Standards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress, and the Impact of Standards Implementation

By Eric S. Langer

Volume 11, Issue 3 (Fall 2012)

Only a year ago, the lack of standards for single-use equipment systems (SUS), as covered in this journal, was cited as inhibiting growth in the bioprocessing industry. The need to establish more standardized approaches for single-use devices’ design, quality, and leachables/extractables that regulators and industry end-users could accept was slowing the acceptance rate of these novel devices…

Citation: Langer ES. Standards-Setting for Single-Use Equipment in Biopharmaceutical Manufacturing: An Update on Progress, and the Impact of Standards Implementation. BioProcess J, 2012; 11(3): 20-26. https://doi.org/10.12665/J113.Langer

Posted online October 22, 2012

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