Live from WBF 2008--The Challenge of Integrating Multiple Batch Systems to Global Business Systems
•With proper legislation the development process of the future will be much more refinedThe most important single obstacle is humans. “Our” way of in a persistent sociological, corporate or institutional culture to avoid using already existing products,research or knowledge because of its different origins. NIH = Not Invented Here! Manufacturing Scheme Traditionally, we have had "build to order" processes. In the future, we need new completely modular process modules. Process Modules are VPEs and all COTS “Self-contained” Mechanical, Instrumentation and Controls for the specific Process Functionality e.g. Chrom, Centrifuge, Reactor … Pre-validated Basically no interface between Process Modules Product Movement No piping Bags, IBCs and other types of product containers Flexible Product Storage by use of Farm Modules Capable of: Controlling and Maintaining product and environmental conditions Interfacing to overall MOM General: Up to daily product changeovers Different product in different units of same facility/train Unclassified space Unrestricted substitution of Process Modules (VPEs) Using identical “skid-stations” where Process Modules are hooked up Process Modules physically isolated yet Procedurally Connected 10-100 products per facility Currently product changeovers might take as long as 100 days. In the future, we should expect to see as much as 40% reduction in Time to Market delay. Product Change Over Facility utilization increased from 65% to 95 due to reduction in Downtime for product changeover Requires Pre-configured modules Pre-validated modules Plug-n-Play methodology for changeover High flexibility for Procedural Control Agile Systems and People We have not yet come to a point where we've created a standard that addresses these issues in a good way. Going Forward What can we as “Automation and Batch practitioners” bring to the table? Shift into a much higher gear on standardization work With the visionary Pharma companies, other forums like ISPE and other people to analyze and establish a Business Model for the new way of doing Medicare Create a common standard for 88 and 95 areas or redefine the 95 standard to defining the complete Manufacturing Operations Management as a generic business and software model that is not specifically targeted towards Batch, but that will also accomplish the task of Batch Control Investigate and explore technologies and standards used in other IT areas to create a basis for understanding how to enable integration across systems and software platforms and technologies Extend the current work done by Make2Pack and create a real compliance standard for integration of VPEs to the MOM (the Plug-n-Play standard) Secure the “buy-in” from Automation and IT vendors, as without them we can do nothing And finally, we should stop NIH.