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Solution scenarioValidated Pharmaceutical plant Overall enterprise integration in a validated environment
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 • Total plant pharmaceutical industry validation This large pharmaceutical manufacturing facility produces over 3 billion tablets annually
Additional requirements • 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 • 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 • Data is collected into the Enterprise Historian • ABB application consolidates the batch record and forwards it to SAP
SAP Production scheduling, orders, final batch records Barcode system Process management Production supervision & accounting Mixing system Production lines Product Routing Building control system ABB Solution: architectural view Enterprise Historian
ABB Solution: Enterprise Integration • ERP system interface via SAP certified software (Verano Enterprise Link) • 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 • 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.