Abstract

Abstract This paper discusses how gamma irradiation plants are putting the latest advances in computer and information technology to use for better process control, cost savings, and strategic advantages. Some irradiator operations are gaining significant benefits by integrating computer technology and robotics with real-time information processing, multi-user databases, and communication networks. The paper reports on several irradiation facilities that are making good use of client/server LANs, user-friendly graphics interfaces, supervisory control and data acquisition (SCADA) systems, distributed I/O with real-time sensor devices, trending analysis, real-time product tracking, dynamic product scheduling, and automated dosimetry reading. These plants are lowering costs by fast and reliable reconciliation of dosimetry data, easier validation to GMP requirements, optimizing production flow, and faster release of sterilized products to market. There is a trend in the manufacturing sector towards total automation using “predictive process control”. Real-time verification of process parameters “on-the-run” allows control parameters to be adjusted appropriately, before the process strays out of limits. Applying this technology to the gamma radiation process, control will be based on monitoring the key parameters such as time, and making adjustments during the process to optimize quality and throughput. Dosimetry results will be used as a quality control measurement rather than as a final monitor for the release of the product. Results are correlated with the irradiation process data to quickly and confidently reconcile variations. Ultimately, a parametric process control system utilizing responsive control, feedback and verification will not only increase productivity and process efficiency, but can also result in operating within tighter dose control set points.

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