In order to gain good process understanding for pharmaceutical development and manufacturing it is often necessary to rely on many different types of process analyzers. Often from many different manufacturers, these analyzers need to be interfaced to a single PAT solution to provide process visibility and analysis by Chemometricians etc. Unfortunately at this time there is no standard for analyzer integration making it difficult for pharmaceutical companies to select the most appropriate analyzer for their application in a common PAT environment. As a major supplier to the pharmaceutical industry of Analyzers for R&D through to primary and secondary processes ABB recognized this issue and has support from other analyzer manufactures for a common Analyzer Devices Integration method. This initiative has received support from many end-users and analyzer vendors and has now been taken up by the OPC foundation. The OPC Foundation has created a working group composed of end-users: Pfizer, GSK, Abbott and vendors: ABB, Mettler-Toledo, Umetrics representing both Process Analytical Technology (PAT) and laboratory industries to develop the information model for all analyzer devices facilitating plug-and-play multivendor interoperability.
This type of analyzer integration is an enabling technology for taking advantage of the FDA initiative for a QbD approach for "Real time product release" using Process Analytical Technology (PAT). Until the standard is available ABB will provide proprietary device drivers that support ABB analyzers as well as analyzers from other companies for the Industrial IT for PAT solution. The Industrial IT for PAT solution provides process visibility, analysis, warehousing, and archiving of data, including spectral, chromatographic and histogram imaging quality attributes and process data. Industrial IT for PAT is scalable from single analyzer and process assessment through to multiple analyzers on multiple process units covering the complete process train from R&D through primary to secondary processes.
For more details please Click Here to read the article on the OPC foundation website at www.opcfoundation.org. Also check out www.abb.com/pharmaceauticals - Industrial IT for PAT