The Common Road to Quality for Single Use Materials

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Presented by

Trishna Ray-Chaudhuri, at Roche Group, Donald Young at Thermo Fisher and Marcus Bayer at Hamilton Company

About this talk

Single use system (SUS) quality needs are similar to requirements used for their stainless steels analogs.  As an example, a user implementing a stainless-steel system must oversee the design completely and is responsible for process validation.   Similarly, when a user retrofits a stainless-steel system, the user and SUS supplier partner to demonstrate equivalent levels of quality and process control.  The supplier is responsible for manufacture, cleanliness and sterilization while the end-user remains accountable to the regulatory agency for the quality of the process and final drug product. This webinar will review the current best practices for implementation of single use systems with regard to quality, specifications, and user requirements.  The content was created in partnership with companies and suppliers across the industry and represents the current perspectives for best practices.

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