OPTI-CLEAN

Effective and reliable optical system for cleaning validation in pharmaceuticals manufacture

Coordinatore	INNOPHARMA LABS LIMITED    more  Organization address address: ASHFIELD CRONE LOWER city: REDCROSS contact info Titolo: Mr. Nome: Ian Cognome: Jones Email: send email Telefono: +353 863422314
Nazionalità Coordinatore	Ireland [IE]
Totale costo	1˙489˙301 €
EC contributo	1˙149˙720 €
Programma	FP7-SME Specific Programme "Capacities": Research for the benefit of SMEs
Code Call	FP7-SME-2011
Funding Scheme	BSG-SME
Anno di inizio	2011
Periodo (anno-mese-giorno)	2011-11-01   -   2013-10-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	INNOPHARMA LABS LIMITED  Organization address address: ASHFIELD CRONE LOWER city: REDCROSS contact info Titolo: Mr. Nome: Ian Cognome: Jones Email: send email Telefono: +353 863422314	IE (REDCROSS)	coordinator	678˙282.00
2	RIKOLA LTD OY  Organization address address: KAITOVAYLA 1 city: OULU postcode: 90570 contact info Titolo: Mr. Nome: Rikola Cognome: Raimo Email: send email Telefono: 358405000000	FI (OULU)	participant	181˙302.00
3	KUAVA OY  Organization address address: MICROKATU 1 city: KUOPIO postcode: 70210 contact info Titolo: Mr. Nome: Antti Cognome: Vanne Email: send email Telefono: +358 50 3566744	FI (KUOPIO)	participant	138˙760.00
4	MANUFACTURAS SERVIPLAST SA  Organization address address: CL COBALTO 13 city: Hospitalet Llobregat postcode: 8907 contact info Titolo: Mr. Nome: Enrique Cognome: Romero Email: send email Telefono: +3493 337 72 48	ES (Hospitalet Llobregat)	participant	115˙769.00
5	DUBLIN INSTITUTE OF TECHNOLOGY  Organization address address: RATHMINES ROAD LOWER 143-149 city: DUBLIN postcode: 6 contact info Titolo: Dr. Nome: Pj Cognome: Cullen Email: send email Telefono: 35314208016	IE (DUBLIN)	participant	12˙800.00
6	INNOVACIO I RECERCA INDUSTRIAL I SOSTENIBLE SL  Organization address address: AVENIDA DEL CANAL OLIMPIC 15 PARC MEDITERRANI DE LA TECNOLOGIA EDIFICIO C4 BLOQUE ANEXO PLANTA BAJA city: Castelldefels postcode: 8860 contact info Titolo: Mr. Nome: Digby Cognome: Colm Email: send email Telefono: +34 935542500	ES (Castelldefels)	participant	10˙282.00
7	MERRION PHARMACEUTICALS IRELAND LTD  Organization address address: "LAKE DRIVE, CITYWEST BUSINESS CAMPUS 3200" city: DUBLIN postcode: 24 contact info Titolo: Mr. Nome: Brian Cognome: Boland Email: send email Telefono: +353 1 6423301	IE (DUBLIN)	participant	6˙480.00
8	TEKNOLOGIAN TUTKIMUSKESKUS VTT  Organization address address: TEKNIIKANTIE 4 A city: ESPOO postcode: 02044 VTT contact info Titolo: Mr. Nome: Mikko Cognome: Juuti Email: send email Telefono: +358 20 722 2144	FI (ESPOO)	participant	6˙045.00

Mappa

 Word cloud

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 Obiettivo del progetto (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.'

Introduzione (Teaser)

Pharmaceutical and biotechnology manufacturers must ensure that equipment is free of contamination before beginning a new production run. A novel portable device exploiting infrared technology could make that process much more reliable.