PAT system can save millions of dollars per year

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. The control system then makes adjustments to the control outputs to improve or optimise the process.

Being scalable, it can be deployed within a development environment and then scaled-up to the production plant. Similarly, it can be applied to a single process unit, such as a dryer, or implemented across a full production facility.

Engineering and consultancy

Additionally, due to its ability to provide consultative services to companies in the pharmaceutical and allied industries, ABB can supply engineering expertise to interpret the FDA initiative. This includes identifying the benefits of using PAT, validation, and business expertise to aid the co-operation between the many different client departments - such as quality control, validation, automation and chemists.

ABB says the potential benefits of utilising IIT for PAT are as follows:

• Up to 40 per cent reduced cycle times
• Up to 30 per cent reduced production costs
• Improved production consistency
• Improved right-first-time production levels from 90 to 99.9 per cent
• 50 per cent reduction in non-value-added time and costs in laboratory testing and paperwork
• Change purely batch processes into continuous manufacturing processes
• Reduced inventory
• Reduced costs and regulatory issues in scale-up from laboratory to production

IIT for PAT has been developed by ABB in response to customer demands and the draft version of the guidance document "PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance" published by the USA's Food and Drug Administration (FDA) in 2003.

Centre of excellence

The benefits of PAT have been promoted by the FDA and industry groups with the aim of moving pharmaceutical manufacturing from low-efficiency to high-efficiency; from high-cost to low-cost; and from quality-by-testing to quality-by-design. Thomas Buijs, from ABB's pharmaceutical centre of excellence, explains: "The aim is to focus on the process rather than the end product."

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.

The adoption of PAT has been hindered by a lack of technology that consistently integrates automation systems with the different analytical techniques typically used in pharmaceutical manufacturing.

Integrated system

ABB's IIT for PAT is said to fill this technology gap by providing a vertically integrated system for analytical instruments, chemometrics and control systems. IIT for PAT therefore enables ABB's customers to implement PAT within their processes and realise the potential economic and quality benefits.

Maurice Wilkins, senior technical advisor for ARC, states: "ABB's IIT for PAT is the world's first fully integrated PAT solution. 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."

Buijs adds: "This is a revolutionary platform that 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. 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."

ABB reports that its clients view ABB as being a year ahead of its competitors in terms of a complete PAT system for the life science sector. Part of the reason for this is that ABB has been working extremely closely with a global pharmaceutical company for two years to ensure that the system now being launched does, indeed, match the true needs of the life science industry. Moreover, a pilot implementation indicated that savings of $10million per year can be achieved by applying IIT for PAT to just three dryers - which suggests a very short payback period.