Qualification and Validation of Single-Use Shipping Systems
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Pharmaceutical TechnologyPharmaceutical Technology-05-15-2016
Volume 2016 eBook
Issue 2
Pages: 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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Articles in this issue
Measuring and Removing Genotoxic Impurities
Qualification and Validation of Single-Use Shipping Systems
The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage
Revised ISO Cleanroom Standards Improve Air Cleanliness Classification
Lessons Learned Accelerate Vaccine Development
Protecting the Product and the Patient
Deconstructing the Regulatory Spiral
Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
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