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OPTI-CLEAN

Financiado

Cerrado

Effective and reliable optical system for cleaning validation in pharmaceuticals...

Effective and reliable optical system for cleaning validation in pharmaceuticals manufacture 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 individ... ver más

31/10/2013

INNOPHARMA

1M€

Presupuesto del proyecto: 1M€

Líder del proyecto

INNOPHARMA LABS LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 6 Participantes

Financiación concedida El organismo FP7 notifico la concesión del proyecto el día 2013-10-31 No tenemos la información de la convocatoria

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

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6 Participantes

INNOPHARMA

0.00€ | Lider

INNVACIO I RECERCA INDUSTRIA...

N.D. | Participante

DIT

N.D. | Participante

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Líder del proyecto

INNOPHARMA LABS LIMITED No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 1M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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