Case Study: How to ensure sterility in end-to-end bulk management?

Sporadic product loss through cross contamination has made a global CMO (Contract Manufacturing Organization) reflect on their current operation system of  bulk drug substance management. The goal was to find a seamless and 100% sterile end-to-end system between downstream and fill & finish.

The implementation of a closed system was inevitable in order to guarantee sterility. So the CMO figured out that the combination of temperature resilient and radically simple sterile connectors together with the most robust and single use bag tailored protection thoughout its whole journey from filling, freezing, storing, shipping, thawing and draining was the best formula to ensure sterility.

The case study depicts how the implementation of Single Use Support and CPC products positively impacted on the performance of the company.



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