With Sipat Siemens is launching a new software solution to support the applica-tion of Process Analytical Technology (PAT) in the pharmaceutical industry. Sipat is scalable and modular and allows a controlled quality growth as the PAT initia-tive expands. The new software solution serves as a common user-friendly inter-face for all PAT tools and can be fully integrated into the manufacturing and de-velopment architectures. The main feature is the ability to interface with an exist-ing manufacturing architecture, allowing full transparency on quality aspects from unit operation level up to ERP, MES and LIMS. With Sipat pharmaceutical companies are now able to gather process understanding, strive for continuous process improvement, develop processes based on ‘quality by design’ principles and to manufacture ‘right-first-time’. Regulatory and financial forces are pitching pharmaceutical manufacturing towards ra-pid change. Process Analytical Technology (PAT) is an exceptional opportunity for pharmaceutical companies, to improve manufacturing performance, reduce manufactur-ing costs, reduce time to market and improves supply chains responsiveness. PAT al-lows to design quality into the process and move to real-time product release. Sipat is a scalable and modular software solution which allows a controlled quality growth as the PAT initiative expands, moving from off-line to on-line process investiga-tion, followed by controlling the process and then on towards a full real-time product release capability. Sipat serves as a common user-friendly interface for all PAT tools and can be fully integrated into the manufacturing and development architectures. Sipat integrates process analyzers, process control tools, data analysis & mining tools (multi-variate data analysis), data collection, storage and retrieval tools, reporting tools and continuous improvement and knowledge management tools. One of the key features is the ability to interface with an existing manufacturing architecture, allowing full transpar-ency on quality aspects from unit operation level up to ERP, MES and LIMS. It enables the capture of analytical and process measurements, model creation and validation, online prediction and analysis, feedback to process control and, finally, real-time prod-uct release. With Sipat pharmaceutical companies are now able to gather process understanding, strive for continuous process improvement, develop processes based on ‘quality by design’ principles and to manufacture ‘right-first-time’.
Thanks to Siemens’ wider cross-industry experience of PAT and its close interaction with the FDA, EMEA and various PAT related initiatives, like ASTM E55, Siemens has expert knowledge and offers a multidisciplinary PAT solution. Siemens possesses all the know-how, services and the right tools to guarantee a successful PAT implementa-tion.
Thanks to Siemens’ wider cross-industry experience of PAT and its close interaction with the FDA, EMEA and various PAT related initiatives, like ASTM E55, Siemens has expert knowledge and offers a multidisciplinary PAT solution. Siemens possesses all the know-how, services and the right tools to guarantee a successful PAT implementa-tion.
