Emerson Exchange 365
Blogs
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...