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Process Analytical Technology Unit for Online Verification of the CIP Process in the Pharmaceutical Industry (PATOV)
Start date: Jan 1, 2011, End date: Mar 31, 2013 PROJECT  FINISHED 

"A group of European SMEs with expertise in process cleaning and cleaning validation as well as other environmental technologies addresses a major market opportunity in the supply of a Process Analytical Technology (PAT) compliant unit for online verification of Clean-in-Place (CIP) processes used in the pharmaceutical industry. CIP equipments provide Water for Injection (WFI) along with cleaning agents at predetermined temperatures and pressures for cleaning production equipments in pharmaceutical or food processing industry. To conform to high level cleaning regulations, preconfigured, longer than necessary cleaning cycles are followed wasting tremendous quantities of water and cleaning agents. Additional laboratory testing of residual samples from the vessels determines whether further cleaning is required or the production process can resume. This results in long periods of process downtime, while the laboratory results are awaited. PATOV is a project designed to significantly optimise these CIP processes by introducing an online, realtime cleaning validation system that will ensure optimal cleaning, but simultaneously control cleaning time and cleaning agents used. This will enable reduction in cleaning costs and process downtime while at the same time providing more analytical information to the client. The critical challenges in the project relate to the continuous sampling and the separation of the liquid component from the returned WFI so that it can be fed into commercially available analysers. Superiorly, the selection and adaptation of a new analytical technology based on infrared spectroscopy seems to be promising. The project is expected to have a severe potential to improve the efficiency and competitiveness of pharmaceutical and food processing industry with significant benefits on the quality of pharmaceutical and food products available to the public. At the same time PATOV will have direct environmental benefits by reducing water and energy consumption by optimizing cleaning cycle time."
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