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Effective and reliable optical system for cleaning validation in pharmaceuticals manufacture

Cel

Cleaning validation in the pharmaceutical industry is the verification that the cleaning procedure used to remove contaminants from equipment surfaces is successfully reproducible. In pharmaceutical manufacture, plants or individual pieces of equipment may be dedicated to individual products or indeed used in multi-product manufacture. Cleaning should be carried out as soon as practical after the end of processing and should leave the plant in a suitable condition for next use. The impact of inadequate cleaning procedures is that any of a number of contaminants may be present in the next batch manufactured on the equipment. Current cleaning validation techniques are largely based on laborious, time consuming and expensive swab sampling techniques, whereby swabs of the cleaned surface are taken and then tested using HPLC techniques in the laboratory. Equipment can be down for days, which poses enormous economic burden in the pharmaceutical industry.

The proposed project will build on the promising results of preliminary research using NIR Chemical Imaging technology to detect on surfaces low concentrations of APIs and detergents used in pharmaceutical manufacture. The results have shown the feasibility of such technology to be used to provide accurate information in real-time, thereby opening up the possibility for the development of a custom-made version of the technology that could be trialled and validated for its use in the pharmaceutical industry as a cleaning validation tool. A portable imaging device will be designed and built and tested on a commonly used APIs and detergents in real pharmaceutical environments in order to validate its effectiveness and reliability. The impact of the uptake of the technology will enable rapid turn-around times, increased through-put and profitability in EU pharmaceutical plants, as well as increased safety standards, which are paramount to safeguarding the health and safety of EU citizens.

Dziedzina nauki

Program(-y)

Temat(-y)

Zaproszenie do składania wniosków

FP7-SME-2011
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System finansowania

BSG-SME - Research for SMEs

Koordynator

INNOPHARMA LABS LIMITED
Wkład UE
€ 678 282,00
Adres
ASHFIELD CRONE LOWER
Y14 REDCROSS
Irlandia

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Region
Ireland Eastern and Midland Dublin
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt administracyjny
Ian Jones (Mr.)
Linki
Koszt całkowity
Brak danych

Uczestnicy (7)

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Ostatnia aktualizacja: 23 Listopada 2015

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Permalink: https://cordis.europa.eu/project/id/285836/pl

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