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Millipore Technical Publications


TB2418EN00.pdfTB2418EN00.pdf
TN- TB2418EN00

PureFlex™ FILM: Extractables Bioreactivity Safety Evaluation Approach

Lit No:TB2418EN00
Year:2009



This paper reviews a risk-based approach followed by a leading biotech customer to perform a bioreactivity safety evaluation of bioprocess container film extractables. Millipore’s PureFlex film was evaluated using this approach and qualified for buffer and media filtration and storage applications. The results of the study are summarized in this paper.

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