ABB claims production breakthrough in life sciences industry
4 Jul 2007
IIT for PAT is a “single configurable, scalable system” that collects data from any vendor’s analytical instruments, ABB officials said at a 26 June press conference held at the Royal Society of Medicine in London,
Being scalable, it allows life science companies to apply the solution within a development environment and then scale-up to the production plant, said ABB. The product, it added, can be applied to a single process unit, such as a dryer, or scale-up to the full production facility.
Among other claimed benefits of IIT for PAT, are cycle-time reductions of up to 40%, production cost cuts of 30% and improved production consistency. ABB also pointed to the potential to achieve right-first-time production levels from 90 to 99.9% and a 50% reduction in non-value added time and costs in laboratory testing and paperwork.
ABB developed the product 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, said Thomas Buijs, from ABB’s pharmaceutical centre of excellence. “The aim is to focus on the process rather than the end product,” he explains.
ABB’s IIT for PAT is the world’s first fully integrated PAT solution” Maurice Wilkins, senior technical advisor for ARC, stated in an ABB press release. “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.”