Author: Michalle Adkins We are seeing a trend in the life sciences industry moving away from blockbusters to niche busters, population based medicines and even to the extreme of personalized medicines. The Emerson Life Sciences consulting team recently had the...
manufacturing execution system
Optimizing Batch Process Automation Design in MES and DCS
For pharmaceutical and biotech manufacturers, the flow and capture of information is as important as the flow of the manufacturing process in readying products to release for sale. In a Pharmaceutical Technology magazine article, Connecting MES to Process Control,...
Data Integrity for Compliance, Audit Readiness and Performance
Pharmaceutical and biotech manufacturers have stringent regulatory compliance requirements. These requirements must balance with the need for improvement and optimization to run safely, efficiently, profitably and in line with the business and quality objectives. In a...
Conference Room Pilots to Generate Involvement in MES Projects
Author: Jonathan Lustri As a Life Sciences consultant, I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson's biotech customer was highly concerned...
Reducing Communications Problems during Shift Changeovers
Sources of unplanned downtime can be many including equipment failures and human error. For downtime resulting from operator interactions, one major source of errors is the communications breakdown that sometimes happens during a shift change. If not told or seen in...
Prototype Manufacturing Operations Management Projects
The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and...
Improving Technology Transfer by Earlier Adoption of Standards and Software Platforms
In 2011, the U.S. Food & Drug Administration (FDA) published their Guidance for Industry – Process Validation: General Principles and Practices. A PharmManufacturing.com article, A Framework for Technology Transfer to Satisfy the Requirements of the New Process...
Integrated Data Management throughout Drug Development Phases
This week, the Bio International Convention (Bio 2014) is happening in San Diego, California. Several of Emerson's Life Sciences consultants, including Zuwei Jin, are there to discuss some of the issues and trends in pharmaceutical and biotech manufacturing processes...
Optimizing Formulation, Fill and Finish Manufacturing Facilities
Pharmaceutical and biotech manufacturing processes are complex and require well integrated and documented flows of information from upfront forecast demand and customer orders through the production process to inventory receipt and order fulfillment. The components...
Planning Process for Life Science Optimization Projects
For many process manufacturers with lean engineering staffs, partnering with outside automation specialists is critical for successful automation and optimization projects. Emerson's Michalle Adkins, who leads the Life Sciences Industry Solutions consulting team,...
Bridging Islands of Automation
While integration technologies have helped bridge "islands of automation" over the years, some process manufacturers still have parts of their automated processes disconnected from the rest. Emerson's Gary Mitchell, a senior industry consultant on the Life Sciences...
Prototyping Key in Manufacturing Execution System Projects
In an earlier post, Five Strategies for Mitigating Automation Project Risk, we highlighted the importance of prototyping: Risks in budget, schedule, changes, and project execution can be reduced with a prototyping strategy. Prototyping helps incorporate operational...
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