Emerson Exchange 365

Activity

Increasing Autoclave Reliability via Machine Learning Technology

Jim Cahill

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 of ET (Engineering…
- 13 Feb 2018
Designing and Building Pharmaceutical and Biotech Smart Factories

Jim Cahill

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…
- 7 Feb 2018
Digital Transformation to Paperless Production

Jim Cahill

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…
- 2 Feb 2018
Reducing Execution Errors in Cell Therapeutics Manufacturing

Jim Cahill

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…
- 18 Jan 2018
Digital Twin for Increased Project and Operational Performance

Jim Cahill

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. [2] …
- 17 Jan 2018
Managing the Chain of Identity in Cell Therapeutics Manufacturing

Jim Cahill

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

Jim Cahill

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
Successfully Implementing Process Analytical Technology

Jim Cahill

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. In an ISA…
- 31 Oct 2017
Integrating Analytics Across Process Development Lifecycle

Jim Cahill

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 indicate the…
- 11 Oct 2017
3 Ways to Improve Packaging Line Flexibility for Increased Production

Jim Cahill

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…
- 21 Sep 2017
Pharmaceutical Wireless Instrumentation Retrofits

Jim Cahill

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…
- 23 Aug 2017
Improving Batch Manufacturing Workflows and Recordkeeping

Jim Cahill

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 that the…
- 29 Jun 2017
Improving Pharmaceutical and Biotech Plant Utility Performance

Jim Cahill

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…
- 26 Jun 2017
Enabling Right-the-First-Time Manufacturing

Jim Cahill

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…
- 5 Jun 2017
Improving Raw Material Management Productivity

Jim Cahill

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 increase overall…
- 4 May 2017
Challenge of Designing PCS-Driven MES Architectures for a Greenfield Facility

Jim Cahill

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…
- 24 Apr 2017
Efficient Technology Transfer across Life Sciences Product Development Lifecycle

Jim Cahill

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 development…
- 17 Apr 2017
Big Data and Process Analytics for Continued Process Verification

Jim Cahill

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…
- 5 Apr 2017
Automating Bioprocess Single-Use Systems

Jim Cahill

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…
- 24 Mar 2017
Capital Project Efficiency-Operational Flexibility-Product Lifecycle Efficiency at Interphex

Jim Cahill

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…
- 14 Mar 2017
Best Practices Specifying MES Workflows for Life Sciences Projects

Jim Cahill

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…
- 26 Jan 2017
Measurement Repeatability in CIP and SIP Operations

Jim Cahill

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 Kyle…
- 10 Jan 2017
Pharmaceutical and Biotech Manufacturing Data Integrity

Jim Cahill

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 from…
- 10 Nov 2016
Pharmaceutical and Biotech Automation Knowledge Exchange

Jim Cahill

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. …
- 13 Oct 2016
Integrating Single Use Equipment More Easily with Control and Manufacturing Execution Systems

Jim Cahill

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…
- 17 Aug 2016