PATOV
Process Analytical Technology Unit for Online Verification of the CIP Process in the Pharmaceutical Industry
| Coordinatore | TECHNISCHE UNIVERSITAET WIEN
Organization address
address: Karlsplatz 13 contact info |
| Nazionalità Coordinatore | Austria [AT] |
| Totale costo | 1˙776˙190 € |
| EC contributo | 1˙246˙355 € |
| Programma | FP7-SME
Specific Programme "Capacities": Research for the benefit of SMEs |
| Code Call | FP7-SME-2010-1 |
| Funding Scheme | BSG-SME |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-01-01 - 2013-03-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
TECHNISCHE UNIVERSITAET WIEN
Organization address
address: Karlsplatz 13 contact info |
AT (WIEN) | coordinator | 53˙600.00 |
| 2 |
PURGATIO AS
Organization address
address: Gammel skolevej EJBY 5 contact info |
DK (KIRKE HYLLINGE) | participant | 440˙500.00 |
| 3 |
GREENPOWER INVEST SPOL SRO
Organization address
address: SPACILOVA 1109/15 contact info |
CZ (BRNO) | participant | 402˙255.00 |
| 4 |
NAGELE MECHANIK GMBH
Organization address
address: Gottlieb Daimler Strasse 72 contact info |
DE (MURR) | participant | 306˙800.00 |
| 5 |
CMC BIOLOGICS AS
Organization address
address: Vandtaarnsvej 83 B contact info |
DK (SOBORG) | participant | 41˙600.00 |
| 6 |
PROCESS DESIGN AS
Organization address
address: GRONHOLTVEJ 16 contact info |
DK (FREDENSBORG) | participant | 1˙600.00 |
Mappa
Word cloud
Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.
Obiettivo del progetto (Objective)
'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.'
Introduzione (Teaser)
A consortium of European small- and medium-sized enterprises (SMEs) and research organisations developed a process analytical technology (PAT)-compliant cleaning unit. The PAT device will enable the online verification of clean-in-place (CIP) processes employed in the pharmaceutical and food industries.
Descrizione progetto (Article)
The PAT unit device was developed by the EU-funded http://patov.eu/ (PATOV) project.
It is based on a continuous sampling device combined with a new and innovative laser-based infrared absorption technique.
This allows the continuous checking of the cleaning cycle of pharmaceutical equipment such as tanks and pipe systems.
Moreover, this can be integrated with existing equipment in accordance with European Hygienic Engineering and Design Group standards.PATOV represents a major shift from sporadic laboratory tests for cleanliness towards continuous in situ verification for every cleaning cycle by pharmaceutical industry end users.
Furthermore, the technology corresponds with future verification techniques for the pharmaceutical industry, as recommended by the European Food Safety Authority and the United States Food and Drug Administration.Integrating PAT into the production process will help the pharmaceutical and food processing industries to increase product safety through reduced contamination from compromised cleaning cycles.
In addition, it will also reduce production costs, water consumption and problems with wastewater.Project results can be applied to existing CIP technology and cleaning regimes in the pharmaceutical industry.
They can also be part of a fully integrated CIP solution developed by SME members of the consortium as an addition or replacement to in situ cleaning procedures.The cleaning unit is suitable for those industries that insist on high standards of hygiene.
This will improve product quality in the food processing, breweries, dairy and pharmaceutical industry, with particular benefits for the public.
It also has environmental benefits through the reduction of water and energy consumption and the optimisation of cleaning cycle time.