OPTI-CLEAN
Effective and reliable optical system for cleaning validation in pharmaceuticals manufacture
| Coordinatore | INNOPHARMA LABS LIMITED
Organization address
address: ASHFIELD CRONE LOWER contact info |
| 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
| # | ||||
|---|---|---|---|---|
| 1 |
INNOPHARMA LABS LIMITED
Organization address
address: ASHFIELD CRONE LOWER contact info |
IE (REDCROSS) | coordinator | 678˙282.00 |
| 2 |
RIKOLA LTD OY
Organization address
address: KAITOVAYLA 1 contact info |
FI (OULU) | participant | 181˙302.00 |
| 3 |
KUAVA OY
Organization address
address: MICROKATU 1 contact info |
FI (KUOPIO) | participant | 138˙760.00 |
| 4 |
MANUFACTURAS SERVIPLAST SA
Organization address
address: CL COBALTO 13 contact info |
ES (Hospitalet Llobregat) | participant | 115˙769.00 |
| 5 |
DUBLIN INSTITUTE OF TECHNOLOGY
Organization address
address: RATHMINES ROAD LOWER 143-149 contact info |
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 contact info |
ES (Castelldefels) | participant | 10˙282.00 |
| 7 |
MERRION PHARMACEUTICALS IRELAND LTD
Organization address
address: "LAKE DRIVE, CITYWEST BUSINESS CAMPUS 3200" contact info |
IE (DUBLIN) | participant | 6˙480.00 |
| 8 |
TEKNOLOGIAN TUTKIMUSKESKUS VTT
Organization address
address: TEKNIIKANTIE 4 A contact info |
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.