Siemens launches software support for PAT implementation
Process Analytical Technology (PAT) in the pharmaceutical industry
with the launch of its Sipat package.
Sipat acts as a common user-friendly interface for all PAT tools and can be fully integrated into existing manufacturing and development architectures, Siemens says. The software provides continuous process improvement at both these levels as well as advanced process control, whether focusing on specific units or covering total batch quality to enable real-time product release. Siemens promises a range of benefits from incorporation of its software, including significant cost reductions (e.g., through reduced need for raw material, intermediate and finished product stocks), improved quality (built-in quality control cuts the risk of product contamination), shorter time-to-market (validation optimisation makes for easier regulatory compliance) and improved company image (reduced risk of recalls/warning letters/consent decrees). PAT involves the use of in-process measurements to improve the quality of production processes, boost yields and cut wastage. When the US Food and Drug Administration (FDA) published guidance on Process Analytical Technology in October 2004, the batch-oriented manufacturing processes in the pharmaceutical industry had evolved little over the previous few decades, in stark contrast to advances in the petrochemical and even the food industries. This had left drug companies with a considerable burden in proving that changes in manufacturing processes did to mean changes in product quality. The FDA's initiative encouraged companies to monitor their production processes continuously and automatically in real time, rather than intermittently and historically via samples and post-manufacturing quality control. PAT enables companies to manufacture "right first time", Siemens noted. In this way, post-process testing is reduced or eliminated, as is off-spec production, lowering manufacturing costs in turn. While the PAT methodology is not yet mandatory, it "will most probably set the regulatory standard-reference in the pharmaceutical industry in the 21st century", the company commented. Sipat is a scaleable and modular software solution that allows controlled quality growth as the PAT initiative expands, Siemens explained. The package includes process analysers, process control tools, data analysis and mining tools (e.g., multivariate data analysis), data collection, storage and retrieval tools, reporting tools, and continuous improvement and knowledge management tools. One of the software's key features, the company said, is its ability to interface with an existing manufacturing architecture, allowing full transparency on quality from unit operation level up to enterprise resource planning (ERP), manufacturing execution systems (MES) and laboratory information management systems (LIMS). Sipat provides for analytical and process measurements, model creation and validation, online prediction and analysis, feedback to process control and, at the end of the line, real-time product release. Product quality information can be monitored and consolidated, allowing for real-time quality decision-making. Sipat is part of a multidisciplinary Process Analytical Technology solution offered by Siemens, the company pointed out. This draws on wider cross-industry experience of PAT as well as Siemens' close interaction with the FDA, the European Medicines Agency (EMEA) and various PAT-related initiatives, such as the Committee E55 on Manufacture of Pharmaceutical Products set up in 2003 by the voluntary standards development organisation ASTM International.
