Screening materials and medical products for compounds that may present a risk to health and safety is precisely what Extractables and Leachables (E&L) testing delivers.
Nevertheless, the system under testing is often complex enough to ensure that a different “blend” of compounds will emerge, resulting in a degree of uncertainty during the identification process.
The recurrence of tested items allows recovering of previous characterisation, increasing the efficiency of the identification workflow, reducing errors, and improving the skills of the team. This is crucial when aiming for continuous improvement and easier data sharing between those involved in the process. This makes the accumulated experience one of the most valuable assets in E&L testing, especially for the HPLC/Q-TOF technique, based on hundreds of characterisation studies and resulting in a considerable amount of extractable profile data. The challenge became: how do we manage these large data and ensure that the relevant information is quickly available when needed?
A collaboration between Eurofins BioPharma Product Testing Italy and The Visual Agency s.r.l., a web design data-driven company based in Milan, resulted in a novel tool for E&L identification, the Extractables LC/MS Search Engine or ELSE – a customised web application that allows rapid search of LC/MS results among hundreds of studies performed over the years. Filtering by exact mass, retention time and polarity, ELSE points directly to the relevant information while optional parameters can be used to refine the search. This new tool available for the Eurofins E&L teams strengthens the characterisation capabilities, helping customers reach their goal of achieving the ‘total compounds identification scenario’ requested nowadays by the regulatory bodies in the E&L studies.