Emerson Exchange 365

Activity

CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

Jim Cahill

I wanted to share my guest post published at the CPhI Pharma Evolution website. There are some great comments, so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers....
- 23 May 2013
Impact of Single Use Technologies on Automation and Information Management

Jim Cahill

One of the conversations happening among pharmaceutical and biotech manufacturers is around the “facility of the future”. I caught up with Emerson’s Gary Mitchell, a consultant on the Life Sciences industry team. He shared some of the trends prompting...
- 25 Apr 2013
Interphex Panel-Implementing Electronic Batch Records

Jim Cahill

If you’re in the pharmaceutical and biotech industries, you likely know that Interphex takes place today through Thursday at the Javits Center in New York City. On Wednesday at 1:30-2:30pm in 1E10, Emerson’s Michalle Adkins will be leading a panel, Road...
- 23 Apr 2013
Justifying New Tech Investment When the Plant Is Running Full Out

Jim Cahill

I wanted to share my guest post over at the PharmaEvolution.com blog, Justifying New Tech Investment When the Plant Is Running Full Out. It can often be challenging to justify investing in new technology when a plant has spare capacity, as Michalle Adkins...
- 15 Apr 2013
Gain a Deeper Process Understanding through Batch Analytics

Jim Cahill

Models can help bring understanding to complex processes. In batch manufacturing, one of the benefits from generating models from process history data is the process understanding gained by going through the steps of generating and refining the model...
- 12 Apr 2013
Automation Project Justification when not Running at Capacity

Jim Cahill

Justifications for automation investments can be based on many factors—increasing revenues, reducing costs, increasing working capital efficiency, and maximizing the return on fixed capital. How do you justify automation investments from a production...
- 18 Feb 2013
Manufacturing Obstacles in Life Sciences

Jim Cahill

In an article, From Industrial To Investment Strategies In The Life Science Sector, Life Science Leader magazine has a great recap of some of the issues pharmaceutical and biotech manufacturers face in their manufacturing processes. The article highlights...
- 18 Jan 2013
You Already Asked Me That!

Jim Cahill

I recently saw an interesting discussion about the use of consultants. One question that came up was why they seem to ask the same question in slightly different ways or the same question to different functional groups in an organization. Emerson’s Michalle...
- 5 Dec 2012
Examples of Control Performance Improvement

Jim Cahill

An important part of a smooth running plant is optimizing the performance of the control loops. Emerson’s Mark Coughran, a senior process control consultant, describes and shares examples of how loop optimization is a part of a control performance program...
- 29 Oct 2012
Managing the Software Development Lifecycle for Validated Processes

Jim Cahill

For those in the biotech and pharmaceutical manufacturing industries, Emerson’s Chris Amstutz has been sharing a great series of forum posts in the Emerson Exchange 365 community, Life Sciences track. Here are a few examples of some specific SAP to manufacturing...
- 26 Sep 2012
Automating Process Development Labs

Jim Cahill

For pharmaceutical and biotech manufacturers, the process of drug compound experimentation requires robust and reproducible results before the scale up process can begin. Emerson’s Chris Amstutz pointed me to a great whitepaper by Broadley James, Automating...
- 20 Aug 2012
Visualizing and Analyzing Real-Time Batch Data

Jim Cahill

As organizations have started to come to terms with the big data sets they have been collecting, they have started to look for strategies and tools to help them make decisions about what products to make and how to make them most efficiently. For highly...
- 14 Aug 2012
Preparing Your Batch Processes to Add Analytics

Jim Cahill

Over the past several years, I’ve covered the advancements in batch analytics to improve the efficiency of batch processes and spot troubles early enough to avoid or resolve the trouble. There can be many simultaneous complex activities in batch operations...
- 8 Aug 2012
Reducing Time-Consuming Calibration Activities

Jim Cahill

I caught up with Emerson’s Chris Amstutz, whom you may recall from earlier Life Sciences-related posts. Chris leads a team of Life Sciences industry consultants. He shared how calibration is a time-consuming and documentation intensive activity in highly...
- 7 Aug 2012
Avoiding Moisture Variability in Fluidized Bed Dryer Operations

Jim Cahill

In an earlier post, Trends in Process Analytical Technology and Quality by Design, I highlight a point made in the video, “…PAT methods around product moisture, which projected a $2 million annual savings in improved product quality.” The methodology...
- 21 Jun 2012
Trends in Process Analytical Technology and Quality by Design

Jim Cahill

At the recent conference for pharmaceutical and biotech manufacturers, Interphex 2012, Pharmaceutical Manufacturing magazine Editor in Chief Agnes Shanley discussed trends in the industry’s use of process analytical technology (PAT) and quality by design...
- 5 Jun 2012
Interphex 2012 – Real-Time Release in Production Recipes

Jim Cahill

I noted in yesterday’s post that two major industry conferences were happing this week—the pharmaceutical and biotech industry’s Interphex show and the oil and gas industry’s Offshore Technology Conference (OTC). I highlighted happenings from OTC in that...
- 3 May 2012
Efficiently Managing Globally Dispersed Clinical Trial Documentation

Jim Cahill

I had a chance to connect with Emerson’s Michalle Adkins, a Senior Consultant on the Global Life Sciences Industry Solutions team. She shared a story about a leading company, which conducts clinical trials for pharmaceutical and biotech manufacturers...
- 21 Mar 2012
Mistake Proofing Pharmaceutical Production and Documentation Processes

Jim Cahill

As a follow up to the post, Using Operational Excellence Techniques to Understand and Solve Business Problems, Emerson’s Michalle Adkins shared a great story of one pharmaceutical manufacturer’s path to justify technology to help their business objective...
- 29 Feb 2012
Using Operational Excellence Techniques to Understand and Solve Business Problems

Jim Cahill

Pharmaceutical and biotech manufacturers, like other process manufacturers, are under constant pressure to improve the performance of their business—product quality, safety, plant efficiency, and throughput. Emerson’s Michalle Adkins, a senior consultant...
- 15 Feb 2012
Managing the Pharmaceutical and Biotech Technology Transfer Process

Jim Cahill

In a Research and Markets report, Technology Transfer Strategies – A Guide to Maximizing Returns Within the Pharmaceutical and Biopharmaceutical Industries, the authors note: The efficient and effective transfer of new technologies is widely recognized...
- 1 Feb 2012
Faster Product Releases with PAT Methods in Production Recipes

Jim Cahill

This week, the International Foundation Process Analytical Chemistry (IFPAC) is holding their 26th international forum and exhibition in Baltimore, Maryland USA. At this event, Emerson’s Chris Amstutz, Life Sciences industry consulting team director,...
- 26 Jan 2012
ASTM E2500-Early, Targeted Testing Leads to Faster Implementations

Jim Cahill

Last week, I highlighted Emerson’s Heather Schwalje thoughts on Continuous Process Verification per U.S. Food & Drug Administration (FDA) guidelines. In a comment, Pharmaceutical Manufacturing magazine senior editor, Paul Thomas, highlighted a great article...
- 25 Jan 2012
Continuous Process Verification per FDA Process Validation Guidance

Jim Cahill

It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry – Process Validation: General Principles and Practices. I caught up with Emerson’s Heather Schwalje, a senior consultant on the Life Sciences...
- 19 Jan 2012
Planning an Electronic Document Management Project

Jim Cahill

It’s great that Tim Alosi, from Emerson local business partner, New England Controls, was in town this past week. He saw the recent post, Shrinking Batch Record Creation Time and Document Management Complexity. Repligen is one of New England Controls...
- 28 Mar 2011