Articles by Herman F. Bozenhardt

11. Not Your Grandma's Aseptic Filling Line: Letting Go Of Tunnels, Washers, And Other Aseptic Vestiges 3/8/2019

    We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. In each case, the receiving site is focused on schedule and budget. These competing targets often distract personnel from embracing newer technologies, bypassing lower-cost options and faster implementation. 

12. Biocontainment: An Intro To Control Levels & Practical Design Concepts 9/4/2017

    The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained. Finally, we will provide some practical (and required) design and building concepts that must be integrated into the GMP process to satisfy the FDA and EU.