Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
Qualification and Validation of Single-Use Shipping Systems
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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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.
Articles in this issue
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Measuring and Removing Genotoxic Impuritiesover 10 years ago
Lessons Learned Accelerate Vaccine Developmentover 10 years ago
Protecting the Product and the Patientover 10 years ago
Deconstructing the Regulatory SpiralAdvertisement
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