex database design with ERP interfaces. One of the key features of the design of the control system was the building of individual process sequences into distinct process control ‘phases’. Each control phase defines a sequence and a set of input and output parameters. These provide the building blocks for the complete manufacturing and CIP process. This design allows a high degree of flexibility and customisation of each process, as the sequencing of the control phases is done within each MES eBR (electronic bath record), rather than being embedded in PLC logic.
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An essential for the project was to meet the requirements of data storage and security in accordance with Good Manufacturing Practice (GMP). The standard guidelines covering electronic storage of data are the U.S. Food and Drugs Administration (FDA) Code of Federal Regulations 21, Part 11. This Regulation sets forth the criteria under which electronic records are considered reliable, trustworthy and generally equivalent to paper records. The two systems where this was relevant for the project were the MES, and the facility’s Environmental Monitoring System (EMS). The MES includes pre-defined electronic signatures, comprehensive security features and complete audit trails of user actions and executed eBR. It stores data in an industry-standard database. A set of clustered servers and a redundant Storage Area Network (SAN) were used to ensure security of the batch data.
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The project at Sigma Pharmaceuticals Dandenong site, is the first application of a commercially available Manufacturing Execution System ( MES ) to be deployed in the Australian Pharmaceutical Manufacturing industry. MES is the hottest topic in the manufacturing sector as a whole, with all leading application suppliers investing heavily in developing MES software. The key is that manufacturers are looking to improving quality, increasing efficiency and reducing waste. This is perfectly illustrated at Sigma Pharmaceuticals by using MES software and automation, particularly in areas of regulatory compliance and release time of product to be shipped.
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