Articles by Herman Erich Bozenhardt

1. Who The Heck Designed This Biopharm Plant? 4/1/2024

   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.

2. Shocking! Biotech Facilities Don't Maintain Themselves 3/4/2024

   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.

3. Let’s Clean Up That Bioburden — The Aseptic Suite’s Persistent Plague 2/16/2024

   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.

4. Help! The Particle Count Is Overwhelming Us! 12/12/2022

   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.  

5. Key Considerations For Decarbonizing Your Biotech Facility 5/4/2022

   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.

6. Facilities Remediation, Renovation & Reconstruction: When Does It End? 2/7/2022

   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.

7. Bioprocess Facility Design — Layout Rules And Configurations 12/9/2021

   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.

8. An Introduction To Biopharma Facility Design & Layout 10/11/2021

   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.

9. Expansion Options For Adherent Cell Therapy 8/4/2021

   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.

    

10. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

    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.