As part of the Opti-Clean project, which should be completed by October 2013
A European Union (EU) research project commanding a budget of €1.4m is to develop a portable device able to detect minute contamination within pharmaceutical manufacturing lines. Keeping these spotless is of critical importance to the pharma sector to prevent the contamination of medicines. But checking for such contaminants can be a slow process.
The European Commission (EC) said: ‘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.’
As a result, the Opti-Clean project, which should be completed by October 2013, will be developing near infra-red (NIR) chemical imaging technology to detect low surface concentrations of active pharmaceutical ingredients and detergents.
Previous studies have shown such equipment could ‘provide accurate information in real-time’, used by the ‘pharmaceutical industry as a cleaning validation tool’, said the EC.
The project is coordinated by Ireland’s Innopharma Labs, which is working with Merrion Pharmaceuticals Ireland, The Dublin Institute of Technology, Spain’s Innovacio i Recerca Industrial i Sostenible, plus Finland’s Rikola, Kuava Oy and Teknologian Tutkimuskeskus VTT.
‘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,’ added EC.