Expo sets a new standard in PAT implementation

PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.

What is Expos mission statement?

Davies begins, “Expo Technologies’ mission is to become the PAT implementation partner of choice for the pharmaceutical industry through rigorous design and manufacture of “Unit Operation Specific” measurement devices utilising a Project Management Approach. Expo Technologies is dedicated to the business of Pharmaceutical PAT Implementation.” Where do you operate out of? “Expo support their pharmaceutical clients from PAT Design and Engineering centres in Columbia, MD, St. Louis, MO and Thames Ditton, UK.”

What are Expos particular areas of expertise?

Bragg states, “To get any PAT, starting with an instrument implemented in production requires a whole package besides an exceptionally well suited instrument for that application. In order to make it work in a plant reliably day in day out, the user has to know that the instrument is robust, reliable, documented and documentable for them, in other words, easy to validate and quantify its performance day in and day out.” She continues, “It needs to have software that runs the instrument that allows both local and remote activity, and a range of user expertise from a plant operator, who at present does not understand what that instrument is inside, to the scientist who has designed probably the PAT application, to make all of those things happen together, to get this installed and to get the small engineering tasks like windows, holders and brackets, all done in one package, is our area of expertise.”

Susan, do you give comprehensive support from the first to the last stage?

Absolutley and beyond, maintaining it, offering service agreements for example after it is in the plant to ensure its continued success.”

Paul adds: “And also application strength, so if operators move on, we can go back in and fully train new users on the applications or even refresher training. One mantra we have here is ‘small footprint’, in other words for the device to be as unobtrusive as possible, it cannot have an elaborate revalidation, recalibration process, to work it needs to be simple, and this includes software too, in the sense that it needs to be easy to use.” Davies continues “We understand this, for example our products are touch screen sensitive and have big buttons that are designed for people wearing gloves, every detail is thoroughly considered.”

Susan adds, “Our goal is not to make the manufacturers life more complex by adding sophisticated instrumentation, our goal is to use that sophisticated instrumentation to make their life easier.”

What methodologies does Expo Technologies adopt to ensure you stay at the forefront of the pharmaceutical industries ever changing demands?

“We are extremely focused on pharma PAT implementation, by remaining focused, we are living and breathing pharma PAT every day discussing and thinking about it every day, and by doing so we are becoming more knowledgeable in PAT implementation,” replies Davies. “ I think we are they only ones that does that, I think for other organisations out there in the pharma industry PAT is only a small part of their business, where it is everything to us.”

How long have you been in business for?

“Since before the FDA called it PAT, we started with rinse aid systems just over ten years ago, and now the ePAT devices are newer and more focused. At the point the FDA started with this initiative we were a little bit ahead. Some of the early industry leaders clearly knew that’s what their industry needed, which was vastly facilitated by the FDA saying we will give you the latitude to give it a try” Susan replies.

What do you see as the main inhibiting factors working against PAT implementation?

Bragg starts by saying, “In terms of manufacturing the main factor is regulatory restrictions. The FDA took a different stance with their Pat initiative and said we are going to look the other way and give you the ability to acquire data for informational purposes, with out making a lot of changes to the regulatory filling, but until that initiative there was no freedom on the manufacturers part to catch up.” Davies agrees, and adds “Passed on to us as a PAT implementer, we understand there is a large documentation burden to us as the implementer, we have learned to handle it well over the years, there is a large amount of documentation required, which is understandable.”

Can you please tell us about your ePAT solutions please?

“ePAT denomination is the name we give to a core scalable technology, it denotes that we have designed a PAT for a specific unit operation like ePAT 601, specifically designed to monitor blend uniformity,” comments Davies.

Bragg adds, “Drying, high shear, roller compacting, alternate methods for several processes, they look at cleaning verfications, those are the ePAT family.”

What is next for Expo Technologies?

Davies begins, “I think for us its very much to remain focused on pharma PAT implementation, I think the future is too make the ‘footprint’, the hardware/ software implementation process even smaller, so it becomes even easier to go through the implementation process and maintain support on a PAT device.”

Davies adds, “Using blend monitoring as an example, the ability to take a sample interface and couple that with the blender automatically is where we are heading, to make the devices invisible.”

“I think we will see more automation for plant operators down at the plant floor, matched with more automation back at the control systems within the enterprise so that the data acquired are then treated in a global wise way and capitilise.”

Paul Davies

Paul Davies is Vice President of Expo Technologies LLC. He has 20 plus years’ experience in analytical instrumentation. For the last decade Paul has focused entirely on bringing innovative technology to the Pharmaceutical discovery, development and manufacturing sectors.

Dr. Susan Bragg

Susan Bragg is the Technical Director for new product development and software at Expo Technologies. She was the founder and president of SpectrAlliance, Inc., an innovative leader in process spectroscopic analytical technology for the pharmaceutical manufacturing industry. SpectrAlliancebecame part of the Expo Technologies Group of Companies in 2007.