© ABB - Page 1 Overall enterprise integration in a validated environment Solution scenario Validated Pharmaceutical plant Issues: Enterprise Integration and validation Industry: Pharmaceuticals Overall enterprise integration SAP integration for scheduling and master recipes Enterprise connection to diverse systems including: HVAC, mixing, maintenance management product routing and water systems © ABB - Page 2 Total plant pharmaceutical industry validation This large pharmaceutical manufacturing facility produces over 3 billion tablets annually Additional requirements © ABB - Page 3 Regulatory compliance in the design and deployment of products and systems from the plant floor to the ERP level Process, raw material, and product tracking and control High level of operator interaction Automated sampling data entry ABB Solution: Enterprise Integration © ABB - Page 4 System integration services were provided by ABB Inform IT Enterprise Historian selected as the heart of the ERP/MES/Plant Floor for production related activities Planning functions are logically and physically separated from production. In the event of a network failure, the MES system continues production for days based upon previously downloaded SAP production orders ABB Solution: Enterprise Integration SAP system selected as the basis for recipe development, production planning and material movement and permanent batch records ABB handled distribution and synchronization of recipes across multiple, independently controlled process areas ABB is responsible for the electronic batch record keeping © ABB - Page 5 Data is collected into the Enterprise Historian ABB application consolidates the batch record and forwards it to SAP ABB Solution: architectural view Barcode system Process management Mixing system SAP Production scheduling, orders, final batch records Production supervision & accounting Production lines Product Routing © ABB - Page 6 Building control system ABB Solution: Enterprise Integration ERP system interface via SAP certified software (Verano Enterprise Link) © ABB - Page 7 Production orders Quality data Batch records (schedule) Material short-term tracking Operator interface Automation system interface Peripherals interface Maintenance system (CMMS) interface Historical process recording Industrial IT solution: validation and security Data source uniqueness is preserved © ABB - Page 8 Data can only be entered at one place All operator and maintenance personnel entries recorded (by an electronic batch recording system) Project documentation is available at the Enterprise Historian served up by Netscape Fasttrack web server. Goal is to become paperless.