Tag: <span>sus</span>

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

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…

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Biologics Production

bioprocessing industry extractables leachables single-use equipment sus sus standards

Disposable/Single-Use Equipment in Biopharmaceutical Manufacturing: Global Standardization Is An Absolute Necessity

Single-use systems (SUS) have been employed in biopharmaceutical manufacturing for over 15 years. Consistent year-to-year growth has been seen both in the total volume of sales and the number of manufacturing steps in which SUS are being used. It is projected that the majority of commercial-scale biologics manufacturing will be done in disposable equipment in the near future because of improvements in SUS design and innovation. These devices can significantly reduce capital costs (for example, stainless steel vessels), eliminate equipment cleaning and sterilization, improve turnaround times, and reduce concerns about microbial contamination within a production facility. As reported in this year’s 8th Annual Survey of Biopharmaceutical Manufacturing, however, the rate of growth in SUS use may be slowing. Contributing factors are: 1) the economy; and 2) the need for more consistent product standardization (e.g., design, quality, and leachables/extractables [L&E]) data that regulators and industry end-users can accept with confidence…

Read MoreDisposable/Single-Use Equipment in Biopharmaceutical Manufacturing: Global Standardization Is An Absolute Necessity

Biologics Production

biopharma biopharmaceutical manufacturing extractables leachables product standardization single-use systems sus sus design sus innovation