Emerson Exchange 365

Activity

Continued Process Verification through Process Validation Stage 1, 2 and 3

Jim Cahill

For pharmaceutical and biotech manufacturers, Continued Process Verification is: …the collection and analysis of end-to-end production components and processes data to ensure process is running under the state of control and product outputs are within predetermined quality limits. In an earlier post, Online Multivariate Data Analysis for Continued Process Verification , we mentioned a new approach for performing…
- 18 Mar 2016
Accurate and Repeatable Measurements in Pharmaceutical and Biotech Manufacturing

Jim Cahill

A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements . Emerson’s Michalle Adkins played a role in its contents. The whitepaper highlights: …how reliable, accurate instrumentation allows automation to…
- 15 Mar 2016
Overcoming Pharmaceutical Continuous Manufacturing Challenges

Jim Cahill

Why is there a movement in the pharmaceutical and biotech manufacturing industries to consider continuous manufacturing over traditional batch manufacturing processes? A 2012 U.S. Food & Drug Administration presentation, FDA Perspective on Continuous Manufacturing , captured some of the reasons why. Author Dr. Sharmista Chatterjee listed some advantages: Integrated processing with fewer steps No manual handling…
- 3 Mar 2016
Batch Repeatability through Instrument Performance and Diagnostics

Jim Cahill

Author: Kyle Knutson Batch repeatability is critical in pharmaceutical and biotech manufacturing. Variations between batches that cause deviations require extensive analysis, either in real-time or post-process, to identify how to control and minimize this variation in the future. The consequences of unacceptable batch variation can be anything from extensive maintenance hours, to temporary halts in production or…
- 19 Feb 2016
Life Experiences Shape Consulting Translation Skills

Jim Cahill

Author: Michalle Adkins Before the holidays, I wrote a blog post, Life Experiences from a Woman in STEM, in the Emerson Exchange 365 Women in Stem group. I talked about growing up on a farm where I gained some early experiences with animals, vitamins, medications, pumps, controllers, and valves. I don’t think I realized it at the time, but this coupled with my high school math teacher’s encouragement to go into…
- 4 Feb 2016
Repeating Golden Batch Production

Jim Cahill

For batch-based processes, the “golden batch” is term often used to describe the ideal batch against which all other batches are compared. In a Control magazine article, Data Analytics in Batch Operations , it is defined: …as the time-based profile of the measurement values that were recorded for a particular batch that met product quality targets. When using this standard, a batch is judge by how closely the golden…
- 28 Jan 2016
Is Process Analytical Technology Rocket Science?

Jim Cahill

More than a decade ago, the U.S. Food and Drug Administration published, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance . In this document, the FDA explained: The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, is intended to support innovation and efficiency in pharmaceutical development, manufacturing…
- 21 Jan 2016
Online Multivariate Data Analysis for Continued Process Verification

Jim Cahill

Measuring quality in real-time improves the overall performance of a manufacturing process. The International Foundation Process Analytical Chemistry (IFPAC) is: …a world-wide, not-for-profit organization dedicated to the advancement of Process Analytical Technology and Chemistry. They are holding the IFPAC Annual Meeting later this month in the Washington D.C. area. This meeting provides a forum for discussions…
- 7 Jan 2016
Niche-Buster Medicine Information Solutions

Jim Cahill

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 opportunity to work with one of these emerging companies that is using a novel process that genetically engineers each patient’s own T cells to recognize and…
- 16 Dec 2015
Develop, Test and Train for Lower Risk Projects

Jim Cahill

One way to improve the probability for a successful process automation project is to include dynamic simulation during the design phases to help with configuring the control system, testing before commissioning the system and training the operators before the process goes live. In an earlier post, Building Competency through Operator Training Systems , we highlighted the application of operator training simulators …
- 9 Dec 2015
Optimizing Batch Process Automation Design in MES and DCS

Jim Cahill

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 , Emerson’s Jonathan Lustri is interviewed about advances in using the ISA-88 standard to coordinate manufacturing execution systems (MES) and distributed…
- 27 Oct 2015
Improving Data Management, Analytics and Flexibility in Life Sciences

Jim Cahill

Pharmaceutical and biopharmaceutical manufacturers are challenged on many fronts, such as managing regulatory requirements, operating efficiency, and maintaining the right data required as part of the medicines and products produced. Emerson’s Michalle Adkins was recently at a Life Science Symposium Update session in Europe attended by more than 50 pharmaceutical and biotech company representatives. This symposium addressed…
- 2 Oct 2015
Solving Reactor Temperature Control Challenges

