Emerson Exchange 365
Blogs
    • 24 Apr 2017

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

    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 when they are needed by the process. The...
    • 17 Apr 2017

    Efficient Technology Transfer across Life Sciences Product Development Lifecycle

    Pharmaceutical and biotech manufacturers are challenged with bringing new medicines and drug compounds efficiently through the development process to provide returns on these investments before exclusivity expires. In a Pharmaceutical Manufacturing article, Tech Transfer: Let’s Take It from the Top , Emerson’s Bob Lenich highlights the importance of a top down approach to technology transfer across the...
    • 5 Apr 2017

    Big Data and Process Analytics for Continued Process Verification

    A biological drug is defined as a: …substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines. The market for biological drugs continues to rapidly grow. In fact, in China alone, there were 201 Biological New Drug Applications (NDAs) in 2016, a 32% increase...
    • 24 Mar 2017

    Automating Bioprocess Single-Use Systems

    For those not in the pharmaceutical and biotech manufacturing industries, if you ever visit one of these facilities you’ll be struck by the clean, shiny stainless steel vessels and piping. Given the importance of hygiene in the production of medicines, most processes include clean-in-place (CIP) and sterilize-in-place operations (SIP). The capital costs and ongoing time requirements for this stainless-steel equipment...
    • 14 Mar 2017

    Capital Project Efficiency-Operational Flexibility-Product Lifecycle Efficiency at Interphex

    Author: Michalle Adkins At the March 21-23 Interphex 2017 , Emerson exhibitor staff will be discussing three main themes: delivering capital projects on time with lower risk; comprehensive automation solutions for flexible, single-use facilities; and improving efficiency across the product lifecycle. Life Sciences companies are expanding globally in order to provide life-saving or life-enhancing solutions to more...
    • 26 Jan 2017

    Best Practices Specifying MES Workflows for Life Sciences Projects

    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, this can be a challenge. In order to define best practices...
    • 10 Jan 2017

    Measurement Repeatability in CIP and SIP Operations

    One only has to do a Google image search on pharmaceutical equipment to see the clean, sanitary conditions required for pharmaceutical and biopharmaceutical processing. The measurement instrumentation must be able to handle the tough conditions when cleaning and sanitization operations are performed. In a Pharmaceutical Manufacturing article, Ensuring Batch-to-Batch Repeatability in Sanitary Processes , Emerson’s...
    • 10 Nov 2016

    Pharmaceutical and Biotech Manufacturing Data Integrity

    The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP inspections. At the recent Emerson Exchange conference, Emerson’s Michalle Adkins co-moderated the Life Sciences Industry Forum session with experts...
    • 13 Oct 2016

    Pharmaceutical and Biotech Automation Knowledge Exchange

    The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance— Data Integrity and Compliance With CGMP Guidance —and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums, workshops and short courses available for manufacturers in the Life Sciences industries at to October 24-28 Emerson Exchange conference in Austin. ...
    • 17 Aug 2016

    Integrating Single Use Equipment More Easily with Control and Manufacturing Execution Systems

    One of the trends in the biopharmaceutical industries that have taken root over the past decade and a half is the use of single-use, disposable equipment in the manufacturing process. Prior to their use, these facilities relied on inflexible, hard-piped equipment. An American Pharmaceutical Review article highlights the benefits of single-use equipment: Single-use disposable devices and systems have reduced overall...