Posts Tagged ‘Jonathan Lustri’

Best Practice for MES-SAP interface Factory Acceptance Testing

Posted in Life Sciences, Operations Management on Monday, September 24th, 2018. No comments yet
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Author: Jonathan Lustri Almost all Life Sciences manufacturing execution system (MES) projects include an interface to SAP, the enterprise resource management system. This interface is strategic in that this is how the business and production are tied together. It allows the manufacturing floor to be integrated with the business for cost accounting, material planning, and […]

Best Practices for Implementing a Process Control Driven MES System

Posted in Life Sciences, Operations Management on Tuesday, August 21st, 2018. No comments yet
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Author: Jonathan Lustri I have previously been interviewed and written about a process control and MES [Manufacturing Execution Systems] architecture where the batch control logic within the process control system is the single procedural engine. It drives procedural logic and workflows executed by the MES system when called by the process control system. The benefit […]

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
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It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]

Challenge of Designing PCS-Driven MES Architectures for a Greenfield Facility

Posted in Life Sciences, Operations Management on Monday, April 24th, 2017. No comments yet
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Author: Jonathan Lustri I have previously written about a design strategy where the process control system (PCS) is the primary system driving all procedural batch activity within a pharmaceutical process. In this architecture, the PCS ISA-88 procedural model must execute the both automated procedures and call the manufacturing execution system (MES) workflows to be executed […]

Best Practices Specifying MES Workflows for Life Sciences Projects

Posted in Life Sciences, Operations Management on Thursday, January 26th, 2017. No comments yet
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Author: Jonathan Lustri Manufacturing Execution System (MES) Life Sciences projects can be costly and be a challenge to keep in control. The biggest contributor to these challenges are the defining and design of manufacturing workflows. A Workflow is an MES procedural object used to replace the paper batch record. And for greenfield projects in particular, […]