Coping with chemical uncertainty
helping pharmaceutical and food companies comply with chemical
limit regulations.
A European Union project funded under the EUREKA programme has designed a software system aimed at helping pharmaceutical and food companies comply with chemical limit regulations.
Companies involved in the drug industry are particularly concerned with accurately measuring the chemical content of their products in order to assure traceability and avoid contamination. However, short-term fluctuations in temperature, humidity and air-pressure or variability in the performance of the measurer can give rise to uncertain measurement results, an issue which the International Organisation of Standardisation says needs to be addressed.
"In the past, companies have already been challenged for uncertainty statements," said Matthias Roesslein of the Switzerland-based EMPA research institute, who headed the project. In the pharma and food industries it is particularly important that contaminants are really below a limit defined by government, he added.
To ensure more reliable chemical measurements, the new software system, called MUSAC, assesses measurement uncertainty in a stepwise fashion. It first asks for the quantities of each chemical and possible variables such as changes in the laboratory temperature, and then calculates the margin of error and simulates uncertainty levels over the production base.
Partners expect that the software will help prevent wrong decisions being made as well as to eliminate cost intensive repetitions of a measurement series. The system is already in the process of being commercialised, with the help of food group Nestle, which is "thinking about using this product in their labs worldwide," according to Roesslein.
The MUSAC partners, which include firms such as Byk Gulden, Merck KGaA, Metrohm, Bachema and Novartis, have also created a spin-off company to market the new software.
