Emerson Exchange 365
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    • 111 posts
    • Updated 9 days ago
Activity
    • 11 Jun 2018

    Optimizing Media Flow in Biologics Manufacturing

    Author: Emily Anderson Flexible facilities are a growing trend in the biopharmaceutical manufacturing industry. Manufacturers increasingly look to produce multiple products and maximize production time. To meet these requirements, an automation strategy must maximize the flexibility of the process equipment. The preparation, storage, and distribution of media often requires real-time flowpath selection and bumpless...
    • 30 May 2018

    Moving to Electronic Batch Records

    Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR) . Other elements for the EBR which also have high data integrity requirements include equipment management, material management and batch record process flow and recipe management. In a PharmTech article, Making the...
    • 29 May 2018

    Improving Batch Manufacturing Quality Review Cycle Time

    Exceptions in batch manufacturing processes are the deviations that occur outside the prescribed specifications. For pharmaceutical and biopharmaceutical manufacturers, quality and manufacturing personnel must review these exceptions. Traditionally, this quality review process occurs after the batch has completed. A recent news release, Emerson Helps Life Sciences Companies Reduce Time to Market with Faster Quality...
    • 22 May 2018

    Tech Transfer in Drug Development Pipeline and Industry 4.0

    Author: Zuwei Jin Among all of the important trends in life sciences industry such as modular plants, integrated modules, out-of-box smart factory, single-use equipment, PAT, and manufacturing execution systems (MES) , IIOT has been receiving high interest including among pharmaceutical and biotech manufacturers. It is our view that the same technology advancement that makes Industry 4.0 possible will lead to a...
    • 17 Apr 2018

    Technology Trends for Life Sciences Manufacturers

    We seem to be fully in the swing of industry conferences. This week is the pharmaceutical and biotech manufacturing industries’ INTERPHEX conference in New York City. It: …brings over 11,000 global industry professionals and 650+ leading suppliers together to “Learn It, Experience It, Procure It” through a combination of no cost technical conference, exhibits, demonstrations, and networking events...
    • 13 Mar 2018

    Data Integrity for Pharmaceutical and Biotech Manufacturers

    For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity of this production data is paramount. I connected with Emerson’s Michalle Adkins about what manufacturers are doing to assure this data is accurate and timely. She shared with me some key regulatory standards and best practices. Michalle...
    • 20 Feb 2018

    Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

    We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly. Emerson’s Bob Schiros notes that manufacturing execution systems, such as the Syncade MES , must include...
    • 13 Feb 2018

    Increasing Autoclave Reliability via Machine Learning Technology

    ARC Advisory Group’s Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here’s the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the information and automation technologies employed in the plant), is not new, but the relationship is intensifying. What is changing is the addition...
    • 7 Feb 2018

    Designing and Building Pharmaceutical and Biotech Smart Factories

    Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the plant digitally...
    • 2 Feb 2018

    Digital Transformation to Paperless Production

    Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything. In batch manufacturing processes that produce thousands of batches each year, maintaining paper records for each batch is a time-consuming, error-prone, and costly...
    • 18 Jan 2018

    Reducing Execution Errors in Cell Therapeutics Manufacturing

    In an earlier post, Managing the Chain of Identity in Cell Therapeutics Manufacturing , we highlighted how the manufacturing process of these cell therapies must be performed with absolute accuracy the first time since each batch is produced for a specific patient. It’s critical during the production process that any execution errors be identified and corrected before completion. Any errors in development, manufacturing...
    • 17 Jan 2018

    Digital Twin for Increased Project and Operational Performance

    You may have been seeing the phrase “Digital Twin” more and more in the automation and industry press. Wikipedia defines the Digital twin concept as: …a digital replica of physical assets, processes and systems that can be used for various purposes. [1] The digital representation provides both the elements and the dynamics of how an Internet of Things device operates and lives throughout its life cycle...
    • 4 Jan 2018

    Managing the Chain of Identity in Cell Therapeutics Manufacturing

    Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as : …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for a specific patient. The next unique batch, for...
    • 4 Jan 2018

    Managing the Chain of Identity in Cell Therapeutics Manufacturing

    Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as : …the transplantation of human or animal cells to replace or repair damaged tissue. F...
    • 31 Oct 2017

    Successfully Implementing Process Analytical Technology

    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 practice in an effective way. ...
    • 11 Oct 2017

    Integrating Analytics Across Process Development Lifecycle

    For batch processes found in industries such as pharmaceutical & biopharmaceutical, food & beverage, specialty chemicals, etc., analytics technology advancements are helping to improve quality, consistency and reliability. I caught up with Emerson’s Zuwei Jin for an update on these advancements and how they are being applied. He put together a chart of the process analytics landscape. The orange lines...
    • 21 Sep 2017

    3 Ways to Improve Packaging Line Flexibility for Increased Production

    You only have to walk down a supermarket isle to appreciate the diversity in the packaged goods we purchase. What was once a choice of glass jars or cans for many products now includes re-sealable bags, individual packaged servings, packaging made with recyclable feedstock, etc. Consumers, with their busy on-the-go lives, are creating this demand for convenience. Manufacturers providing these packaged products are...
    • 23 Aug 2017

    Pharmaceutical Wireless Instrumentation Retrofits

    Many industries have benefitted from the use of wireless instrumentation, but how about the pharmaceutical and biotech manufacturing industries? Are there applications which might improve the performance of their operations? In a Pharmaceutical Manufacturing article, Retrofitting Pharmaceutical Processes with WirelessHART Instrumentation , Emerson’s Michalle Adkins and Dan Carlson describe ways that these additional...
    • 29 Jun 2017

    Improving Batch Manufacturing Workflows and Recordkeeping

    The pharmaceutical and biotechnology manufacturing industries are challenged with errors in manual entries in the production process, getting batches right the first time, reaching final signoff for batch release, and managing the data accumulated throughout the production process. I caught up with Emerson’s Mary Sowders about some of these challenges and the way they are being addressed. Mary shared with me...
    • 26 Jun 2017

    Improving Pharmaceutical and Biotech Plant Utility Performance

    For pharmaceutical and biotech manufacturers, the use of steam, heating and air conditioning systems, water and other utilities are an important part of the manufacturing process. Efficient and reliable operations for these plant utilities is very important. In a Pharmaceutical Manufacturing article, Monitoring Plant Utilities for Operational Excellence , Emerson’s Michalle Adkins describes how additional measurements...
    • 5 Jun 2017

    Enabling Right-the-First-Time Manufacturing

    Quality and compliance are indispensable in pharmaceutical and biopharmaceutical manufacturing processes. In a Pharmaceutical Manufacturing magazine article, Crazy About Quality and Compliance? , Emerson’s Michalle Adkins shares how organizational engagement, technologies and work practices must come together for safe, efficient and profitable manufacturing. Michalle opens sharing her experiences in pharmaceutical...
    • 4 May 2017

    Improving Raw Material Management Productivity

    For manufacturers in highly-regulated industries, such as pharmaceutical and biopharmaceutical manufacturing, it is critical to keep track of raw materials as part of the production records. To minimize or avoid waste, it’s also important to use the first-to-expire raw materials from inventory. I caught up with Emerson’s Lynn Richard about his experiences to help a manufacturer solve this challenge and...
    • 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...