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Pharmaceutical Processing News
News Release from: ABB Automation Tech (Instrumentation + Automation) | Subject: Industrial IT for PAT
Edited by the Processingtalk Editorial
Team on 16 July 2007
ABB launches fully integrated solution
for PAT
ABB launches its Process Analytical Technology (PAT) solution for the life sciences industry, Industrial IT for PAT, which collects data from any vendor's analytical instruments
Industrial IT for PAT (IIT for PAT), is a single configurable, scalable system that collects data from any vendor's analytical instruments thanks to its universal and open standard It then analyses the data to determine the actual condition of the process, before passing the resulting information to the control system
This article was originally published on Processingtalk on 17 Jul 2008 at 8.00am (UK)
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The control system then makes adjustments to the control outputs that will improve or optimise the process.
Being scalable, it allows life science companies to apply the solution within a development environment and then scale-up to the production plant.
Similarly, the solution can be applied to a single process unit, such as a dryer, or scale-up to the full production facility.
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Additionally, due to its consultative services in life sciences, ABB is able to supply engineering expertise to interpret the FDA initiative.
This includes identifying the benefits of using PAT, validation and business expertise to aid the cooperation between the many different client departments such as quality control, validation, automation and chemists.
The benefits of utilising the ABB IIT for PAT:.
* Up to 40% reduced cycle times.
* Up to 30% reduced production costs.
* Improved production consistency.
* Improved right first time production levels from 90 to 99.9%.
* 50% reduction in non-value added time and costs in laboratory testing and paperwork.
* Change purely batch process into continuous manufacturing process.
* Reduced inventory.
* Reduced costs and regulatory issues in upsizing from laboratory to full scale production.
ABB has developed its solution in response to customer demands and the US Food and Drug Administration (FDA) draft version of the "PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance" guidance in 2003.
The benefits of PAT have been promoted by the FDA and industry groups with the aim of moving pharmaceutical manufacturing from low to high efficiency; from high to low cost; and from quality by testing to quality by design.
"The aim is to focus on the process rather than the end product," explains Thomas Buijs, from the ABB pharmaceutical centre of excellence.
Additional benefits of implementing such a system include improved automation and operator safety, reduced product rework and waste, real-time release of product and continuous improvement.
PAT adoption by life science industry users is slowed by the lack of technology that consistently integrates the different analytical techniques, typically used in pharmaceutical manufacturing, with automation systems.
ABB IIT for PAT is a solution that fills this technology gap by providing a vertically integrated solution for analytical instruments, chemometrics and control systems.
Thus, ABB provides an optimal PAT solution for its customers to implement within their processes so that they realise the potential economic and quality benefits.
"The ABB IIT for PAT is the world's first fully integrated PAT solution" says Maurice Wilkins, senior technical advisor for ARC.
"The flexibility and architecture of their product allows customers to easily integrate it into new or existing processes to achieve the benefits that have been promised by PAT.
This is a revolutionary platform which will enable customers to change the way pharmaceuticals are made.
PAT is at the heart of that change and is forcing customers to re-think their whole data infrastructure," says Buijs: "The life science industry is moving fast and is investing significant money and resources.
As a result, ABB is investing more in PAT than any other automation company".
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