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Effective and reliable optical system for cleaning validation in pharmaceuticals manufacture

Objective

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.

Call for proposal

FP7-SME-2011
See other projects for this call

Funding Scheme

BSG-SME - Research for SMEs
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Coordinator

INNOPHARMA LABS LIMITED
Address
Ashfield Crone Lower
Y14 Redcross
Ireland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 678 282
Administrative Contact
Ian Jones (Mr.)

Participants (7)

MERRION PHARMACEUTICALS IRELAND LTD

Participation ended

Ireland
EU contribution
€ 6 480
Address
Lake Drive, Citywest Business Campus 3200
24 Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Brian Boland (Mr.)
MANUFACTURAS SERVIPLAST SA
Spain
EU contribution
€ 115 769
Address
Cl Cobalto 13
08907 Hospitalet Llobregat
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Enrique Romero (Mr.)
KUAVA OY
Finland
EU contribution
€ 138 760
Address
Microkatu 1
70210 Kuopio
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Antti Vanne (Mr.)
RITA INVEST OY
Finland
EU contribution
€ 181 302
Address
Kaitovayla 1
90570 Oulu
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rikola Raimo (Mr.)
TEKNOLOGIAN TUTKIMUSKESKUS VTT
Finland
EU contribution
€ 6 045
Address
Tekniikantie 4 A
02044 VTT Espoo
Activity type
Research Organisations
Administrative Contact
Mikko Juuti (Mr.)
INSTITIUID TEICNEOLAIOCHTA BHAILE ATHA CLIATH
Ireland
EU contribution
€ 12 800
Address
Grangegorman Lower
D07 H6K8 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Pj Cullen (Dr.)
IRIS TECHNOLOGY SOLUTIONS, SOCIEDAD LIMITADA
Spain
EU contribution
€ 10 282
Address
Calle Velazquez, No 94 Primera Planta
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Digby Colm (Mr.)