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Herman & Erich Bozenhardt

Herman Bozenhardt has 44 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance. He is a recognized expert in the area of aseptic filling facilities and systems and has extensive experience in the manufacture of therapeutic biologicals and vaccines. His current consulting work focuses on the areas of aseptic systems, biological manufacturing, and automation/computer systems. He has a B.S. in chemical engineering and an M.S. in system engineering, both from the Polytechnic Institute of Brooklyn.

Erich Bozenhardt, PE, is the process manager for IPS-Integrated Project Services’ process group in Raleigh, NC. He has 14 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems. He has a B.S. in chemical engineering and an MBA, both from the University of Delaware.


  • Who The Heck Designed This Biopharm Plant?

    The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.

  • Shocking! Biotech Facilities Don't Maintain Themselves

    Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

  • Let's Clean Up That Bioburden — The Aseptic Suite's Persistent Plague

    After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

  • Help! The Particle Count Is Overwhelming Us!

    Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

  • Key Considerations For Decarbonizing Your Biotech Facility

    Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

  • Facilities Remediation, Renovation & Reconstruction: When Does It End?

    We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

  • Bioprocess Facility Design — Layout Rules And Configurations

    The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.

  • An Introduction To Biopharma Facility Design & Layout

    This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

  • Expansion Options For Adherent Cell Therapy

    While the stirred tank bioreactor is the workhorse of the biopharmaceutical industry, there are applications for which cells can’t be effectively cultured in suspension. Beyond the petri dish and the T-flask, many in our business have not had interactions with the numerous and sometimes niche solutions for adherent cell culture. This article discusses our options in this field.


  • PIC/S Annex Update: What Is Your ATMP Control Strategy?

    Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.