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Cell Culture Media Charge << Case Studies

The Challenge
A Bioprocess Engineer at a contract manufacturing (CMO) facility faced various product contamination challenges using their current stainless steel cell culture media transfer lines as identified by elevated levels of bioburden prior to inoculation.

The Saint-Gobain Collaborative Design Services' Solution
Process layouts from their existing stainless steel system were presented to our Design Services Team for the development of a single-use system that could be readily integrated into the cell culture media charge process.

Key design considerations included ensuring the fluid transfer line could withstand 121°C steam in place, peristaltic pump stress and allow for sterile disconnection at the end of the media charge process to multiple primary bioreactors. Achieving leak-proof assurance during this process was of critical importance. Single-Use System was gamma sterilized to ensure contamination free (10-6 SAL) process.

Overmolded tooling needed to meet product requirements was not available during project initiation. However, Saint-Gobain built seven new tools to meet new customer requirements and met their desired timing for the completion of this project.

Customer Experience
The new single-use system allowed the customer product integrity of fluid path and fast turn-around as the single-use assembly was ready for use. This change had a positive impact for the CMO’s manufacturing process and gave them additional confidence in our product design and manufacturing capabilities. After this project was completed, eight additional single-use assemblies were created for this CMO and Saint-Gobain awarded preferred supplier status.

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