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Extractables and Leachables USA

October 26-28, 2020
Online

Related Materials

Related presentations, posters, and scientific talks from this event have been posted here for your reference. Please click the associated link to download.

Efficient Management of Extractable & Leachable Data in Process Development, S. Bhal, J. DiMartino
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Poster Schedule

Efficient Management of Extractable & Leachable Data in Process Development
Sanji K. Bhal and Joe DiMartino

Analytical and numerical data collected and compiled for Extractable and Leachable (E&L) studies is often scattered among a variety of systems including email, Microsoft applications (e.g. Excel) and electronic notebooks, to name a few. While scientists have developed practices and processes to compile E&L data to help make decisions, it remains a tedious manual process where simple questions such as "what extractables have been found from material x?" are not easy to answer.

In this poster, we introduce Luminata®—a CMC decision support application that helps project teams address the challenge of effective data management across product development. Luminata enables scientists investigating drug products and enclosure systems to create E&L study maps from data processed in the software of their choice. E&L study data may be assembled from various systems, connecting analytical data with study conditions and observations, in a single software for easy sharing, streamlined access, and effective decision-support. The ability to store E&L study data in one searchable location facilitates risk-assessment of product enclosure materials in drug product development.