Qualification and Validation of Single-Use Shipping Systems
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 (1). 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.
Transportation of process solution in small-volume bags (nominal volume lower than 20 L) is also a common process that requires less complex packaging solution (16). The exception is the transportation of frozen materials that necessitates temperature-resistant materials and cold-chain logistics (17).