LeonardMestrandrea is principal of Mestrandrea Consulting LLC.

Leonard Mestrandrea

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.

Pharmaceutical Technology and BioPharm International

Vaccine Development and Manufacturing 2017

	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

Articles

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.