This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|November 15, 2017
- BioPharm International-11-15-2017
- Volume 2017 eBook
- Issue 3
Moving to Closed Systems for Aseptic Processing
Author(s)Leonard Mestrandrea, James P. Agalloco
Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
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As the authors write, true sterile manufacturing remains an impossible ideal. In the real world, even the slightest contact with operators can contaminate product. While aseptic processing has brought the industry closer to its goals, closed aseptic processing takes progress much further, by using automaton and isolators to prevent contamination. This article examines general trends but focuses on a technology that has been developed by Medinstill, that significantly reduces the risk of contamination and allows unclassified rooms to be used to process materials, instead of costly cleanrooms.
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Article Details
Pharmaceutical Technology and BioPharm International
eBook: Vaccine Development and Manufacturing 2017
November 2017
Pages: 31–38
Citation
When referring to this article, please cite it as J. Agalloco and L. Mestrandrea, " Moving to Closed Systems for Aseptic Processing," Pharmaceutical Technology and BioPharm International Vaccine Development and Manufacturing 2017 eBook (November 2017).
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Cold Chain: Delivering Vaccines to Patientsalmost 9 years ago
Using Human Challenge Trials to Develop Flu Vaccinesalmost 9 years ago
Making Vaccines Accessiblealmost 9 years ago
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