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Moving to Closed Systems for Aseptic Processing
Leonard Mestrandrea
LeonardMestrandrea is principal of Mestrandrea Consulting LLC.
James P. Agalloco
James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.
Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
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).