Qualification and Validation of Single-Use Shipping Systems

May 15, 2016
BP Nicolas Voute

Nicolas Voute is a global product manager for fluid management technologies at Sartorius Stedim Biotech S.A.

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Elisabeth Vachette

,
Delphine Audubey

,
Frederic Bazin

,
Stephane Baud

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2016, Volume 2016 eBook, Issue 2
Page Number: s43-s50

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

As the biotech industry evolves, there are mounting concerns about the transportation, security, and robustness of cell-culture media, intermediate, or bulk drug substance (BDS). Safe, stable, and closed systems are needed when sterile products are shipped in single-use bags. In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

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