Qualification and Validation of Single-Use Shipping Systems

Publication
Article
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-.jpg
Measuring and Removing Genotoxic Impurities
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Qualification and Validation of Single-Use Shipping Systems
The-Evolution-of-Planning.jpg
The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage
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Revised ISO Cleanroom Standards Improve Air Cleanliness Classification
Lessons-Learned-Accelerate-Vaccine.jpg
Lessons Learned Accelerate Vaccine Development
Protecting-the-Product-and-the-Patient.jpg
Protecting the Product and the Patient
Deconstructing-the-Regulatory.jpg
Deconstructing the Regulatory Spiral
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Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
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