Title: Critical Attributes in Single-Use Technologies Qualification and Validation
Date: Thursday, September 5, 2013
Time: 11:30 AM - 12:30 PM EDT
About the web seminar:
The biopharmaceutical industry increasingly relies on single-use flexible containers for the critical functions of packaging, transport, storing and manufacturing of liquids and powders used in bioprocessing. The fact that single-use technologies are now employed throughout the biomanufacturing workflow, from media preparation to bioreactor cultures to bulk biologics storage, adds to the difficulty in establishing appropriate testing procedures and specifications. The applications integrity and performance of stored contents depends primarily on the characteristics of the film, the largest component (product contact surface area) of any flexible container system. Numerous physical, chemical and biological properties must be measured in such steps as extactables and leachables testing, cell-based assays and many other tests. The impact of components sourced for manufacturing film used in single-use technologies also plays a critical role.
As the application of single-use technologies has grown over the past decade, so have the means by which these systems can be tested. This presentation will cover new approaches to validating the quality and performance of film used in single-use technologies.
Register for the web seminar here.
This web seminar is presented by:
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