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Manufacture Bioprocessing - Single Use Systems, Standards & Regulation, Supply Chain

Standardize for Success

Recent years have seen considerable growth in the adoption of single-use technologies in the biopharmaceutical industry. By eliminating the long, resource-intensive decontamination and sterilization steps associated with multi-use equipment, single-use has proven that it can help biopharmaceutical organizations boost operational efficiency, improve product quality and consistency, and reduce costs. However, increased demand for single-use is straining supply chains and delivery timelines – an issue I believe standardization can alleviate.

Standardization has historically proven challenging because biopharmaceutical organizations typically require highly specialized (often custom) single-use designs to meet their workflow needs. And if standardization practices are not properly executed and managed, it can be difficult to control configurations that have been functionally optimized and qualified for use in multiple applications. If the same design is being used across different workflows and facilities, for example, we must employ appropriate processes to ensure that any subsequent revisions will not impact the various applications.

 

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About the Author

Jerry Branscomb

Senior Product Manager of Single-Use Technology for Standardization and Harmonization at Thermo Fisher Scientific

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