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Single-use technology has established itself as an integral part of the biomanufacturing process - helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single-use systems, and advances in equipment such as sterile connectors have facilitated many of these operations. Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.
This webinar will explore Pall’s approach to incorporating user requirements in developing the Kleenpak® Presto sterile connector, the next generation genderless sterile connection technology for aseptic fluid handling and management in single-use biopharmaceutical manufacturing.
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Meet the authors from the ‘Insights on Successful Gene Therapy Manufacturing and Commercialization’ ebook
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