PATOV - Process Analytical Technology Unit for Online Verification of the CIP Process in the Pharmaceutical Industry

01.01.2011 - 31.12.2012
Research funding project
CIP equipments provide Water for Injection (WFI) along with cleaning agents at predetermined temperatures and pressures for cleaning production equipments in pharmaceutical or food production industry. To conform to high level cleaning regulations, preconfigured, longer than necessary cleaning cycles are followed wasting tremendous quantities of water and cleaning agents. This is followed by laboratory testing of residual samples from the vessels to determine 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, which can be several days in some instances. PATOV intends to automate the cleaning validation procedures and thereby reduce cleaning costs and process downtime while at the same time providing more analytical information to the client. The critical challenges in the project realate to the efficient recovery of residues, continuous sampling and the separation of the liquid component from the returned WFI so that it can be fed into commercially available analysers. However, sufficient technologies do not exist today for the direct 3-phase separation that can remove the solid residues and gas bubbles effectively for real time feeding into analysers. This is the reason, despite the significant potential for efficiency improvements, manual cleaning validation tests are still being carried out in laboratories. While TOC remains the most critical measurement for cleaning validation, once the liquid phase is separated, several different analysers can be used for further analysis as desired by the end user and depending on the process being cleaned.

People

Project leader

Project personnel

Institute

Grant funds

  • European Commission (EU) FP7 IV.2 CAPACITIES Research for the benefits of SMEs 7.Rahmenprogramm für Forschung European Commission - Framework Programme European Commission Call identifier FP7-SME-2010-1 Application number 262107

Research focus

  • Computational Fluid Dynamics: 20%
  • Efficient Utilisation of Material Resources: 80%

Keywords

GermanEnglish
Prozessreinigungcleaning-in-process (CIP)
Verfahrenstechnikchemical engineering
Pharmazeutische Industriepharmaceutical industry
Prozessanalytikprocess analytical technology
Mehrphasentrennungmultiphase separation

Publications