Jim Cahill

Some of my favorite posts are ones that come out of a string of problem-solving email messages. And so it is with today’s post. Emerson’s Mark Coughran was recently at biopharmaceutical facility that was having temperature control issues on a reactor vessel. The temperature process variable was overshooting far past the setpoint with the control loop output failing to reverse this overshoot in a timely way. When it…
- 28 Sep 2015
US FDA Quality Metrics Guidelines Update

Jim Cahill

Author: Eric Kuebler Since the Continued Process Verification (CPV) guidance in 2011, the U.S. Food and Drug Administration (FDA) has been talking quality and verifying process state of control. Now the FDA is getting around to defining what that looks like and what data they want to verify quality. However, the FDA’s push is leaving more questions than answers about what specific date they need, how they will use…
- 3 Sep 2015
Optimizing Life Sciences Processes by Improving Data Integration

Jim Cahill

Pharmaceutical and biotech manufacturers face many economic and technical challenges including reduced prices and diminishing profits, rising research & development costs, increasing regulatory requirements and a greater need for optimized manufacturing operations. In a Pharma Bio World article, Data Integration Challenges and Solutions for Life Science Industry , Emerson’s Michalle Adkins and Ritesh Patil describe…
- 24 Aug 2015
Data Integrity for Compliance, Audit Readiness and Performance

Jim Cahill

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 Pharma Bio World article, The Crossroads of Compliance, Audit Readiness, Profitability, and Data Integrity , Emerson’s Michalle Adkins opens: True…
- 25 Jun 2015
Conference Room Pilots to Generate Involvement in MES Projects

Jim Cahill

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 about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…
- 11 Jun 2015
Advancing the Management of Data through Life Sciences Product Lifecycles

Jim Cahill

From a recent Life Sciences symposium, we looked at issues in the advancement of process intelligence and analytics . Today we’ll look at another work session from the symposium, Managing Data Through the Product Life Cycle. The general session was led by Amgen’s Harmik Begi and Emerson’s Michalle Adkins . The focus of the team addressing these challenges were to explore the end-to-end value chain of product lifecycle…
- 28 May 2015
Advancing Process Intelligence and Analytics in Life Sciences

Jim Cahill

In a recent post, Collaborating for End-to-End Supply Chain Improvements , we highlighted a Life Sciences symposium where challenges to business improvements were discussed as inputs for technology and solution innovation to address these challenges. One of the sessions focused on the needs for process intelligence and analytics for pharmaceutical and biopharmaceutical manufacturers. The topic team included leaders…
- 15 May 2015
Collaborating for End-to-End Supply Chain Improvements

Jim Cahill

You can hardly connect online without coming across articles about big data . Businesses are grappling with how to use this information to improve their businesses—from upfront marketing and sales through improving the efficiency of the supply chain and optimizing lifecycle support. Emerson’s Jonathan Lustri shared background with me of how he is collaborating with a cross section of pharmaceutical and biopharmaceutical…
- 3 Apr 2015
Clarifying Design Space, Process Analytical Technology and Quality by Design

Jim Cahill

The post Clarifying Design Space, Process Analytical Technology and Quality by Design appeared first on the Emerson Process Experts blog. For pharmaceutical and biopharmaceutical manufacturers, there are a lot confusion around the concepts of design space (DS), Process Analytical Technology (PAT), and Quality by Design (QbD). Zuwei Jin Senior Life Sciences Consultant Emerson’s Zuwei Jin believes that this confusion…
- 11 Mar 2015
Prototype Manufacturing Operations Management Projects

Jim Cahill

The post Prototype Manufacturing Operations Management Projects appeared first on the Emerson Process Experts blog. 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 workflows. Click to enlarge . At the…
- 19 Feb 2015
Continued Process Verification in the Process Validation Lifecycle

Jim Cahill

The post Continued Process Verification in the Process Validation Lifecycle appeared first on the Emerson Process Experts blog. In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices . It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state…
- 22 Jan 2015
Enabling Release by Exception Manufacturing

Jim Cahill

Michalle Adkins Manager, Life Sciences Consulting The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson’s Michalle Adkins who mentioned that her team of Life Sciences consultants would be...
- 11 Sep 2014
Improving Technology Transfer by Earlier Adoption of Standards and Software Platforms

Jim Cahill

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...
- 21 Aug 2014